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Effect of Aldosterone on Energy Starvation in Heart Failure

Information source: Vanderbilt University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Heart Failure; Nonischemic Dilated Cardiomyopathy

Intervention: spironolactone (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Vanderbilt University

Official(s) and/or principal investigator(s):
Marvin W Kronenberg, MD, Principal Investigator, Affiliation: Vanderbilt University School of Medicine

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).

Clinical Details

Official title: Effect of Aldosterone on Energy Starvation in Heart Failure

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome: left ventricular work-metabolic index, myocardial blood flow by magnetic resonance imaging, subendocardial hypoxia by magnetic resonance imaging, myocardial fibrosis by magnetic resonance imaging

Secondary outcome: quality of life questionnaire, 6 minute walk test

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Vanderbilt Heart and Vascular Institute, Nashville, Tennessee 37232, United States
Additional Information

Starting date: December 2007
Last updated: June 1, 2015

Page last updated: August 23, 2015

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