PIE II: Pharmacological Intervention in the Elderly II
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)...
Brief Summary
Official Title: “Exercise Intolerance in Elderly Diastolic Heart Failure”
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).
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
- Study Primary Completion Date: June 2009
Detailed Clinical Trial 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, 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.
Intervention(s) in this Clinical Trial
- Drug: Spironolactone
- 25mg tablet daily for 9 months
- Drug: Placebo
- Placebo tablet daily for 9 months
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Spironolactone
- Placebo Comparator: 2
- Placebo
Outcome Measures for this Clinical Trial
Primary Measures
- Exercise intolerance
- Time Frame: Baseline, 4 and 9 months
Safety Issue?: No
- Time Frame: Baseline, 4 and 9 months
- quality of life
- Time Frame: Baseline, 4 and 9 months
Safety Issue?: No
- Time Frame: Baseline, 4 and 9 months
Secondary Measures
- Concentric left ventricular remodeling
- Time Frame: Baseline, 4 and 9 months
Safety Issue?: No
- Time Frame: Baseline, 4 and 9 months
- left ventricular diastolic stiffness
- Time Frame: Baseline, 4 and 9 months
Safety Issue?: No
- Time Frame: Baseline, 4 and 9 months
Criteria for Participation in this Clinical Trial
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)
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 60 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Wake Forest University Other
Overall Clinical Trial Officials and Contacts
Dalane W. Kitzman, MD Principal Investigator Professor of Internal Medicine, Cardiology, Director of Echocardiography, Wake Forest University Health Sciences
Related Publications
References
Kitzman DW, Little WC, Brubaker PH, Anderson RT, Hundley WG, Marburger CT, Brosnihan B, Morgan TM, Stewart KP. Pathophysiological characterization of isolated diastolic heart failure in comparison to systolic heart failure. JAMA. 2002 Nov 6;288(17):2144-50.
Kitzman DW, Higginbotham MB, Cobb FR, Sheikh KH, Sullivan MJ. Exercise intolerance in patients with heart failure and preserved left ventricular systolic function: failure of the Frank-Starling mechanism. J Am Coll Cardiol. 1991 Apr;17(5):1065-72.
Kitzman DW, Gardin JM, Gottdiener JS, Arnold A, Boineau R, Aurigemma G, Marino EK, Lyles M, Cushman M, Enright PL. Importance of heart failure with preserved systolic function in patients > or = 65 years of age. CHS Research Group. Cardiovascular Health Study. Am J Cardiol. 2001 Feb 15;87(4):413-9.
Zannad F, Alla F, Dousset B, Perez A, Pitt B. Limitation of excessive extracellular matrix turnover may contribute to survival benefit of spironolactone therapy in patients with congestive heart failure: insights from the randomized aldactone evaluation study (RALES). Rales Investigators. Circulation. 2000 Nov 28;102(22):2700-6. Erratum in: Circulation 2001 Jan 23;103(3):476.
Pitt B, Zannad F, Remme WJ, Cody R, Castaigne A, Perez A, Palensky J, Wittes J. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators. N Engl J Med. 1999 Sep 2;341(10):709-17.
Cicoira M, Zanolla L, Franceschini L, Rossi A, Golia G, Zeni P, Caruso B, Zardini P. Relation of aldosterone "escape" despite angiotensin-converting enzyme inhibitor administration to impaired exercise capacity in chronic congestive heart failure secondary to ischemic or idiopathic dilated cardiomyopathy. Am J Cardiol. 2002 Feb 15;89(4):403-7.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00123955
Study ID Number: AG0030
ClinicalTrials.gov Identifier: NCT00123955
Health Authority: United States: Federal Government
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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00123955
