Dilated CardiomyopathyNCT00466713
Defining the Role of Insulin Resistance in 'Idiopathic' Dilated Cardiomyopathy
A study testing Rosiglitazone therapy in people with Dilated Cardiomyopathy, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dilated Cardiomyopathy
- What is being tested?
- Rosiglitazone therapy
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Hospital
Stanford, California, 94305
About this study
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).
Read the 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.
- Conditions
- Dilated Cardiomyopathy
- Being tested
- Rosiglitazone therapy
- Keywords
- Nonischemic dilated cardiomyopathy
- Medical subject headings
- Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosiglitazone therapyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionDec 2007
- Study completionDec 2007
Why it stopped: concern over safety of rosiglitazone in heart failure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dilated CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Fowler, Stanford University
- Investigators
- Michael Fowler, MB, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00466713
- Sponsor's protocol ID
- 5367
- Status last verified
- May 2014
- First submitted
- 25 Apr 2007
- Last updated
- 13 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Role of Insulin Resistance in 'Idiopathic' Dilated Cardiomyopathy
- ClinicalTrials.gov ID
- NCT00466713
- Acronym / sponsor ID
- 5367
- Conditions
- Dilated Cardiomyopathy
- Keywords
- Nonischemic dilated cardiomyopathy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: concern over safety of rosiglitazone in heart failure
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 27 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- Cardiomyopathy due to one of the following:
- 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:
- Current NYHA class III or IV heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosiglitazone therapy | Drug | – |
Primary outcome
Myocardial glucose uptake (intrasubject before/after rosiglitazone)
Myocardial glucose uptake (between insulin-resistant & insulin-sensitive groups)
2 secondary outcomes
Coronary flow-reserve
6-minute walk time
Results and safety
The study was stopped early (reason given: concern over safety of rosiglitazone in heart failure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Fowler, MB principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rosiglitazone therapy in people with Dilated Cardiomyopathy, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: concern over safety of rosiglitazone in heart failure). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial glucose uptake (intrasubject before/after rosiglitazone). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2014.