Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function (TOPCAT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by New England Research Institutes.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New England Research Institutes
ClinicalTrials.gov Identifier:
NCT00094302
First received: October 15, 2004
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

The purpose of this study is to evaluate the effectiveness of aldosterone antagonist therapy in reducing cardiovascular mortality, aborted cardiac arrest, and heart failure hospitalization in patients who have heart failure with preserved systolic function.


Condition Intervention Phase
Cardiovascular Diseases
Heart Diseases
Heart Failure, Congestive
Drug: Spironolactone (an aldosterone antagonist)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT)

Resource links provided by NLM:


Further study details as provided by New England Research Institutes:

Primary Outcome Measures:
  • Time to a composite outcome of cardiovascular mortality, aborted cardiac arrest, or hospitalization for the management of heart failure, whichever occurs first. [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to cardiovascular mortality. [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: No ]
  • Time to aborted cardiac arrest. [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: No ]
  • Time to first hospitalization for the management of heart failure. [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: No ]
  • Time to all cause mortality. [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: Yes ]
  • Time to composite of cardiovascular mortality or cardiovascular related hospitalization (i.e., hospitalization for non-fatal MI, non-fatal stroke, or the management of heart failure). [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: No ]
  • Hospitalization for the management of heart failure incidence rate. [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: No ]
  • Time to sudden death or aborted cardiac arrest. [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: No ]
  • Time to new onset diabetes mellitus, in subjects without a history of diabetes mellitus at baseline. [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: No ]
  • Time to development of atrial fibrillation, in subjects without a history of atrial fibrillation at baseline. [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: No ]
  • Time to myocardial infarction. [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: No ]
  • Time to stroke. [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: No ]
  • Time to deterioration of renal function. [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: No ]
  • Time to a composite outcome of sudden death, aborted cardiac arrest, or hospitalization for the management of ventricular tachycardia. [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: No ]
  • Quality of life, as measured by the Kansas City Cardiomyopathy Questionnaire. [ Time Frame: Baseline, Month 4, Month 12 and annually thereafter. ] [ Designated as safety issue: No ]
  • Quality of life, as measured by the EuroQOL visual analog scale. [ Time Frame: Baseline, Month 4, Month 12 and annually thereafter. ] [ Designated as safety issue: No ]
  • Quality of life, as measured by McMaster Overall Treatment Evaluation questionnaire. [ Time Frame: Month 4 and Month 12. ] [ Designated as safety issue: No ]
  • Depression symptoms, as measured by Patient Health Questionnaire. [ Time Frame: Baseline, Month 12 and annually thereafter. ] [ Designated as safety issue: No ]
  • Time to hospitalization for any reason. [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: Yes ]
  • Serum Potassium [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: Yes ]
  • Serum Sodium [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: Yes ]
  • Serum Creatinine [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: Yes ]
  • Serum Chloride [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: Yes ]
  • Serum Bicarbonate [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: Yes ]
  • Serum Blood Urea Nitrogen (BUN) [ Time Frame: Through each subject's last semi-annual visit, up to a maximum of 6 years per subject. ] [ Designated as safety issue: Yes ]

Enrollment: 3445
Study Start Date: August 2006
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
Drug: Placebo
Placebo of spironolactone
Experimental: 2
Spironolactone
Drug: Spironolactone (an aldosterone antagonist)
Spironolactone is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.

Detailed Description:

BACKGROUND:

Heart failure (HF) is a major cause of morbidity and mortality, particularly in older people. Indeed, it is the most common discharge diagnosis in patients older than 65 years. As the United States population ages, heart failure will continue to grow as a public health concern. Therapeutic trials of heart failure have dealt almost exclusively with patients who have systolic dysfunction. However, there is now an emerging awareness that nearly half of the patients with heart failure have preserved systolic function and that the survival of these patients is adversely affected. This study is a randomized clinical trial of a novel therapeutic approach, specifically the use of spironolactone, an aldosterone antagonist, in treating these patients. While this treatment has been shown to be useful in treating heart failure with reduced systolic function, it has not been studied in patients with preserved systolic function.

