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| Tracking Information | |||||||||
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| First Received Date ICMJE | December 13, 2007 | ||||||||
| Last Updated Date | April 13, 2009 | ||||||||
| Start Date ICMJE | December 2007 | ||||||||
| Estimated Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00574119 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
quality of life questionnaire, 6 minute walk test [ Time Frame: 6 mnths ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effect of Aldosterone on Energy Starvation in Heart Failure | ||||||||
| Official Title ICMJE | Effect of Aldosterone on Energy Starvation in Heart Failure | ||||||||
| Brief 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). |
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| Detailed Description | |||||||||
| Study Phase | Phase IV | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Diagnostic, Open Label, Single Group Assignment, Efficacy Study | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: spironolactone | ||||||||
| Study Arms / Comparison Groups | 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. | ||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||
| Estimated Completion Date | July 2010 | ||||||||
| Estimated Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00574119 | ||||||||
| Responsible Party | Marvin W. Kronenberg, M.D., Vanderbilt University School of Medicine | ||||||||
| Study ID Numbers ICMJE | IRB 070824 | ||||||||
| Study Sponsor ICMJE | Vanderbilt University | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Vanderbilt University | ||||||||
| Verification Date | April 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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