Clinical trial NCT02650596: Effects of GLP-1 on Chronic Heart Failure
Official title: Effects of Liraglutide on Left Ventricular Function in Chronic Heart Failure Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2016-01-08
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: left ventricular ejection fraction measured by 3D echocardiography
timeFrame: 3 months
Secondary outcomes:
measure: plasma NT-proBNP levels
timeFrame: 3 months
measure: a change in 6-minute walk distance
timeFrame: 3 months
measure: differences in the incidences of treatment-emergent adverse events
timeFrame: 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: PLA General Hospital
state: Beijing
Study officials:
References:
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.
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. 2016 Jun;52(3):516-26. doi: 10.1007/s12020-015-0798-0. Epub 2015 Nov 16.
citation: 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 Heart J. 2015 Nov;170(5):845-54. doi: 10.1016/j.ahj.2015.07.014. Epub 2015 Jul 26.