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| Sponsor: | Vanderbilt University |
|---|---|
| Information provided by: | Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00574119 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Failure Dilated Cardiomyopathy |
Drug: spironolactone |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Effect of Aldosterone on Energy Starvation in Heart Failure |
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: 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.
|
Drug: spironolactone
spironolactone 50 mg daily for 6 months
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Marvin W Kronenberg, MD | 615-322-8822 | marvin.w.kronenberg@vanderbilt.edu |
| Contact: Henry Ooi, MD | 615-327-4751 | henry.ooi@va.gov |
| United States, Tennessee | |
| Vanderbilt Heart and Vascular Institute | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Marvin W. Kronenberg, MD 615-322-8822 marvin.w.kronenberg@vanderbilt.edu | |
| Contact: Henry Ooi, MD 615-327-4751 henry.ooi@va.gov | |
| Sub-Investigator: Henry Ooi, MD | |
| Principal Investigator: | Marvin W Kronenberg, MD | Vanderbilt University School of Medicine |
More Information
| Responsible Party: | Vanderbilt University School of Medicine ( Marvin W. Kronenberg, M.D. ) |
| Study ID Numbers: | IRB 070824 |
| Study First Received: | December 13, 2007 |
| Last Updated: | January 13, 2010 |
| ClinicalTrials.gov Identifier: | NCT00574119 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
heart failure positron emission tomography magnetic resonance imaging myocardial energetics myocardial perfusion |
|
Starvation Heart Failure Heart Diseases Hormone Antagonists Cardiomyopathy, Dilated Diuretics Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Cardiovascular Agents Cardiomyopathies |
Pharmacologic Actions Spironolactone Malnutrition Aldosterone Antagonists Natriuretic Agents Therapeutic Uses Nutrition Disorders Cardiovascular Diseases Cardiomegaly |
