PIE II: Pharmacological Intervention in the Elderly II

Wake Forest University (WFU)

Status and phase

Completed

Phase 3

Conditions

Diastolic Heart Failure

Heart Failure, Congestive

Treatments

Drug: Placebo

Drug: Spironolactone

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00123955

AG0030

R01AG018915 (U.S. NIH Grant/Contract)

2R01AG018915-05 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full description

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.

Enrollment

80 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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)