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Effects of GLP-1 on Chronic Heart Failure

Primary Purpose

Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
GLP-1
Placebo
Sponsored by
Shi Yang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GLP-1 group

Control group

Arm Description

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: 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 7, 2016
Last Updated
January 7, 2016
Sponsor
Shi Yang
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1. Study Identification

Unique Protocol Identification Number
NCT02650596
Brief Title
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

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shi Yang

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GLP-1 group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
GLP-1
Other Intervention Name(s)
Liraglutide
Intervention Description
Liraglutide were taken daily for 3 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo were taken daily for 3 months
Primary Outcome Measure Information:
Title
left ventricular ejection fraction measured by 3D echocardiography
Description
The primary efficacy endpoint was the effect of liraglutide on left ventricular ejection fractions (LVEF) measured by 3D echocardiography at 3 months.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
plasma NT-proBNP levels
Description
a change in plasma NT-proBNP levels at 3 months after treatment
Time Frame
3 months
Title
a change in 6-minute walk distance
Description
The change in 6-minute walk distance at 3 months after treatment.
Time Frame
3 months
Title
differences in the incidences of treatment-emergent adverse events
Description
differences in the incidences of treatment-emergent adverse events at 3 months
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Shi, M.D.
Phone
+8610-66876231
Email
ggyyong@sina.com
First Name & Middle Initial & Last Name & Degree
Yu Tang Wang, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
19195607
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.
Results Reference
background
PubMed Identifier
26573925
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.
Results Reference
result
PubMed Identifier
26542491
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.
Results Reference
result

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Effects of GLP-1 on Chronic Heart Failure

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