Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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

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. Identifier: NCT00466713
Recruitment Status : Terminated (concern over safety of rosiglitazone in heart failure)
First Posted : April 27, 2007
Last Update Posted : May 13, 2014
Information provided by (Responsible Party):
Michael Fowler, Stanford University

Tracking Information
First Submitted Date  ICMJE April 25, 2007
First Posted Date  ICMJE April 27, 2007
Last Update Posted Date May 13, 2014
Study Start Date  ICMJE March 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2007)
  • Myocardial glucose uptake (intrasubject before/after rosiglitazone)
  • Myocardial glucose uptake (between insulin-resistant & insulin-sensitive groups)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2007)
  • Coronary flow-reserve
  • 6-minute walk time
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Defining the Role of Insulin Resistance in 'Idiopathic' Dilated Cardiomyopathy
Official Title  ICMJE Defining the Role of Insulin Resistance in 'Idiopathic' Dilated Cardiomyopathy
Brief Summary 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).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Dilated Cardiomyopathy
Intervention  ICMJE Drug: Rosiglitazone therapy
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00466713
Other Study ID Numbers  ICMJE 5367
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Fowler, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Fowler, MB Stanford University
PRS Account Stanford University
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP