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

NCT00466713 | Terminated

• 1 other identifier: 5367
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Dilated Cardiomyopathy

Keywords

Nonischemic dilated cardiomyopathy

Outcome Measures

Primary Outcomes (2)

• Myocardial glucose uptake (intrasubject before/after rosiglitazone)

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

Secondary Outcomes (2)

• Coronary flow-reserve

• 6-minute walk time

Interventions

Rosiglitazone therapy DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Hospital

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Michael Fowler, MB

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 25, 2007
• First Posted: April 27, 2007
• Study Start: March 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: May 13, 2014

Record last verified: 2014-05

Locations

US (1)