Rosiglitazone to Treat Patients With Heart Failure and Glucose Intolerance or Type II Diabetes
Status:
Completed
Trial end date:
2007-04-11
Target enrollment:
Participant gender:
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
weight and symptoms every 2 weeks throughout the study. After the 6-month treatment period,
patients will be put back on the diabetes medicines they were taking before the study. Their
physicians will be notified of possible modifications in treatment for maintaining optimum
glucose tolerance.
Six months after completing treatment (one year after beginning the study), patients will
return to the Clinical Center for blood tests to measure the long-term effects of
rosiglitazone and to evaluate progress. They will then be invited to return to the clinic for
annual checkups, if possible, or for yearly follow-up by mail or telephone to review their
health status.