Effects of GLP-1 on Chronic Heart Failure

Sponsor

Shi Yang (Other)

Overall Status

Unknown status

CT.gov ID

NCT02650596

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Drug: GLP-1 Drug: Placebo	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2016

Anticipated Primary Completion Date :

Feb 1, 2018

Anticipated Study Completion Date :

Feb 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GLP-1 group drug: liraglutide (Novo Nordisk, Bagsværd, Denmark); the frequency: Subcutaneous liraglutide were taken daily; duration: 3 months. After admission, the patients were treated with 0.6 mg liraglutide once daily for 1 week, then 1.2 mg liraglutide for another 1 week, and then 1.8 mg liraglutide to the end.	Drug: GLP-1 Liraglutide were taken daily for 3 months Other Names: Liraglutide
Placebo Comparator: Control group drug: placebo (Novo Nordisk, Bagsværd, Denmark); the frequency: Placebo were taken daily; duration: 3 months. After admission, the patients were treated with 0.6 mg placebo once daily for 1 week, then 1.2 mg placebo for another 1 week, and then 1.8 mg placebo to the end.	Drug: Placebo Placebo were taken daily for 3 months

Arm

Intervention/Treatment

Experimental: GLP-1 group

drug: liraglutide (Novo Nordisk, Bagsværd, Denmark); the frequency: Subcutaneous liraglutide were taken daily; duration: 3 months. After admission, the patients were treated with 0.6 mg liraglutide once daily for 1 week, then 1.2 mg liraglutide for another 1 week, and then 1.8 mg liraglutide to the end.

Drug: GLP-1

Liraglutide were taken daily for 3 months

Other Names:

Liraglutide

Placebo Comparator: Control group

drug: placebo (Novo Nordisk, Bagsværd, Denmark); the frequency: Placebo were taken daily; duration: 3 months. After admission, the patients were treated with 0.6 mg placebo once daily for 1 week, then 1.2 mg placebo for another 1 week, and then 1.8 mg placebo to the end.

Drug: Placebo

Placebo were taken daily for 3 months

Outcome Measures

Primary Outcome Measures

left ventricular ejection fraction measured by 3D echocardiography [3 months]
The primary efficacy endpoint was the effect of liraglutide on left ventricular ejection fractions (LVEF) measured by 3D echocardiography at 3 months.

Secondary Outcome Measures

plasma NT-proBNP levels [3 months]
a change in plasma NT-proBNP levels at 3 months after treatment
a change in 6-minute walk distance [3 months]
The change in 6-minute walk distance at 3 months after treatment.
differences in the incidences of treatment-emergent adverse events [3 months]
differences in the incidences of treatment-emergent adverse events at 3 months

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PLA General Hospital	Beijing	Beijing	China	100853

Sponsors and Collaborators

Shi Yang

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Shi Yang, director, Chinese PLA General Hospital

ClinicalTrials.gov Identifier:

NCT02650596

Other Study ID Numbers:

301nlxnk

First Posted:

Jan 8, 2016

Last Update Posted:

Jan 8, 2016

Last Verified:

Jan 1, 2016

Additional relevant MeSH terms:

Heart Failure

Liraglutide

Study Results

No Results Posted as of Jan 8, 2016