Patients with heart failure and preserved systolic function have a poor prognosis. The annual mortality rate is intermediate between the prognosis for those without heart failure and for those with heart failure and reduced systolic function. For instance, Family Health Study participants with heart failure and preserved systolic function had a mortality rate of 9% compared to 3% for their age- and gender-matched controls. The mortality rate was 19% in heart failure patients with reduced systolic function heart failure compared to 4% for their matched controls.

As heart failure develops, neurohormones are released that initially improve cardiac output but ultimately contribute to progression of left ventricular dysfunction. The renin-angiotensin-aldosterone system is an important part of this compensatory response. Aldosterone levels may rise to 20 times normal levels in heart failure and aldosterone contributes to the development of myocardial fibrosis. Spironolactone is a potassium-sparing diuretic that acts on the distal tubule, inhibiting sodium and potassium ion exchange. There are several potential beneficial actions, including prevention of cardiac fibrosis. A recent trial evaluated spironolactone in patients with systolic dysfunction heart failure. Spironolactone treatment caused a 30% reduction in mortality compared to placebo (p< 0.001). The improvement resulted from a reduction in all cause mortality. More recently, the Eplerenone Post-Myocardial Infarction (MI) study showed that this aldosterone antagonist significantly reduces mortality despite background treatment with an angiotensin-converting enzyme (ACE) inhibitor and beta-blocker. Advantages of using spironolactone in this study are that it is commercially available, inexpensive, and no longer under patent (therefore this study will not be done by industry). Also, there is a clear physiologic rationale for its use, and the side effect profile is well understood. The study enrolled subjects who had preserved systolic function with heart failure and who met clearly defined eligibility criteria that were selected to make the results widely generalizable to clinical practice.

DESIGN NARRATIVE:

This is a randomized, double-blinded, placebo-controlled trial of aldosterone antagonist therapy (15 mg dose spironolactone or placebo; titrated up to 30 or 45 mg/day) in 3,445 adult patients with heart failure and preserved systolic function. Patients were recruited from August 2006 through January 2012, treated, and will be followed through June 2013. Approximately 270 clinical sites in six countries were subcontracted by the clinical trial coordinating center. Subject visits to a clinical center will occur every four or six months. Data collected include demographic and clinical data, including the results of history and physical exams, laboratory and imaging data, repository specimens for special physiology studies, and genetic studies. Additionally, data regarding quality of life and compliance with assigned treatment will also be collected and assessed.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  • Heart failure as defined by at least one of the following symptoms at the time of screening and at least one of the following signs within 12 months prior to study entry:

    1. SYMPTOMS:

      1. Paroxysmal nocturnal dyspnea
      2. Orthopnea
      3. Dyspnea on mild or moderate exertion
    2. SIGNS:

      1. Any rales post cough
      2. Jugular venous pressure(JVP) greater than or equal to 10 cm H2O
      3. Lower extremity edema
      4. Chest x-ray demonstrating pleural effusion, pulmonary congestion, or cardiomegaly
  • Left ventricular ejection fraction (ideally obtained by echocardiography, although radionuclide ventriculography and angiography are acceptable) greater than or equal to 45% (per local reading); the ejection fraction must have been obtained within 6 months prior to randomization and after any MI or other event that would affect ejection fraction
  • Controlled systolic blood pressure(BP), defined as a target systolic BP less than 140 mm Hg; participants with BP up to and including 160 mm Hg are eligible for enrollment if they are on three or more medications to control BP
  • Serum potassium less than 5.0 mmol/L prior to randomization
  • At least one hospital admission for which heart failure was a major component of the hospitalization some time within the 12 months prior to study entry (transient heart failure in the context of MI does not qualify) OR brain natriuretic peptide (BNP) greater than or equal to 100 pg/ml or N-terminal pro-BNP greater than or equal to 360 pg/ml (not explained by another disease entity) within the 60 days prior to study entry
  • Women of child-bearing potential must have a negative serum/urine pregnancy test within 72 hours prior to randomization, must not be lactating, and must agree to use an effective method of contraception during the entire course of study participation
  • Willing to comply with scheduled visits
  • Informed consent form signed by the subject prior to participation in the trial

EXCLUSION CRITERIA:

  • Severe systemic illness with an expected life expectancy of less than 3 years
  • Chronic pulmonary disease requiring home O2, oral steroid therapy, or hospitalization for exacerbation within 12 months of study entry, or significant chronic pulmonary disease in the opinion of the investigator
  • Known infiltrative or hypertrophic obstructive cardiomyopathy or known pericardial constriction
  • Primary hemodynamically significant uncorrected valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery during the trial
  • Atrial fibrillation with a resting heart rate greater than 90 bpm
  • MI in the past 90 days
  • Coronary artery bypass graft surgery in the past 90 days
  • Percutaneous coronary intervention in the past 30 days
  • Heart transplant recipient
  • Currently implanted left ventricular assist device
  • Stroke in past 90 days
  • Systolic BP (SBP) greater than 160 mm Hg
  • Known orthostatic hypotension
  • Gastrointestinal disorder that could interfere with study drug absorption
  • Use of any aldosterone antagonist or potassium sparing medication in the last 14 days or any known condition that would require the use of an aldosterone antagonist during study participation;
  • Known intolerance to aldosterone antagonists
  • Current lithium use
  • Current participation (including prior 30 days) in any other therapeutic trial
  • Any condition that, in the opinion of the investigator, may prevent the participant from adhering to the trial protocol
  • History of hyperkalemia (serum potassium greater than or equal to 5.5 mmol/L) in the past 6 months or serum potassium greater than or equal to 5.0 mmol/L within the past 2 weeks
  • Severe renal dysfunction, defined as an estimated glomerular filtration rate(GFR) less than 30 ml/min (per the Modification of Diet in Renal Disease (MDRD) 4-component study equation). Participants with serum creatinine greater than or equal to 2.5 mg/dl are also excluded even if their GFR is greater than or equal to 30 ml/min
  • Known chronic hepatic disease, defined as aspartate aminotransferase(AST) and alanine aminotransferase(ALT) levels greater than 3.0 times the upper limit of normal as read at the local lab
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00094302

