Novel Treatment for Diastolic Heart Failure in Women

Completed · Phase 4 · Has a placebo group

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT00206232

Run by

Baylor College of Medicine

People needed

48

Starts

2004-07-01

Expected to finish

2010-07-01

Last updated by the study team

2013-02-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Baylor College of Medicine Heart Clinic — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.