Novel Treatment for Diastolic Heart Failure in Women - Full Text View

Purpose

The purpose of the study is to collect information about the potential benefit and safety of low dose spironolactone for a patient with diastolic heart failure (DHF) and to determine whether spironolactone can cause the patient's condition to improve.

Condition	Intervention	Phase
Heart Failure	Drug: Spironolactone	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Diagnostic
Official Title:	Novel Treatment for Diastolic Heart Failure in Women

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: Spironolactone

U.S. FDA Resources

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:

Six minute walk distance [ Time Frame: Baseline, then 3 and 6 months after randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Echocardiography parameters of diastolic function [ Time Frame: Baseline, then 3 and 6 months after randomization ] [ Designated as safety issue: No ]

Other Outcome Measures:

Procollagen peptides, troponin I, tumor necrosis factor alpha, Brain Natriuretic Peptide [ Time Frame: Baseline then 3 and 6 months after randomization ] [ Designated as safety issue: No ]
Electrolytes, blood urea nitrogen, creatinine [ Time Frame: Screening and enrollment then 10 days, 4 weeks, 11 weeks, 13 weeks, and 15 weeks after randomization ] [ Designated as safety issue: Yes ]
Quality of Life Questionaire [ Time Frame: Baseline, then 3 and 6 months after randomization ] [ Designated as safety issue: No ]
New York Heart Association Classification [ Time Frame: Baseline then 3 and 6 months after randomization ] [ Designated as safety issue: No ]
Number of participants with adverse events [ Time Frame: From randomization until trial completion at 6 months. ] [ Designated as safety issue: Yes ]

Enrollment:	48
Study Start Date:	July 2004
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Spironolactone Randomized, double-blind, placebo controlled trial evaluating the safety and efficacy of spironolactone 25mg daily for 6 months.	Drug: Spironolactone Research subjects are randomized to placebo versus spironolactone 25mg daily and followed for 6 months. Other Name: Aldactone
Placebo Comparator: Placebo Randomized, double-blind, placebo controlled trial evaluating the safety and efficacy of spironolactone 25mg daily for 6 months.	Drug: Spironolactone Research subjects are randomized to placebo versus spironolactone 25mg daily and followed for 6 months. Other Name: Aldactone

Detailed Description:

Subjects with diastolic heart failure defined based on clinical symptoms, echocardiography diastology parameters and brain natriuretic peptide level will be randomized in a 1:1 fashion to either placebo or spironolactone 25mg daily for 6 months. They will be assessed over this 6 month period for improvement in exercise capacity, clinical symptoms, echocardiography diastology parameters, and biomarkers specific for heart failure. Safety of spironolactone in this patient population will also be assessed by recording adverse events and following electrolytes, blood urea nitrogen, and creatinine levels.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Women who are 18 years of age or older.
Women with clinical heart failure for > 2 months.
Women with left ventricular ejection fraction > 50% within 2 months of screening.
Women with New York Heart Association class II or III heart failure symptoms.
Brain Natriuretic Peptide > 62 pg/ml within 2 months of screening.
Patient on angiotensin converting enzyme inhibitor or angiotensin receptor blocker therapy for at least 1 month.
Blood Pressure no more than 150/95.
Patient able to walk more than 50 meters at the time of enrollment.
Signed informed consent.

Exclusion Criteria:

Current treatment with spironolactone.
Severe hepatic impairment.
Creatinine > 2.5 mg/dl
Potassium > 5.0 mEq/L
Intolerance to spironolactone in the past.
Significant valvular heart disease, pericardial disease, or severe chronic lung disease with cor pulmonale.
Unstable angina or myocardial infarction within the past 4 weeks.
Severe peripheral vascular disease or other physical conditions that would limit the walking distance.
Pregnant or lactating females.
Participation in any other drug trial within 30 days prior to randomization.
Inability to provide informed consent.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206232

Locations

United States, Texas
Baylor College of Medicine Heart Clinic
Houston, Texas, United States, 77030

Sponsors and Collaborators

Baylor College of Medicine

Investigators

Principal Investigator:

Karla M Kurrelmeyer, MD

Baylor College of Medicine

More Information

No publications provided

Responsible Party:	Karla Kurrelmeyer, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00206232 History of Changes
Other Study ID Numbers:	H - 13988
Study First Received:	September 12, 2005
Last Updated:	February 15, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:

Diastolic Heart Failure

Additional relevant MeSH terms:

Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases
Spironolactone
Aldosterone Antagonists
Hormone Antagonists

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013