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Defining the Role of Insulin Resistance in 'Idiopathic' Dilated Cardiomyopathy

This study has been terminated.

(concern over safety of rosiglitazone in heart failure)

Sponsor:

ClinicalTrials.gov Identifier:

NCT00466713

First Posted: April 27, 2007

Last Update Posted: May 13, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Michael Fowler, Stanford University

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 Intervention Model: Single Group Assignment Masking: None (Open Label)
Official Title:	Defining the Role of Insulin Resistance in 'Idiopathic' Dilated Cardiomyopathy

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked dilated cardiomyopathy familial dilated cardiomyopathy

MedlinePlus related topics: Cardiomyopathy

Drug Information available for: Rosiglitazone Rosiglitazone Maleate

Genetic and Rare Diseases Information Center resources: Dilated Cardiomyopathy

U.S. FDA Resources

Further study details as provided by Michael Fowler, 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)

Detailed Description:

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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

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

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
First Submitted:	April 25, 2007
First Posted:	April 27, 2007
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

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