Defining the Role of Insulin Resistance in ‘Idiopathic’ Dilated Cardiomyopathy

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Brief Title

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

Official Title

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

Interventional


Primary Outcome

Myocardial glucose uptake (intrasubject before/after rosiglitazone)

Secondary Outcome

 Coronary flow-reserve

Condition

Dilated Cardiomyopathy

Intervention

Rosiglitazone therapy


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug


Start Date

March 2007

Completion Date

December 2007

Primary Completion Date

December 2007

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Michael Fowler, MB, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00466713

Organization ID

5367


Responsible Party

Principal Investigator

Study Sponsor

Stanford University


Study Sponsor

Michael Fowler, MB, Principal Investigator, Stanford University


Verification Date

May 2014