Heart Failure Clinical Trial
Official title:
Efficacy and Mechanism of Exenatide on Improving Heart Function in Type 2 Diabetes With Heart Failure Patients
The study evaluates the efficacy of heart function improvements in type 2 diabetes and heart failure patients with exenatide, and also investigates the mechanisms of exenatide improving heart function.
Status | Not yet recruiting |
Enrollment | 234 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Diagnosed Type 2 diabetes mellitus 2. HbA1c 7%-10% and Fasting plasma glucose(FBG) <10mmol/L 3. Age 18-65 years 4. NT-proBNP level= 450 pg/ml 5. Left ventricular ejection fraction (LVEF)<40% Exclusion Criteria: 1. Uncorrected primary vascular disease 2. congenital heart disease 3. Left ventricular outflow obstruction 4. Myocarditis 5. Aneurysm 6. uncontrolled severe arrhythmia 7. cardiogenic shock 8. unstable angina, or acute myocardial infarction 9. Severe primary hepatic, renal, or hematologic disease 10. Cr>194.5 mmol/l or K+>5.5 mmol/l 11. Systolic blood pressure (SBP) =180mm Hg or diastolic blood pressure (DBP) =110mm Hg 12. Alanine aminotransferase (ALT) >3 times the upper normal limit 13. Patients were likely to undergo coronary artery bypass graft surgery during the following 4 weeks 14. Patients had undergone or were likely to undergo cardiac resynchronization therapy 15. Pregnant or lactating known 16. Suspected to be allergic to the study drugs 17. Use dipeptidyl peptidase-4 (DPP-4) or glucagon-like peptide-1 (GLP-1) drug in 3 months 18. Hyperthyroidism and Hypothyroidism 19. Tumor 20. Received another investigational drug within 30 days prior to randomization 21. Severe mental health condition or other uncontrolled systemic disease. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Chinese Academy of Medical Sciences, Fuwai Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The change in plasma NT-proBNP level after using exenatide for 4 weeks | 4 weeks | No |
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