Efficacy and Mechanism of Exenatide on Improving Heart Function in Type 2 Diabetes With Heart Failure Patients

Heart Failure Clinical Trial

Official title:

Efficacy and Mechanism of Exenatide on Improving Heart Function in Type 2 Diabetes With Heart Failure Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02344641
• Other study ID #: ISSEXEN0054
• Status: Not yet recruiting
• Phase: N/A
• First received: January 13, 2015
• Last updated: January 26, 2015
• Start date: January 2015
• Est. completion date: December 2016

Study information

• Verified date: January 2015
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: XinXing Feng, MD
• Phone: :86-10-88396587
• Email: xinxing_feng[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Heart Failure
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Exenatide

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in plasma NT-proBNP level after using exenatide for 4 weeks		4 weeks	No