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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Stanford University.
Recruitment status was  Recruiting
Information provided by:
Stanford University Identifier:
First received: April 25, 2007
Last updated: April 26, 2007
Last verified: April 2007

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:

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its identifier: NCT00466713

Contact: Michael Fowler, MB 6507237846
Contact: Ronald Witteles, MD 6507236661

United States, California
Stanford University Hospital Recruiting
Stanford, California, United States, 94305
Contact: Michael B Fowler, MB    650-723-7846   
Contact: Ronald Witteles, MD    6507236661   
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
Principal Investigator: Michael Fowler, MB Stanford University
  More Information

No publications provided Identifier: NCT00466713     History of Changes
Other Study ID Numbers: 5367
Study First Received: April 25, 2007
Last Updated: April 26, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Nonischemic dilated cardiomyopathy

Additional relevant MeSH terms:
Cardiomyopathy, Dilated
Insulin Resistance
Heart Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions processed this record on April 17, 2014