PIE II: Pharmacological Intervention in the Elderly II

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.

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)