Phase 3
N=80
PIE II: Pharmacological Intervention in the Elderly II
Diastolic Heart Failure · Heart Failure, Congestive
Bottom Line
View on ClinicalTrials.gov: NCT00123955 ↗Enrolled (actual)
80
Serious AEs
15.0%
Results posted
Feb 2015
Primary outcome: Primary: Exercise Intolerance — 13.5; 13.3; 13.6; 13.5 ml/kg/min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Spironolactone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Wake Forest University
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Exercise Intolerance |
13.5; 13.3; 13.6; 13.5; 13.8; 13.9 | — |
| PRIMARY Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire-total Score |
32; 28; 29; 29; 29; 25 | — |
| SECONDARY Concentric Left Ventricular Remodeling |
1.8; 1.7; 1.7; 1.6 | — |
| SECONDARY Left Ventricular Diastolic Stiffness |
7.0; 6.8; 7.0; 6.8; 7.4; 6.6 | — |
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).
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT00123955). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.