Effects of GLP-1 on Chronic Heart Failure

Heart Failure Clinical Trial

Official title:

Effects of Liraglutide on Left Ventricular Function in Chronic Heart Failure Patients With Type 2 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02650596
• Other study ID #: 301nlxnk
• Status: Recruiting
• Phase: N/A
• First received: January 7, 2016
• Last updated: January 7, 2016
• Start date: January 2016
• Est. completion date: February 2018

Study information

• Verified date: January 2016
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China
• Study type: Interventional

Clinical Trial Summary

The investigators planned to evaluate the effects of liraglutide on left ventricular function in chronic heart failure patients with type 2 diabetes.

Description:

Heart failure (HF) is a major cause of morbidity and mortality world wide. Glucagon-like peptide-1 (GLP-1) is an incretin hormone that regulates plasma glucose, and has direct effects on the cardiovascular system. In our previous study, the GLP-1 analogue liraglutide could improve left ventricular function in patients with acute myocardial infarction. However, the effects of GLP-1 on chronic heart failure patients with type 2 diabetes remain unclear. The aim of this study was to evaluate the effects of liraglutide on left ventricular function in chronic heart failure patients with type 2 diabetes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Chronic heart failure patients with type 2 diabetes (NYHA-class I, II or III) were eligible for the study

Exclusion Criteria:

• CHF (NYHA class IV)

• Type 1 diabetes

• Hospitalisation due to incompensated heart disease within 30 days prior to randomisation

• Myocardial infarction within the past 3 months before screening

• Coronary revascularisation within the past 3 months before screening

• Atrial fibrillation with ventricular frequency >100/min in rest

• ECG suggestive of malignant ventricular arrhythmia

• Prolonged QT-interval (>500 ms)

• Valvular heart disease

• Current myocardial or pericardial infection

• Obstructive hypertrophic cardiomyopathy

• Cancer unless in complete remission for =5 years

• Acute pancreatitis

• Compromised kidney function (eGFR <30 mL/min), dialysis or kidney transplantation

• History of thyroidea adenoma or carcinoma

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• GLP-1
Liraglutide were taken daily for 3 months
• Placebo
Placebo were taken daily for 3 months

Locations

Country	Name	City	State
China	PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shi Yang

Country where clinical trial is conducted

China, 

References & Publications (3)

Chen WR, Hu SY, Chen YD, Zhang Y, Qian G, Wang J, Yang JJ, Wang ZF, Tian F, Ning QX. Effects of liraglutide on left ventricular function in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention. Am — View Citation

Chen WR, Shen XQ, Zhang Y, Chen YD, Hu SY, Qian G, Wang J, Yang JJ, Wang ZF, Tian F. Effects of liraglutide on left ventricular function in patients with non-ST-segment elevation myocardial infarction. Endocrine. 2015 Nov 16. [Epub ahead of print] — View Citation

Timmers L, Henriques JP, de Kleijn DP, Devries JH, Kemperman H, Steendijk P, Verlaan CW, Kerver M, Piek JJ, Doevendans PA, Pasterkamp G, Hoefer IE. Exenatide reduces infarct size and improves cardiac function in a porcine model of ischemia and reperfusion injury. J Am Coll Cardiol. 2009 Feb 10;53(6):501-10. doi: 10.1016/j.jacc.2008.10.033. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	left ventricular ejection fraction measured by 3D echocardiography	The primary efficacy endpoint was the effect of liraglutide on left ventricular ejection fractions (LVEF) measured by 3D echocardiography at 3 months.	3 months	No
Secondary	plasma NT-proBNP levels	a change in plasma NT-proBNP levels at 3 months after treatment	3 months	No
Secondary	a change in 6-minute walk distance	The change in 6-minute walk distance at 3 months after treatment.	3 months	No
Secondary	differences in the incidences of treatment-emergent adverse events	differences in the incidences of treatment-emergent adverse events at 3 months	3 months	Yes