Overview

Study of the Effect of Sitagliptin on Glucose (Sugar) Metabolism in Patients With Heart Failure

Status:
Completed
Trial end date:
2012-02-01
Target enrollment:
0
Participant gender:
All
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 heart attacks. We hope to determine whether improving the heart's ability to use glucose in the blood may help improve the function of the heart as well. If so, this may suggest that even people who do not have frank diabetes but who do have heart failure may benefit from using this medication. This study will also investigate the effect of sitagliptin on the body's use of sugar, and of the effect of sitagliptin on blood flow to the heart.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Stanford University
Collaborator:
Merck Sharp & Dohme Corp.
Treatments:
Sitagliptin Phosphate
Criteria
Inclusion Criteria:

1. Diagnosis of nonischemic dilated cardiomyopathy, current NYHA class I-III congestive
heart failure

2. 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)

3. Age > 18 yrs

Exclusion Criteria:

1. Cardiomyopathy primarily due to one of the following:

1. Ischemic heart disease

2. Primary valvular lesion

3. Hypertrophic cardiomyopathy

2. Cardiac resynchronization within the last 3 months

3. Calculated creatinine clearance <30 ml/min or end-stage renal disease on dialysis.
Creatinine clearance will be determined by the Cockcroft-Gault formula.

4. Diagnosis of diabetes mellitus by:

1. Diabetes previously diagnosed per patient history

2. 2 or more fasting glucose values > 125 mg/dl

5. History of heart transplantation

6. Pregnancy or active breast feeding

7. Hospitalization for decompensated heart failure within 30 days prior to enrollment.