Not Signed In -
Spironolactone |
Aldactone |
Clinical Trial: PIE II: Pharmacological Intervention in the Elderly II
This study is currently recruiting patients.
|
Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Diastolic Heart Failure | Drug: Spironolactone | Phase III |
MedlinePlus related topics: Cardiomyopathy
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Exercise Intolerance in Elderly Diastolic Heart Failure
Secondary Outcomes: Concentric left ventricular remodeling; left ventricular diastolic stiffness; serum markers of myocardial fibrosis
Expected Total Enrollment: 72
Study start: April 2005
Exercise intolerance due to diastolic heart failure (DHF) is a major cause of disability among older Americans. Several lines of evidence suggest that aldosterone antagonism may improve exercise intolerance in DHF. Spironolactone is a generic, inexpensive aldosterone antagonist. In an open-label pilot study of spironoloactone in 10 elderly patients with isolated DHF there were significant improvements in exercise intolerance, quality of life, and left ventricular (LV) diastolic stiffness. 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 DHF. The secondary aim is to determine whether the improvements in exercise tolerance are related to improvements in abnormal concentric LV remodeling, LV diastolic stiffness, and myocardial fibrosis. These results will be important, not only because diastolic heart failure is highly prevalent among the elderly, but also because exercise intolerance is a pivotal outcome that is modifiable, is independent of mortality, and is a critical determinant of quality of life and disability among the elderly.
A total of 72 participants aged 60 or older will be randomized to receive either Spironolactone 25mg daily or a placebo. There will be 9 visits over the 9-month trial period. Three testing visits will last approximately 2 hours each, and 6 follow-up visits will each last approximately 30 minutes.
Eligibility
Inclusion Criteria:
- Ambulatory
- Medically stable
- Age 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, depressions, 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, exercise
- Contra-indications to MRI--indwelling metal-containing prosthesis; pacemaker or defibrillator; history of welding occupation; uncontrollable claustrophobia
Location and Contact Information
Dalane W. Kitzman, MD 336-716-3274 dkitzman@wfubmc.edu
North Carolina
Wake Forest University Baptist Medical Center, Winston Salem, North Carolina, 27157, United States; Recruiting
Judy D. Brown 336-713-4702
Dalane W. Kitzman, MD, Principal Investigator, Professor of Internal Medicine, Cardiology, Director of Echocardiography, Wake Forest University Health Sciences
More Information
Publications
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.
Record last reviewed: July 2005
Last Updated: July 25, 2005
Record first received: July 25, 2005
ClinicalTrials.gov Identifier: NCT00123955
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-26
Resources
- Aldactone (Drug Digest)
- Spironolactone (Drug Digest)
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