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TerminatedNCT00466713Updated May 13, 2014

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

An interventional study of Rosiglitazone therapy in Dilated Cardiomyopathy, sponsored by Stanford University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-13.

Sponsored by Stanford University · Not applicable and Interventional

Why this study was terminated
concern over safety of rosiglitazone in heart failure
Phase
Not applicable
Study type
Interventional
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study 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).

Read the 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.

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Conditions studied

  • Dilated Cardiomyopathy

Keywords

  • Nonischemic dilated cardiomyopathy
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In context

Cardiomyopathies

1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.

Browse Cardiomyopathies studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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.
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Study design

Phase
Not applicable
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)

Interventions

  • DrugRosiglitazone therapy
06

What researchers measure

Primary outcomes

  1. Myocardial glucose uptake (intrasubject before/after rosiglitazone)

  2. Myocardial glucose uptake (between insulin-resistant & insulin-sensitive groups)

Secondary outcomes

  1. Coronary flow-reserve

  2. 6-minute walk time

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Study locations

1 site
  • Stanford University Hospital
    Stanford, California 94305, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00466713
Lead sponsor
Stanford University
Responsible party
Michael Fowler (Professor of Medicine, Stanford University) — Principal investigator
First posted
Apr 27, 2007
Start date
Mar 2007
Primary completion
Dec 2007
Completion
Dec 2007
Last update
May 13, 2014

Study contacts

Michael Fowler, MB
principal investigator · Stanford University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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