Effect of Aldosterone on Energy Starvation in Heart Failure
We plan to study the concept of "energy starvation" in heart failure by evaluation of patients with nonischemic dilated cardiomyopathy (heart failure with reduced heart pump function due to causes other than heart attack). We will use a combination of positron emission tomography and magnetic resonance imaging to study metabolism, anatomy, function, blood flow and efficiency, before and after 6...
Brief Summary
Official Title: “Effect of Aldosterone on Energy Starvation in Heart Failure”
We plan to study the concept of "energy starvation" in heart failure by evaluation of patients with nonischemic dilated cardiomyopathy (heart failure with reduced heart pump function due to causes other than heart attack). We will use a combination of positron emission tomography and magnetic resonance imaging to study metabolism, anatomy, function, blood flow and efficiency, before and after 6 months' treatment with the drug spironolactone which blocks the deleterious effects of the hormone aldosterone on the myocardium (heart muscle).
- Study Type: Interventional
- Study Design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
- Study Primary Completion Date: July 2011
Detailed Clinical Trial Description
Preliminary results showed reduced subendocardial myocardial perfusion reserve in NIDCM compared to normal subjects, and that the degree of impaired perfusion reserve was related to the oxidative metabolic rate as measured by positron emission tomography.
Intervention(s) in this Clinical Trial
- Drug: spironolactone
- spironolactone 50 mg daily for 6 months
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: A
- patients with heart failure due to nonischemic dilated cardiomyopathy will be studied by positron emission tomography and magnetic resonance imaging before and after 6 months' treatment with spironolactone.
Outcome Measures for this Clinical Trial
Primary Measures
- left ventricular work-metabolic index, myocardial blood flow by magnetic resonance imaging, subendocardial hypoxia by magnetic resonance imaging, myocardial fibrosis by magnetic resonance imaging
- Time Frame: 6 months
Safety Issue?: No
- Time Frame: 6 months
Secondary Measures
- quality of life questionnaire, 6 minute walk test
- Time Frame: 6 mnths
Safety Issue?: No
- Time Frame: 6 mnths
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- 18 years or older
- Nonischemic dilated cardiomyopathy
- Left ventricular ejection fraction 35% or less
- Stable heart failure symptoms
- Able to undergo both positron emission tomography and magnetic resonance imaging with gadolinium
- Able to tolerate treatment with spironolactone
Exclusion Criteria:
- Serum potassium >5.0
- Serum creatinine >2.5
- Contraindications to magnetic resonance imaging such as internal cardioverter-defibrillator.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Vanderbilt University Other
Overall Clinical Trial Officials and Contacts
Marvin W Kronenberg, MD Principal Investigator Vanderbilt University School of Medicine
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00574119
Study ID Number: IRB 070824
ClinicalTrials.gov Identifier: NCT00574119
Health Authority: United States: Institutional Review Board
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00574119
