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

Dilated Cardiomyopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00466713
• Other study ID #: 5367
• 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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Dilated Cardiomyopathy
• Insulin Resistance

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