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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00466713
Other study ID # 5367
Secondary ID
Status Terminated
Phase N/A
First received April 25, 2007
Last updated May 12, 2014
Start date March 2007
Est. completion date December 2007

Study information

Verified date May 2014
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Terminated
Enrollment 0
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label


Intervention

Drug:
Rosiglitazone therapy


Locations

Country Name City State
United States Stanford University Hospital Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Myocardial glucose uptake (intrasubject before/after rosiglitazone)
Primary Myocardial glucose uptake (between insulin-resistant & insulin-sensitive groups)
Secondary Coronary flow-reserve
Secondary 6-minute walk time
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