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Cardiovascular Consultants, Ltd.
Glendale, Arizona, United States, 85306
Carl T. Hayden VA Medical Center
Phoenix, Arizona, United States, 85012
United States, Arkansas
Heart Clinic Arkansas
Little Rock, Arkansas, United States, 72205
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas, United States, 72205
United States, California
Cynthia Thaik
Burbank, California, United States, 91505
Fresno VA Medical Center
Fresno, California, United States, 93703
CAPRI
Los Angeles, California, United States, 90048
Clinica Medica San Miguel
Los Angeles, California, United States, 90015
VA Medical Center West Los Angeles
Los Angeles, California, United States, 90073
Mehrdad Kevin Ariani, MD, Inc.
Northridge, California, United States, 91325
UC Davis Medical Center
Sacremento, California, United States, 95829
Central Coast Cardiology
Salinas, California, United States, 93901
Naval Medical Center San Diego
San Diego, California, United States, 92134
Olive View - UCLA Medial Center
Sylmar, California, United States, 91342
United States, Colorado
University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045
Cardio-Vascular Institute
Greeley, Colorado, United States, 80631
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
United States, District of Columbia
Washington DC VA Hospital
Washington, District of Columbia, United States, 20422
Washington Hospital Center
Washington, District of Columbia, United States, 20010
Howard University Hospital
Washington DC, District of Columbia, United States, 20060`
United States, Florida
Daytona Heart Group
Daytona Beach, Florida, United States, 32114
M & O Clinical Research, LLC
Ft. Lauderdale, Florida, United States, 33316
Florida Heart Center
Ft. Pierce, Florida, United States, 34950
University of Florida
Gainesville, Florida, United States, 32610
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Brevard Cardiovascular Research Associates, Inc
Rockledge, Florida, United States, 37955
Tallahassee Research Institute
Tallahassee, Florida, United States, 32308
United States, Georgia
Northside Cardiology Center
Atlanta, Georgia, United States, 30342
Emory University at Grady Health System
Atlanta, Georgia, United States, 30303
Morehouse School of Medicine
Atlanta, Georgia, United States, 30310
InnovaMed Alliance
Marietta, Georgia, United States, 30060
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60657
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Illinois at Chicago Medical Center
Chicago, Illinois, United States, 60612
Cardiovascular Research Foundation
Elk Grove Village, Illinois, United States, 60007
Heart, Lung and Vascular Institute
Peoria, Illinois, United States, 61606
HeartCare Midwest
Peoria, Illinois, United States, 61614
United States, Indiana
The Care Group, LLC
Indianapolis, Indiana, United States, 46260
Cardiovascular Research of Northwest Indiana, LLC
Munster, Indiana, United States, 46321
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kentucky
Baptist Healthcare System, Inc. d/b/a Baptist Hospital East
Louisville, Kentucky, United States, 40207
United States, Louisiana
Leonard J. Chabert Medical Center
Houma, Louisiana, United States, 70363
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Maine
Northeast Cardiology
Bangor, Maine, United States, 04401
United States, Maryland
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Kaiser Permanente
Largo, Maryland, United States, 20774
Northwest Hospital
Randallstown, Maryland, United States, 21133
Delmarva Heart Research Foundation
Salisbury, Maryland, United States, 21804
Associates in Cardiology, PA
Silver Spring, Maryland, United States, 20910
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Merrimack Valley Cardiology Associates
Chelmsford, Massachusetts, United States, 01824
Compass Medical East Bridgewater
East Bridgewater, Massachusetts, United States, 02333
Pentucket Medical Associates
Haverhill, Massachusetts, United States, 01830
Charles River Medical Associates
Natick, Massachusetts, United States, 01760
Hawthorn Medical Associates
