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

Stopped early · Phase 4

Conditions studied: Diabetes Mellitus, Type 2, Heart Failure, Diastolic

In brief

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.

Key facts

Study ID

NCT00799435

Run by

Baylor College of Medicine

People needed

2

Starts

2009-07-01

Expected to finish

2012-04-01

Last updated by the study team

2020-09-04

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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