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| Tracking Information | |
|---|---|
| First Received Date ICMJE | April 18, 2008 |
| Last Updated Date | April 18, 2008 |
| Start Date ICMJE | January 2004 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE |
MMP levels [ Time Frame: 16 weeks ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | No Changes Posted |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Effects of Spironolactone on Matrix Metalloproteinases (MMPs) in Heart Failure |
| Official Title ICMJE | Effects of Spironolactone on Circulating MMPs in Patients With Chronic Heart Failure |
| Brief Summary | The purpose of this study is to evaluate the effects of spironolactone on circulating MMP levels and insulin resistance in patients with chronic heart failure. |
| Detailed Description | Myocardial fibrosis is observed in failing hearts. MMPs are considered markers of fibrosis. Recently, circulating MMPs can be measured and are elevated in patients with chronic heart failure (CHF). It has been reported that spironolactone improves myocardial fibrosis in CHF animal models. Therefore, the purpose of this study is to evaluate the effects of spironolactone on circulating MMP levels in patients with chronic heart failure. |
| Study Phase | Phase IV |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Efficacy Study |
| Condition ICMJE | Chronic Stable Heart Failure |
| Intervention ICMJE | Drug: spironolactone + furosemide |
| Study Arms / Comparison Groups | |
| 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 | Completed |
| Enrollment ICMJE | 16 |
| Completion Date | December 2005 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both |
| Ages | |
| Accepts Healthy Volunteers | |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | |
| Administrative Information | |
| NCT ID ICMJE | NCT00663195 |
| Responsible Party | Kazuhide Ogino, Center for Clinical Residency Program, Tottori University Hospital |
| Study ID Numbers ICMJE | #344 |
| Study Sponsor ICMJE | Tottori University Hospital |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | Tottori University Hospital |
| Verification Date | April 2008 |
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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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