Effect of Aldosterone on Energy Starvation in Heart Failure
This trial is active, not recruiting.
|Conditions||heart failure, nonischemic dilated cardiomyopathy|
|Sponsor||Vanderbilt University Medical Center|
|Start date||December 2007|
|End date||July 2018|
|Trial size||20 participants|
|Trial identifier||NCT00574119, IRB 070824|
We plan to study the concept of "energy starvation" in heart failure by evaluation of patients with nonischemic dilated cardiomyopathy (NIDCM) (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).
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
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
quality of life questionnaire, 6 minute walk test
time frame: 6 mnths
Male or female participants at least 18 years old.
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.
|Official title||Effect of Aldosterone on Energy Starvation in Heart Failure|
|Principal investigator||Marvin W Kronenberg, MD|
|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.|
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