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: Diagnostic, Open Label, Single Group Assignment, Efficacy Study

Study Primary Completion Date: July 2010

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.

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

Secondary Measures

• quality of life questionnaire, 6 minute walk test
  • Time Frame: 6 mnths
    Safety Issue?: No

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

Lead Sponsor: Vanderbilt University

Overall Clinical Trial Officials and Contacts

Marvin W Kronenberg, MD Principal Investigator Vanderbilt University School of Medicine  

Overall Contact: Marvin W Kronenberg, MD 615-322-8822 marvin.w.kronenberg@vanderbilt.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

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