Effects of GLP-1 on Chronic Heart Failure

NCT ID: NCT02650596

Last Updated: 2016-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

GLP-1

Intervention Type DRUG

Liraglutide were taken daily for 3 months

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo were taken daily for 3 months

Interventions

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GLP-1

Liraglutide were taken daily for 3 months

Intervention Type DRUG

Placebo

Placebo were taken daily for 3 months

Intervention Type DRUG

Other Intervention Names

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Liraglutide

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shi Yang

OTHER

Sponsor Role lead

Responsible Party

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Shi Yang

director

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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PLA General Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Yang Shi, M.D.

Role: primary

+8610-66876231

References

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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.

Reference Type BACKGROUND
PMID: 19195607 (View on PubMed)

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.

Reference Type RESULT
PMID: 26573925 (View on PubMed)

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.

Reference Type RESULT
PMID: 26542491 (View on PubMed)

Other Identifiers

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301nlxnk

Identifier Type: -

Identifier Source: org_study_id

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