TerminatedNot Applicable

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

Stopped: concern over safety of rosiglitazone in heart failure

United StatesStarted 2007-03

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Myocardial glucose uptake (intrasubject before/after rosiglitazone)

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

Trial details

NCT IDNCT00466713

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2007-12

View on ClinicalTrials.gov More Dilated Cardiomyopathy trials