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

This study has been terminated.
(concern over safety of rosiglitazone in heart failure)
Sponsor:
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
  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:


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)
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
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

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

No publications provided

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:
Cardiomyopathy, Dilated
Insulin Resistance
Cardiomyopathies
Cardiomegaly
Heart Diseases
Cardiovascular Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014