- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00466713
Defining the Role of Insulin Resistance in 'Idiopathic' Dilated Cardiomyopathy
May 12, 2014 updated by: Michael Fowler, Stanford University
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).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Myocardial glucose uptake (intrasubject before/after rosiglitazone)
|
Myocardial glucose uptake (between insulin-resistant & insulin-sensitive groups)
|
Secondary Outcome Measures
Outcome Measure |
---|
Coronary flow-reserve
|
6-minute walk time
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael Fowler, MB, Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
April 25, 2007
First Submitted That Met QC Criteria
April 26, 2007
First Posted (Estimate)
April 27, 2007
Study Record Updates
Last Update Posted (Estimate)
May 13, 2014
Last Update Submitted That Met QC Criteria
May 12, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5367
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dilated Cardiomyopathy
-
Bristol-Myers SquibbTerminatedPrimary Familial Dilated CardiomyopathyUnited States, Germany, Spain, United Kingdom
-
Hospital General Universitario Gregorio MarañonMinisterio de Sanidad, Servicios Sociales e IgualdadUnknownPrimary Idiopathic Dilated CardiomyopathySpain
-
Nantes University HospitalCompleted
-
IRCCS SYNLAB SDNCompletedPatients With Ischemic or Idiopathic Dilated CardiomyopathyItaly
-
Capricor Inc.National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health... and other collaboratorsUnknownHeart Failure | Ischemic Cardiomyopathy | Nonischemic Cardiomyopathy | Dilated Cardiomyopathy (DCM)United States
-
Ray HershbergerNational Heart, Lung, and Blood Institute (NHLBI); National Human Genome Research...Active, not recruiting
-
University of TehranCompletedDilated CardiomyopathyIran, Islamic Republic of
-
McGill University Health Centre/Research Institute...Unknown
-
Chung Shan Medical UniversityCompletedPediatric Dilated CardiomyopathyTaiwan
-
Qingdao UniversityUnknownDilated CardiomyopathyChina
Clinical Trials on Rosiglitazone therapy
-
China Medical University HospitalCompletedType 2 Diabetes Mellitus With Features of Insulin ResistanceTaiwan
-
Solvay PharmaceuticalsCompletedType 2 Diabetes MellitusUnited Kingdom
-
Centre Hospitalier Universitaire DijonCompleted
-
GlaxoSmithKlineCompletedDiabetes Mellitus, Type 2
-
GlaxoSmithKlineCompletedDiabetes Mellitus, Type 2
-
GlaxoSmithKlineCompletedNeuropathy, DiabeticNetherlands
-
Medstar Health Research InstituteGlaxoSmithKlineTerminated
-
Baskent UniversityCompletedObesity | Type 2 Diabetes MellitusTurkey
-
Hospital Authority, Hong KongUnknownCardiovascular Diseases | Kidney Diseases | Chronic DiseaseChina
-
GlaxoSmithKlineCompletedAlzheimer's DiseaseUnited States, Australia, Spain, Bulgaria, Poland, Germany, Philippines, Singapore, Belgium, Canada, Hong Kong, Korea, Republic of, Finland, Slovenia, Czechia, France, South Africa, Sweden, Netherlands, Malaysia, United Kingdom, S...