Novel Treatment for Diastolic Heart Failure in Women
Heart Failure
About this trial
This is an interventional diagnostic trial for Heart Failure focused on measuring Diastolic Heart Failure
Eligibility 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.
Sites / Locations
- Baylor College of Medicine Heart Clinic
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Spironolactone
Placebo
Randomized, double-blind, placebo controlled trial evaluating the safety and efficacy of spironolactone 25mg daily for 6 months.
Randomized, double-blind, placebo controlled trial evaluating the safety and efficacy of spironolactone 25mg daily for 6 months.