Effect of Aldosterone on Energy Starvation in Heart Failure
Information source: Vanderbilt University
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Failure; Dilated Cardiomyopathy
Intervention: spironolactone (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Vanderbilt University Official(s) and/or principal investigator(s):
Marvin W Kronenberg, MD, Principal Investigator, Affiliation: Vanderbilt University School of Medicine
Overall contact:
Marvin W Kronenberg, MD, Phone: 615-322-8822, Email: marvin.w.kronenberg@vanderbilt.edu
Summary
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).
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
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
Marvin W Kronenberg, MD, Phone: 615-322-8822, Email: marvin.w.kronenberg@vanderbilt.edu
Vanderbilt Heart and Vascular Institute, Nashville, Tennessee 37232, United States; Recruiting
Marvin W. Kronenberg, MD, Phone: 615-322-8822, Email: marvin.w.kronenberg@vanderbilt.edu
Henry Ooi, MD, Phone: 615-327-4751, Email: henry.ooi@va.gov
Henry Ooi, MD, Sub-Investigator
Additional Information
Starting date: December 2007
Last updated: January 13, 2010
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