Evaluating the Use of Exenatide in People With Type 2 Diabetes and Diastolic Heart Failure

• Status: Terminated
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Exenatide; Glucagon-Like Peptide 1

Criteria

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