Defining the Role of Insulin Resistance in 'Idiopathic' Dilated Cardiomyopathy
This study has been terminated.
(concern over safety of rosiglitazone in heart failure)
Sponsor:
Stanford University
Information provided by (Responsible Party):
Michael Fowler, Stanford University
ClinicalTrials.gov Identifier:
NCT00466713
First received: April 25, 2007
Last updated: May 12, 2014
Last verified: May 2014
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Purpose
This study will investigate the effects of rosiglitazone, a medicine commonly used to treat type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure which is not due to heart attacks. The primary purpose of the study is to determine whether treatment with an insulin-sensitizing medication will improve the heart's ability to metabolize glucose (sugar).
| Condition | Intervention |
|---|---|
|
Dilated Cardiomyopathy |
Drug: Rosiglitazone therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Defining the Role of Insulin Resistance in 'Idiopathic' Dilated Cardiomyopathy |
Resource links provided by NLM:
Genetics Home Reference related topics:
DMD-associated dilated cardiomyopathy
familial dilated cardiomyopathy
MedlinePlus related topics:
Cardiomyopathy
Drug Information available for:
Rosiglitazone
U.S. FDA Resources
Further study details as provided by Stanford University:
Primary Outcome Measures:
- Myocardial glucose uptake (intrasubject before/after rosiglitazone)
- Myocardial glucose uptake (between insulin-resistant & insulin-sensitive groups)
Secondary Outcome Measures:
- Coronary flow-reserve
- 6-minute walk time
| Study Start Date: | March 2007 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Nondiabetic patients with nonischemic cardiomyopathy who are insulin-resistance or insulin-sensitive based on a fasting homeostasis model assessment (HOMA) value are eligible for the trial. At baseline, a 6-minute walk test is performed, followed by assessment of coronary flow reserve with ammonia-PET imaging before/after adenosine infusion. Subjects are then given an oral glucose load (75g), followed by PET imaging with F-18-fluoro-2-deoxyglucose (FDG). Subjects then begin taking rosiglitazone 4 mg qd x 12 weeks, after which the 6-minute walk test & PET imaging is repeated.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00466713
Please refer to this study by its ClinicalTrials.gov identifier: NCT00466713
Locations
| United States, California | |
| Stanford University Hospital | |
| Stanford, California, United States, 94305 | |
Sponsors and Collaborators
Stanford University
Investigators
| Principal Investigator: | Michael Fowler, MB | Stanford University |
More Information
| Responsible Party: | Michael Fowler, Professor of Medicine, Stanford University |
| ClinicalTrials.gov Identifier: | NCT00466713 History of Changes |
| Other Study ID Numbers: | 5367 |
| Study First Received: | April 25, 2007 |
| Last Updated: | May 12, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on September 26, 2016