Status:
COMPLETED
Study of the Effect of Sitagliptin on Glucose (Sugar) Metabolism in Patients With Heart Failure
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Heart Failure, Congestive
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This study will investigate the effects of sitagliptin, a medicine commonly used to treat type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure which is not due to...
Detailed Description
Screening: Patients will be screened based on existing clinic information regarding NYHA class (New York Heart Association functional class) and heart failure characteristics. Patients will be approa...
Eligibility Criteria
Inclusion
- Diagnosis of nonischemic dilated cardiomyopathy, current NYHA class I-III congestive heart failure
- Treatment with a stable comprehensive heart failure regimen for at least 3 months (including beta-blockers and ACE-inhibitors or angiotensin receptor blockers unless intolerant)
- Age \> 18 yrs
Exclusion
- Cardiomyopathy primarily due to one of the following:
- Ischemic heart disease
- Primary valvular lesion
- Hypertrophic cardiomyopathy
- Cardiac resynchronization within the last 3 months
- Calculated creatinine clearance \<30 ml/min or end-stage renal disease on dialysis. Creatinine clearance will be determined by the Cockcroft-Gault formula.
- Diagnosis of diabetes mellitus by:
- Diabetes previously diagnosed per patient history
- 2 or more fasting glucose values \> 125 mg/dl
- History of heart transplantation
- Pregnancy or active breast feeding
- Hospitalization for decompensated heart failure within 30 days prior to enrollment.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00657280
Start Date
April 1 2008
End Date
February 1 2012
Last Update
December 5 2014
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305