Status:
TERMINATED
Evaluating the Use of Exenatide in People With Type 2 Diabetes and Diastolic Heart Failure
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Diabetes Mellitus, Type 2
Heart Failure, Diastolic
Eligibility:
All Genders
30+ years
Phase:
PHASE4
Brief 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 wh...
Detailed Description
Diastolic heart failure is a life-threatening condition that occurs when the ventricles of the heart become stiff and do not fully relax, preventing the heart from properly filling with blood. The cir...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00799435
Start Date
July 1 2009
End Date
April 1 2012
Last Update
September 4 2020
Active Locations (1)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030