NCT02650596

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2016

Enrollment Period

2.1 years

First QC Date

January 7, 2016

Last Update Submit

January 7, 2016

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • plasma NT-proBNP levels

    3 months

  • a change in 6-minute walk distance

    3 months

  • differences in the incidences of treatment-emergent adverse events

    3 months

Study Arms (2)

GLP-1 group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Interventions

GLP-1DRUG

Liraglutide were taken daily for 3 months

Also known as: Liraglutide
GLP-1 group
PlaceboDRUG

Placebo were taken daily for 3 months

Control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 19195607BACKGROUND

  • 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.

    PMID: 26573925RESULT

  • 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.

    PMID: 26542491RESULT

MeSH Terms

Conditions

Heart Failure

Interventions

Glucagon-Like Peptide 1Liraglutide

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
director

Study Record Dates

First Submitted

January 7, 2016

First Posted

January 8, 2016

Study Start

January 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

January 8, 2016

Record last verified: 2016-01

Locations

CN(1)