Novel Treatment for Diastolic Heart Failure in Women

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Treatments: Spironolactone

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.