North Dartmouth, Massachusetts, United States, 02747
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
Umass Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Michigan
Veterans Affairs Ann Arbor Health Care System
Ann Arbor, Michigan, United States, 48105
Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48123
Detroit VA Medical Center
Detroit, Michigan, United States, 48201
Henry Ford Hospital
Detroit, Michigan, United States, 48202
William Beaumont Health Center
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Minneapolis VA Medical Center
Minneapolis, Minnesota, United States, 55417
United States, Missouri
Heartland Regional Medical Clinic
St. Joseph, Missouri, United States, 64506
United States, Montana
Glacier View Cardiology
Kalispell, Montana, United States, 59901
United States, Nebraska
Bryan LGH Heart Institute
Lincoln, Nebraska, United States, 68506
The Creighton Cardiac Center
Omaha, Nebraska, United States, 68131
United States, New Jersey
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States, 08015
Cardiovascular Associates of the Delaware Valley
Elmer, New Jersey, United States, 08318
Cardiovascular Associates of the Delaware Valley
Haddon Heights, New Jersey, United States, 08035
NJ Heart
Linden, New Jersey, United States, 07036
St. Joseph's Regional Medical Center
Paterson, New Jersey, United States, 07503
The Valley Hospital
Ridgewood, New Jersey, United States, 07450
Electrophysiology Research Foundation
Somerset, New Jersey, United States, 08873
Community Medical Center
Toms River, New Jersey, United States, 08755
New Jersey Cardiology Associates
West Orange, New Jersey, United States, 07052
United States, New York
Bronx-Lebanon Hospital Center
Bronx, New York, United States, 10457
New York Methodist Hospital
Brooklyn, New York, United States, 11215
Research Foundation State University of New York at Buffalo
Buffalo, New York, United States, 14203
Buffalo Heart Group, LLC
Buffalo, New York, United States, 14215
Jamaica Hospital Medical Center
Jamaica, New York, United States, 11418
Mid Valley Cardiology
Kingston, New York, United States, 12401
Winthrop Cardiology Associates
Mineola, New York, United States, 11501
Soundshore Medical Center of Westchester
New Rochelle, New York, United States, 10802
St. Lukes Roosevelt
New York, New York, United States, 10019
NYU School of Medicine
New York, New York, United States, 10016
Northport VA Medical Center
Northport, New York, United States, 11768
University of Rochester Medical Center
Rochester, New York, United States, 14618
Lewin, Fagen, and Lown, MD, PC
Smithtown, New York, United States, 11787
Syracuse VA Medical Center
Syracuse, New York, United States, 13210
SUNY Upstate Medical Center
Syracuse, New York, United States, 13210
United States, North Carolina
Northeast Medical Center
Concord, North Carolina, United States, 28025
Durham VA Medical Center
Durham, North Carolina, United States, 27705
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
The Lindner Clinical Trial Center
Cincinnati, Ohio, United States, 45219
University of Cincinnati
Cincinnati, Ohio, United States, 45267
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
University Hospitals of Cleveland/Case Western Reserve University
Cleveland, Ohio, United States, 44106
Ohio State University Hospital East
Columbus, Ohio, United States, 43205
VAMC Dayton
Dayton, Ohio, United States, 45428
CCHS Clinical Research Office/Marymount Hospital
Garfield Heights, Ohio, United States, 44125
CCHS Clinical Research Office/ Hillcrest Hospital
Mayfield Heights, Ohio, United States, 44124
United States, Oklahoma
Oklahoma City VA Medical Center
Oklahoma City, Oklahoma, United States, 73104
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma, United States, 73210
COR Clinical Research
Oklahoma City, Oklahoma, United States, 73103
Oklahoma Heart Institute
Tulsa, Oklahoma, United States, 74137
United States, Oregon
St. Charles Health System
Bend, Oregon, United States, 97701
Providence Heart and Vascular Institute
Portland, Oregon, United States, 97213
United States, Pennsylvania
Capital Area Research
