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

This study is currently recruiting participants.

Verified by Stanford University, April 2007

First Received: April 25, 2007 Last Updated: April 26, 2007 History of Changes

Sponsored by:	Stanford University
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00466713

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

MedlinePlus related topics: Cardiomyopathy

Drug Information available for: Insulin Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Defining the Role of Insulin Resistance in 'Idiopathic' Dilated Cardiomyopathy

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

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

Ages Eligible for Study:	18 Years and older
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466713

Contacts

Contact: Michael Fowler, MB	6507237846	mfowler@stanford.edu
Contact: Ronald Witteles, MD	6507236661	witteles@stanford.edu

Locations

United States, California
Stanford University Hospital	Recruiting
Stanford, California, United States, 94305
Contact: Michael B Fowler, MB 650-723-7846 mfowler@stanford.edu
Contact: Ronald Witteles, MD 6507236661 witteles@stanford.edu
Principal Investigator: Michael Fowler, MB
Sub-Investigator: Ronald Witteles, MD
Sub-Investigator: David Kao, MD
Sub-Investigator: Joseph Wu, MD

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:

Michael Fowler, MB

Stanford University

More Information

No publications provided

Study ID Numbers:	5367
Study First Received:	April 25, 2007
Last Updated:	April 26, 2007
ClinicalTrials.gov Identifier:	NCT00466713 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Stanford University:

Nonischemic dilated cardiomyopathy

Study placed in the following topic categories:

Heart Diseases
Metabolic Diseases
Dilated Cardiomyopathy
Cardiomyopathy, Dilated
Cardiomyopathies
Insulin
Hyperinsulinism

Hypoglycemic Agents
Insulin Resistance
Glucose Metabolism Disorders
Cardiomegaly
Metabolic Disorder
Rosiglitazone

Additional relevant MeSH terms:

Heart Diseases
Metabolic Diseases
Cardiomyopathy, Dilated
Physiological Effects of Drugs
Cardiomyopathies
Pharmacologic Actions
Hyperinsulinism

Hypoglycemic Agents
Cardiovascular Diseases
Insulin Resistance
Glucose Metabolism Disorders
Cardiomegaly
Rosiglitazone

ClinicalTrials.gov processed this record on May 07, 2009