Status:
COMPLETED
Novel Treatment for Diastolic Heart Failure in Women
Lead Sponsor:
Baylor College of Medicine
Conditions:
Heart Failure
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief 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 spironola...
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 place...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00206232
Start Date
July 1 2004
End Date
July 1 2010
Last Update
February 18 2013
Active Locations (1)
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1
Baylor College of Medicine Heart Clinic
Houston, Texas, United States, 77030