Camp Hill, Pennsylvania, United States, 17011
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Medicor Associates, Inc
Erie, Pennsylvania, United States, 16507
The Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Lancaster Heart and Stroke Foundation
Lancaster, Pennsylvania, United States, 17603
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19102
Eastwick Primary Care
Philadelphia, Pennsylvania, United States, 19153
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Thomas Jefferson University Hospital- Dept. of Family and Community Health
Philadelphia, Pennsylvania, United States, 19107
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Pittsburgh VA Healthcare System
Pittsburgh, Pennsylvania, United States, 15240
The Reading Hospital and Medical Center
West Reading, Pennsylvania, United States, 19611
United States, Rhode Island
Memorial Hospital Rhode Island
Pawtucket, Rhode Island, United States, 02860
United States, South Carolina
VAMC - Charleston, SC
Charleston, South Carolina, United States, 29401
United States, South Dakota
Black Hills VA Health Care System
Ft. Meade, South Dakota, United States, 57741
United States, Tennessee
The Stern Cardiovascular Center
Germantown, Tennessee, United States, 38138
Memphis Heart Clinic
Memphis, Tennessee, United States, 38120
Memphis VA Medical Center
Memphis, Tennessee, United States, 38104
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38163
Vanderbilt Heart and Vascular Institute
Nashville, Tennessee, United States, 37232
United States, Texas
DCT - APHC, LLC dba Discovery Clinical Trials
Arlington, Texas, United States, 76014
Cardiovascular Research Institute of Dallas
Dallas, Texas, United States, 75231
Dallas VA Medical Center
Dallas, Texas, United States, 75216
U.T. Southwestern Medical Center
Dallas, Texas, United States, 75390
Michael E. DeBakey VA Medical Cntr.
Houston, Texas, United States, 77030
The Methodist Hospital Research Institute
Houston, Texas, United States, 77030
Wilford Hall Medical Center
Lackland, Texas, United States, 78236
Texas Tech University Health Sciences Center
Odessa, Texas, United States, 79763
Cardiology Clinic of San Antonio
San Antonio, Texas, United States, 78229
Tyler Cardiovascular Consultants
Tyler, Texas, United States, 75701
United States, Utah
LDS Hospital
Murray, Utah, United States, 84157
University of Utah
Salt Lake City, Utah, United States, 84132
United States, Virginia
Cardiovascular Associates Ltd.
Chesapeake, Virginia, United States, 23320
Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States, 23507
United States, Washington
Evergreen Healthcare
Kirkland, Washington, United States, 98034
Providence St. Peter Hospital
Olympia, Washington, United States, 98506
Sound Health Research
Port Orchard, Washington, United States, 98366
University of Washington
Seattle, Washington, United States, 98195
United States, West Virginia
CAMC Health Education and Research Institute
Charleston, West Virginia, United States, 25304
United States, Wisconsin
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53792
William S. Middleton Memorial VA Hospital
Madison, Wisconsin, United States, 53705
Aspirus Heart and Vascular Institute
Wausau, Wisconsin, United States, 54401
Argentina
Instituto de Investigaciones Clinicas de Bahia Blanca
Bahia Blanca, Buenos Aires, Argentina, B80001JH
Clinica Coronel Suarez
Coronel Suarez, Buenos Aires, Argentina, b7540ghd
Hospital Italiano de La Plata
La Plata, Buenos Aires, Argentina, B1900 AXI
Instituto de Investigaciones Clinicas de Mar Del Plata
Mar del Plata, Buenos Aires, Argentina, B7600 FZN
Instituto de Investigaciones Clinicas de Quilmes
Quilmes, Buenos Aires, Argentina, 1878
Policlinico Modelo de Cipoletti
Cipolletti, Rio Negro, Argentina, 8324
Instituto Cardiologico Ezpecializado S.R.L
Buenos Aires, Argentina, C1426 ANZ
Clinica IMA
Buenos Aires, Argentina, J846
IMAI Research
Buenos Aires, Argentina, 1425
CIPREC
Buenos Aires, Argentina, C1119ACN
Clinica Privada Del Prado
Cordoba, Argentina, X500AAW
Instituto de Investigaciones Clinicas de Rosario
Rosario Santa Fe, Argentina, 2000
Hospital San Bernardo
