Primary outcome
What NCT00799435 measured first
| Measure | Usual Caren=1 | Exenatiden=1 |
|---|---|---|
| Baseline Pulse Wave Velocity | 11.4(0) | 9.3(0) |
| Follow-up Pulse Wave Velocity | NA(NA) | 10.2(0) |
Phase 4 · Exenatide
NCT00799435 trial results
Treatment With Glucagon-Like Peptide-1 Receptor, Exenatide, in Patients With Diabetes and Heart Failure With Normal Left Ventricular Ejection Fraction
- Participants
- 2
- Status
- terminated
- Completed
- 2012-04
- Sponsor
- Baylor College of Medicine
As posted on ClinicalTrials.gov (NCT00799435), updated at source Sep 4, 2020. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
The trial
How NCT00799435 was run
People with type 2 diabetes experience heart failure more often than do people without diabetes. This may be due to increased stiffness in the heart as a result of diabetes. This study will examine whether exenatide, a medication used to treat diabetes, may have beneficial effects on the heart in people with type 2 diabetes and heart failure.
- 1: Participants will receive usual care for 12 weeks. The care will be dictated by the primary physician and/or diabetologist caring for the participant. Efforts will be made to ensure that all participants receive standard measures as indicated by guidelines, with a particular emphasis on blood pressure control and glucose control.
- 2: Participants will receive exenatide for 12 weeks.
Who could join the trial
Inclusion Criteria: * Stable New York Heart Association (NYHA) Class II-IV heart failure symptoms for at least 4 weeks before study entry * Diagnosis of diastolic heart failure with a normal ejection fraction * Admitted to the hospital with a diagnosis of heart failure in the 12 months before study entry * Type 2 diabetes Exclusion Criteria: * Unstable angina, heart attack, coronary artery bypass surgery, or angioplasty in the 3 months before study entry * Angina with exertion * Technically inadequate echocardiogram * Atrial fibrillation or atrial flutter * Severe valvular heart disease * Significant kidney insufficiency (serum creatinine greater than 2.0 mg/dL or require hemodialysis) * Conditions that may be associated with changes in markers of fibrosis or collagen turnover (e.g., ongoing or active rheumatological disease, requiring significant anti-inflammatory agents, immunosuppression, pulmonary fibrosis, active cancer) * Significant history of active substance abuse * Type 1 diabetes * Type 2 diabetes requiring chronic insulin use before study entry * Active thiazolidinedione (TZD) use, because TZDs have been shown to worsen volume retention and may exacerbate signs and/or symptoms of heart failure * Pregnant or breastfeeding * Hypertrophic cardiomyopathy
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
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