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Winston-Salem, North Carolina 27157


Purpose:

The purpose of this study is to examine whether spironolactone will improve exercise tolerance and quality of life in elderly patients with heart failure preserved ejection fraction (HFPEF).


Study summary:

Exercise intolerance due to HFPEF is a major cause of disability among older Americans. Several lines of evidence suggest that aldosterone antagonism may improve exercise tolerance in HFPEF. Therefore, the primary aim of this study is to test the hypothesis that spironolactone will improve exercise tolerance and quality of life in elderly patients with isolated HFPEF. A total of 72 participants aged 60 or older will be randomized to receive either spironolactone 25mg daily or a placebo.


Criteria:

Inclusion Criteria: - Ambulatory - Medically stable - Ages 60 or older - Diagnosis of diastolic heart failure Exclusion Criteria: - Valvular heart disease - Significant change in cardiac medication within the past 4 weeks - Uncontrolled hypertension - Recent or debilitating stroke - Cancer or other noncardiovascular conditions with life expectancy less than 2 years - Anemia - Elevated serum potassium - Renal insufficiency - Psychiatric disease (uncontrolled major psychoses, depression, dementia, or personality disorder) - Allergy to spironolactone; currently taking spironolactone or any aldosterone antagonist - Plans to leave area within 1 year - Refuses informed consent - Failure to pass screening tests: pulmonary function, echocardiogram, or exercise - Contra-indications to magnetic resonance imaging [MRI] (indwelling metal-containing prosthesis; pacemaker or defibrillator; history of welding occupation; uncontrollable claustrophobia)


NCT ID:

NCT00123955


Primary Contact:

Principal Investigator
Dalane W. Kitzman, MD
Professor of Internal Medicine, Cardiology, Director of Echocardiography, Wake Forest University Hea


Backup Contact:

N/A


Location Contact:

Winston-Salem, North Carolina 27157
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 11, 2017

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