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The DIAMOND Study: Distensibility Improvement And Remodeling in Diastolic Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00043836
Recruitment Status : Completed
First Posted : August 15, 2002
Last Update Posted : September 2, 2009
Information provided by:
Synvista Therapeutics, Inc

Brief Summary:
The purpose of this study is to test the hypothesis that treatment with oral ALT-711 twice daily for 16 weeks will improve aortic distensibility, exercise tolerance, and quality of life in elderly patients with isolated diastolic heart failure (DHF), and that the improvements in exercise tolerance will correlate with the improvements in aortic distensibility.

Condition or disease Intervention/treatment Phase
Heart Failure, Congestive Dyspnea Pulmonary Edema Drug: ALT-711 Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study Of ALT-711 In Elderly Patients With Isolated Diastolic Heart Failure: The DIAMOND Study
Study Start Date : July 2002
Actual Primary Completion Date : February 2003
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  1. Men or women ≥ 60 years of age.
  2. Diagnosis of congestive heart failure with one or both of the following criteria: a Heart Failure Clinical Score ≥ 3 based on the NHANES-I criteria and/or a history of either acute pulmonary edema or the occurrence of 2 or more of the following with subsequent improvement with diuretic therapy and with no other identifiable cause: dyspnea on exertion, paroxysmal nocturnal dyspnea, orthopnea, systemic edema, exertional fatigue.
  3. Left ventricular ejection fraction ≥ 50% based on the baseline Doppler echocardiography test.
  4. Ability to provide written informed consent.
  5. Ability to comply with procedures specified in the study protocol.

Exclusion Criteria

  1. Valvular heart disease as the primary etiology of congestive heart failure.
  2. Significant change in cardiovascular medication(s) <3 weeks prior to the baseline visit.
  3. Uncontrolled hypertension.
  4. History of stroke, or any sequelae of a transient ischemic attack (TIA), reversible ischemic neurologic defect (RIND), or stroke, within the last 12 months prior to entry into the study.
  5. Cancer or other noncardiovascular conditions with life expectancy less than 2 years.
  6. Significant anemia defined as a hemoglobin <11 gm/dL.
  7. Significant renal insufficiency defined as a serum creatinine >2.5 mg/dL.
  8. Significant hepatic insufficiency defined as an SGPT (ALT) or SGOT (AST) >2.5 times the upper limit of normal.
  9. Psychiatric disease (including uncontrolled major psychoses, depression, dementia, or personality disorder) or any additional condition(s) which, in the investigator's opinion, would prohibit the patient from completing the study, or not be in the best interest of the patient.
  10. Presence or history of drug or alcohol abuse.
  11. Prior exposure to ALT-711 or use of any other investigational drugs within 30 days prior to screening.
  12. Known seropositivity for HIV or hepatitis C, or presence of hepatitis B surface antigen.
  13. Severe COPD requiring recurrent oral steroids, oxygen at home or more than one inhaler.
  14. Baseline echocardiogram demonstrating the presence of left ventricular ejection fraction <50%.
  15. Unstable or uncontrolled myocardial ischemia, with no wall abnormality.
  16. Screening Familiarization Exercise Test demonstrating the presence of any of the following findings: evidence of significant ischemia (consisting of ECG finding of > 1 mm flat ST depression confirmed with echocardiogram wall motion, or wall motion abnormality or decrease in global contractility on echocardiogram, or inability to continue exercising due to significant chest or leg pain or any reason other than exhaustion/fatigue/dyspnea, exercise SBP >240 mm Hg, DBP >110 mmHg, unstable hemodynamics or rhythm, or unwilling or unable to complete test adequately.
  17. Any contraindications to magnetic resonance imaging including but not limited to indwelling metal-containing prosthesis (orthopedic, valvular, other), pacemaker or defibrillator, history of welding occupation (ocular metal debris), or uncontrollable claustrophobia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00043836

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United States, North Carolina
Wake Forest University Baptist Medical Center, Department of Cardiology
Winston-Salem, North Carolina, United States, 27157-1045
United States, South Carolina
Medical University of South Carolina and Ralph H. Johnson VA Medical Center
Charleston, South Carolina, United States, 29425 and 29401
Sponsors and Collaborators
Synvista Therapeutics, Inc
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Principal Investigator: Dalane W Kitzman, MD Associate Professor of Medicine and Cardiology, Wake Forest University Baptist Medical Center
Principal Investigator: Michael R Zile, MD Charles Ezra Daniel Professor of Medicine, Medical University of South Carolina

Layout table for additonal information Identifier: NCT00043836    
Other Study ID Numbers: ALT-711-0214
First Posted: August 15, 2002    Key Record Dates
Last Update Posted: September 2, 2009
Last Verified: August 2007
Keywords provided by Synvista Therapeutics, Inc:
ejection fraction
exercise tolerance
heart failure, congestive
quality of life
Additional relevant MeSH terms:
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Pulmonary Edema
Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Lung Diseases