Defining the Role of Insulin Resistance in 'Idiopathic' Dilated Cardiomyopathy
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ClinicalTrials.gov Identifier: NCT00466713 |
Recruitment Status
:
Terminated
(concern over safety of rosiglitazone in heart failure)
First Posted
: April 27, 2007
Last Update Posted
: May 13, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dilated Cardiomyopathy | Drug: Rosiglitazone therapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Official Title: | Defining the Role of Insulin Resistance in 'Idiopathic' Dilated Cardiomyopathy |
Study Start Date : | March 2007 |
Actual Primary Completion Date : | December 2007 |
Actual Study Completion Date : | December 2007 |

- Myocardial glucose uptake (intrasubject before/after rosiglitazone)
- Myocardial glucose uptake (between insulin-resistant & insulin-sensitive groups)
- Coronary flow-reserve
- 6-minute walk time

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of nonischemic dilated cardiomyopathy, current NYHA class I-II congestive heart failure
- History of Stage C-D heart failure with EF ≤ 40% during the course of the disease
- Treatment with a stable comprehensive heart failure regimen for at least 3 months (including beta-blockers and ACE-inhibitors or angiotensin receptor blockers unless intolerant)
- Age > 18 yrs
Exclusion Criteria:
-
Cardiomyopathy due to one of the following:
- Ischemic heart disease
- Primary valvular lesion
- Hypertrophic cardiomyopathy
- Cardiac resynchronization within the last 3 months
- Transaminase values > 2.5 x upper limit of normal or history of liver disease
-
Diagnosis of diabetes mellitus by:
- Diabetes previously diagnosed per patient history
- 2 or more fasting glucose values > 125 mg/dl
- Current NYHA class III or IV heart failure
- Serum creatinine > 1.6 mg/dl
- History of heart transplantation
- Pregnancy or active breast feeding
- Hospitalization for decompensated heart failure within 30 days prior to enrollment.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00466713
United States, California | |
Stanford University Hospital | |
Stanford, California, United States, 94305 |
Principal Investigator: | Michael Fowler, MB | Stanford University |
Responsible Party: | Michael Fowler, Professor of Medicine, Stanford University |
ClinicalTrials.gov Identifier: | NCT00466713 History of Changes |
Other Study ID Numbers: |
5367 |
First Posted: | April 27, 2007 Key Record Dates |
Last Update Posted: | May 13, 2014 |
Last Verified: | May 2014 |
Keywords provided by Michael Fowler, Stanford University:
Nonischemic dilated cardiomyopathy |
Additional relevant MeSH terms:
Insulin Resistance Cardiomyopathies Cardiomyopathy, Dilated Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
Heart Diseases Cardiovascular Diseases Cardiomegaly Rosiglitazone Hypoglycemic Agents Physiological Effects of Drugs |