Status:
COMPLETED
PIE II: Pharmacological Intervention in the Elderly II
Lead Sponsor:
Wake Forest University
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Diastolic Heart Failure
Heart Failure, Congestive
Eligibility:
All Genders
60+ years
Phase:
PHASE3
Brief 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).
Detailed 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...
Eligibility Criteria
Inclusion
- Ambulatory
- Medically stable
- Ages 60 or older
- Diagnosis of diastolic heart failure
Exclusion
- 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)
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00123955
Start Date
April 1 2005
End Date
December 1 2012
Last Update
February 27 2019
Active Locations (1)
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1
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157