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NCT00064727 · ClinicalTrials.gov registry record · Phase 2
Rosiglitazone to Treat Patients With Heart Failure and Glucose Intolerance or Type II Diabetes
A Phase 2 study of Congestive Heart Failure, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 2
- Study locations
NCT00064727: Completed Phase 2 study of Congestive Heart Failure, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT00064727 is a Phase 2 study of Congestive Heart Failure that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 50 participants, below the 329-participant average among 51 other Congestive Heart Failure trials with a reported enrollment target (85% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00064727, a Phase 2 study of Congestive Heart Failure, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study will evaluate the safety and effectiveness of the drug rosiglitazone for improving heart function in patients with heart failure and glucose intolerance or type II (adult-onset) diabetes, or both. Because of a lowered sensitivity to the hormone insulin, patients with type II diabetes or glucose-intolerance do not regulate glucose (sugar) effectively. Rosiglitazone is used to treat type II diabetes, but it is not commonly given to patients with heart failure because it can cause leg swelling and, rarely, pulmonary edema. However, patients with heart failure who also have glucose intolerance or type II diabetes generally fare worse than those with heart failure alone, and therapies that decrease insulin resistance may be beneficial to these patients. Patients 21 years of age and older with heart failure and type II diabetes or glucose intolerance, or both, may be eligible for this study. Patients must be stable on current therapy for heart failure and must not have any planned surgeries for coronary artery disease. Candidates will be admitted to the NIH Clinical Center for from 2 to 7 days for screening procedures, which include a medical history and physical examination, blood and urine tests, electrocardiogram (ECG), chest x-ray, magnetic resonance imaging (MRI), exercise testing, and echocardiography (ultrasound test of the heart). Participants will be randomly assigned to receive either rosiglitazone or placebo (an identical-looking pill with no active ingredient). They will take one tablet a day for the first month, one tablet twice a day for the second month, and then two tablets twice a day from the third month to the end of the study at 6 months. During the treatment period, patients will have a history, physical examination, and blood tests every 4 weeks, exercise testing and echocardiography at 3 and 6 months, and urinalysis, electrocardiogram and MRI at 6 months. To check for fluid accumulation in the legs or lungs, patients will report their w
Conditions Studied
Interventions
- DRUG Avandia (Rosiglitazone)
- DRUG Avanclia (Rosiqlitazone)
Study Locations (2)
Maryland
- Suburban Hospital - Bethesda
- National Heart, Lung and Blood Institute (NHLBI), 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2003-07-09 |
| Est. Completion | 2007-04-11 |
| Phase | Phase 2 |
What the finished NCT00064727 record still lists
NCT00064727 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 329-participant average among 51 other Congestive Heart Failure trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Congestive Heart Failure appearing as the primary indexed condition, and to 2 interventions - of which Avandia (Rosiglitazone) is the first listed.
NCT00064727 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00064727 about?
NCT00064727 is a clinical study titled "Rosiglitazone to Treat Patients With Heart Failure and Glucose Intolerance or Type II Diabetes". This study will evaluate the safety and effectiveness of the drug rosiglitazone for improving heart function in patients with heart failure and glucose intolerance or type II (adult-onset) diabetes, or both. Because of a lowered sensitivity to the hormone insulin, patients with type II diabetes or g...
What is the current status of trial NCT00064727?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2003-07-09. Estimated completion is 2007-04-11.
What conditions does trial NCT00064727 study?
This clinical trial studies the following conditions: Congestive Heart Failure.
What interventions are being tested in trial NCT00064727?
The interventions under investigation include: Avandia (Rosiglitazone) (DRUG), Avanclia (Rosiqlitazone) (DRUG).
Who is sponsoring clinical trial NCT00064727?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00064727 being conducted?
This trial has 2 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Congestive Heart Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00064727's enrollment target sits among peer trials
50 36th of 51 higher than 16 of 51 other Congestive Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Congestive Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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