Overview

This trial is active, not recruiting.

Conditions heart failure, nonischemic dilated cardiomyopathy
Treatment spironolactone
Phase phase 4
Sponsor Vanderbilt University
Start date December 2007
End date July 2016
Trial size 20 participants
Trial identifier NCT00574119, IRB 070824

Summary

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
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.
spironolactone Aldactone
spironolactone 50 mg daily for 6 months

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
quality of life questionnaire, 6 minute walk test
time frame: 6 mnths

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Vanderbilt University.