Salta, Argentina, A4406CLA
Centro de Investigaciones Clinicas del Litoral SRL
Santa Fe, Argentina, 3000
Sanatorio Mayo S.A.
Santa Fe, Argentina
Centro Modelo de Cardiología
Tucuman, Argentina
Centro Privado de Cardiologia
Tucuman, Argentina, T4000NIL
Instituto de Cardiologia SRL
Tucuman, Argentina
Brazil
Hospital Felicio Rocho
Belo Horizonte, Brazil
Santa Casa De Belo Horizonte
Belo Horizonte, Brazil
HMCP PUC Campinas
Campinas, Brazil
Irmandade da Santa Casa de Misericordia de Curitiba
Curitiba Parana, Brazil
Hospital das Clinicas da Universidade Federal de Goias
Goias, Brazil
Instituto do Coracao de Marilia
Marilia Sao Paulo, Brazil
Hospital Sao Vicente de Paulo
Passo Fundo, Brazil
PROCAPE
Pernambuco, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Brazil, 90035-903
Hospital Mae De Deus
Porto Alegre, Brazil
Hospital Universitario Pedro Ernesto
Rio de Janeiro, Brazil
Santa Casa de Misericordia do Rio de Janeiro
Rio de Janeiro, Brazil
Instituto de Molestias Cardiosvaculares
San Paulo, Brazil
Instituto de Cardiologia de Santa Catarina
Santa Catarina, Brazil
Incor Fmusp
Sao Paulo, Brazil
UNIFESP/Hospital Sao Paulo
Sao Paulo, Brazil
Instituto do Coracao do Triangulo Mineiro
Uberlandia, Brazil
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 4N1
Canada, British Columbia
Fraser Clinical Trials Inc.
New Westminster, British Columbia, Canada, V3L 3W4
Canada, Manitoba
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H2A6
Canada, Newfoundland and Labrador
Health Science Centre
St. John's, Newfoundland and Labrador, Canada, AIB 3V6
Canada, Nova Scotia
Capital District Health Authority
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Dr. Saul Vizel Cardiac Research Office
Cambridge, Ontario, Canada, N1R 7R1
Cornwall Clinical Trials
Cornwall, Ontario, Canada, K6H 4M4
Hamilton Health Sciences - General Site
Hamilton, Ontario, Canada, L8L 2X2
London Health Sciences Center
London, Ontario, Canada, N6A 5A5
Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Dr. Gurcharan Syan (PP)
Sudbury, Ontario, Canada, P3C 5K7
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
CHUS - Hopital Fleurimont
Fleurimont, Quebec, Canada, J1H 5N4
Service de la Recherche
Granby, Quebec, Canada, J2G 1T7
Cite de la Sante de Laval
Laval, Quebec, Canada, H7M 3L9
Clinique Cardiologie Levis
Levis, Quebec, Canada, G6V 4Z5
CHUM - Hotel Dieu
Montreal, Quebec, Canada, H2W 1T8
Chum Hotel Dieu
Montreal, Quebec, Canada, H2W IT8
Hopital Du Sacre Coeur de Montreal
Montreal, Quebec, Canada, A4J 1C5
Montreal General Hospital
Montreal, Quebec, Canada, H3G IA4
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
Centre de recherche clinique de Quebec
Quebec City, Quebec, Canada, G1J 1Z6
Centre Hosp Regional de Lanaudiere
Sainte Charles Borromee, Quebec, Canada, J6E 6J2
C.S.S.S.B.
St. George, Quebec, Canada, G5Y 4T8
Hopital Laval
Ste-Foy, Quebec, Canada, GIV 4G5
CSSS du Sud de Lanaudiere (Hopital Pierre-Le Gardeur)
Terrebonne, Quebec, Canada, J6V 2H2
Centre De Sante et De Services Sociaux De Thetford
Thetford-Mines, Quebec, Canada, G6G 2V4
Canada
Misericordia Hospital - Cardiac Sciences
Edmonton, Canada
CDRC Rive-Sud
Longueuil, Canada
SMBD Jewish General Hospital
Montreal, Canada
Saskatchewan Heart Centre
Saskatoon, Canada
Cardiology Clinical Trials - Surrey Memorial Hospital
Surrey, Canada
Centre Hospitalier de Trois-Rivieres
Trois Rivieres, Canada
Georgia
L &J Clinic
Kutaisi, Georgia, 4600
Cardio-Reanimation Centre
Tbilisi, Georgia, 0141
Clinic of Angiocardiology "ADAPTI"
Tbilisi, Georgia, 0186
Diagnostic Services Clinic
Tbilisi, Georgia, 0179
Emergency Cardiology Centre
Tbilisi, Georgia, 0159
Multiprofile Clinical Hospital of Tbilisi #2
Tbilisi, Georgia, 0154
National Center of Therapy
Tbilisi, Georgia, 0159
Tbilisi State Medical University Clinic #1
Tbilisi, Georgia, 0102
Cardiology Clinic
Tibilisi, Georgia, 0144
Russian Federation
Municipal Healthcare Institution <>
Gatchina, Leningrad Region, Russian Federation, 188300
Altay State Medical University of federal agency of public health and social progress RF
Barnaul, Russian Federation, 656038
Municipal Health Care Institution "City Hospital #1"
