PIE II: Pharmacological Intervention in the Elderly II

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest School of Medicine; Wake Forest University
• Collaborator: National Institute on Aging (NIA)
• Treatments: Spironolactone

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)