Clinical trial NCT02344641: Efficacy and Mechanism of Exenatide on Improving Heart Function in Type 2 Diabetes With Heart Failure Patients
Official title: Efficacy and Mechanism of Exenatide on Improving Heart Function in Type 2 Diabetes With Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Heart Failure
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The study enrolls 234 patients with type 2 diabetes and heart failure. The patients have an New York Heart Association (NYHA) functional class of II to IV, are randomly assigned to 2 groups. One group use exenatide , the other group is control group and each group has 117 patients. At the baseline, the 3rd day, the 28th day patients are required to complete the heart failure examination: plasma N-terminal pro-B-type natriuretic peptide(NT-proBNP), 6-min walking distance, echocardiographic measures, patient quality of life(MLHFQ). At the end of 4-week follow-up, we evaluate the efficacy of heart function improvements after treatment with exenatide and also investigate the mechanisms of exenatide improving heart function .

Eligibility criteria: 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.

Primary outcomes:
measure: The change in plasma NT-proBNP level after using exenatide for 4 weeks
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fuwai Hospital, National Center for Cardiovascular Disease
name: YanYan Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: