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

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

Study Description
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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).

Condition or disease Intervention/treatment Phase
Dilated Cardiomyopathy Drug: Rosiglitazone therapy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Defining the Role of Insulin Resistance in 'Idiopathic' Dilated Cardiomyopathy
Study Start Date : March 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Myocardial glucose uptake (intrasubject before/after rosiglitazone)
  2. Myocardial glucose uptake (between insulin-resistant & insulin-sensitive groups)

Secondary Outcome Measures :
  1. Coronary flow-reserve
  2. 6-minute walk time

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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United States, California
Stanford University Hospital
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Michael Fowler, MB Stanford University
More Information
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Responsible Party: Michael Fowler, Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT00466713     History of Changes
Other Study ID Numbers: 5367
First Posted: April 27, 2007    Key Record Dates
Last Update Posted: May 13, 2014
Last Verified: May 2014

Keywords provided by Michael Fowler, Stanford University:
Nonischemic dilated cardiomyopathy

Additional relevant MeSH terms:
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Insulin Resistance
Cardiomyopathies
Cardiomyopathy, Dilated
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
 Heart Diseases
Cardiovascular Diseases
Cardiomegaly
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs