PIE II: Pharmacological Intervention in the Elderly II

Completed · Phase 3 · Has a placebo group

Conditions studied: Diastolic Heart Failure, Heart Failure, Congestive

In brief

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).

Key facts

Study ID

NCT00123955

Run by

Wake Forest University

People needed

80

Starts

2005-04-01

Expected to finish

2012-12-01

Last updated by the study team

2019-02-27

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ambulatory
• Medically stable
• Ages 60 or older
• Diagnosis of diastolic heart failure

You may not qualify if…

• 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)

Where it is running

• Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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