Barnaul, Russian Federation, 656099
Kaliningrad Region Hospital
Kaliningrad, Russian Federation, 236016
Kemerovo Cadiologiy Dispensary, Kemerovo Medical Academy
Kemerovo, Russian Federation, 650002
Nonstate Healthcare Institution
Kemerovo, Russian Federation, 650036
State Healthcare Institution "Region Clinical Hospital #1
Krasnodar, Russian Federation, 350086
Federal State Institution "Outpatient clinic #3 of President's Management Department of Russian Fede
Moscow, Russian Federation, 129090
National Research Center for Preventitive Medicine
Moscow, Russian Federation, 101990
Non State Health Care Institution Central Hospital #6 of Russian Railways JSC
Moscow, Russian Federation
Research Institute of Physico-Chemical Medicine Center for Atheosclerosis and Laboratory
Moscow, Russian Federation, 777020
Russian State Medical University, Hospital Therapy Department #1
Moscow, Russian Federation, 111539
State Education High Professional Education Russian State Medical University
Moscow, Russian Federation, 115093
Novosibirsk Municipal Clinical Emergency Hosp. # 2
Novosibirsk, Russian Federation, 630008
Chair of Nephrology and Dialysis of St Petersburg State Medical University
Saint Petersburg, Russian Federation
Saint-Petersburg State Healthcare Institution "City Alexander's Hospital"
Saint Petersburg, Russian Federation, 193312
Saint-Petersburg State Institution of Health Protection, "City Hosptial # 15"
Saint Petersburg, Russian Federation, 198205
Federal State Health Care Institution
Saint-Petersburg, Russian Federation, 194291
Medico- Military Academy, Navy Therapy Dept
Saint-Petersburg, Russian Federation, 198013
Saint-Petersburg State Health Institution "Pokrovskaya City Hospital"
Saint-Petersburg, Russian Federation, 199106
Public Institution of Health City Hospital # 28
Saint-Petersburg, Russian Federation, 190000
Federal State Institution
Saratov, Russian Federation, 410028
State Educational Institution of High Professional Education Saratov State Medical University
Saratov, Russian Federation, 410054
Almasov research institute of Cardiology
St. Petersberg, Russian Federation, 194156
Chair and Department of Hospital Therapy
St. Petersburg, Russian Federation, 197089
City Hospital #26
St. Petersburg, Russian Federation, 196247
City Hospital No 26
St. Petersburg, Russian Federation, 196247
Non-state Health Care Institution
St. Petersburg, Russian Federation, 195221
Saint-Petersburg Clinical Hospital of RAMS, policlinic department
St. Petersburg, Russian Federation, 194017
Saint-Petersburg State Health Care Institution "City Hospital of Saint George the Martyr"
St. Petersburg, Russian Federation, 194354
State Institution Saint-Petersburg Dzhanelidze Scientific
St. Petersburg, Russian Federation, 192242
State Institition Research Institution of Cardiology of Tomsk
Tomsk, Russian Federation, 634012
State Educational institution of Higher Professional Education "Volgograd State Medical University o
Volgograd, Russian Federation, 400001
State Health Care Institution "Voronezh Regional Clinical Consultative & Diagnostic Centre"
Voronezh, Russian Federation, 396018
City Healthcare Institution Clinical Hospital #8
Yaroslavl, Russian Federation, 150030
Yaroslavl Regional Clinical Hospital
Yaroslavl, Russian Federation, 150068
Sponsors and Collaborators
New England Research Institutes
Investigators
Principal Investigator: Sonja M. McKinlay, PhD New England Research Institutes, Inc.
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: New England Research Institutes
ClinicalTrials.gov Identifier: NCT00094302     History of Changes
Other Study ID Numbers: 160, HHSN268200425207C
Study First Received: October 15, 2004
Last Updated: November 29, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by New England Research Institutes:
Heart Failure
Diastolic Heart Failure
Preserved Ejection Fraction

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Heart Failure
Mineralocorticoid Receptor Antagonists
Spironolactone
Cardiovascular Agents
Diuretics
Diuretics, Potassium Sparing
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014