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Trial · Interventional

Status unknownNot applicableRegistry data

Effects of GLP-1 on Chronic Heart Failure

NCTNCT02650596 (opens ClinicalTrials.gov in a new tab)Other id301nlxnk
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Overview

Status
Status unknown
Phase
Not applicable
Enrollment
68 participants (estimated)
Sponsor
Shi Yang · Other
Design
Randomized · Double masking
Countries
1 country

China

Start
Jan 2016
Primary completion
Feb 2018 (estimated)
Completion
Feb 2018 (estimated)
First posted
8 Jan 2016 (estimated)
Last update posted
8 Jan 2016 (estimated)
Conditions
Heart Failure

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2016201720182019
  1. N/A

    Effects of GLP-1 on Chronic Heart Failure

    NCT02650596

    Jan 2016 to est. Feb 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • GLP-1Drug
  • PlaceboDrug

Arms2

  • 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.

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. left ventricular ejection fraction measured by 3D echocardiography

    Time frame · 3 months

    Registry description

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

Secondary outcomes(3)

  1. plasma NT-proBNP levels

    Time frame · 3 months

    Registry description

    a change in plasma NT-proBNP levels at 3 months after treatment

  2. a change in 6-minute walk distance

    Time frame · 3 months

    Registry description

    The change in 6-minute walk distance at 3 months after treatment.

  3. differences in the incidences of treatment-emergent adverse events

    Time frame · 3 months

    Registry description

    differences in the incidences of treatment-emergent adverse events at 3 months

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

3 studies on this page

Indexing hint: Randomized controlled trial · 2016

4 results

Effects of liraglutide on left ventricular function in patients with non-ST-segment elevation myocardial infarction.

Chen et al. 2016Endocrinecited by 69

PMID 26573925DOI 10.1007/s12020-015-0798-0PUB-26573925

Full text at the publisher4 results
Publisher pageSee results (4)

Indexing hint: Randomized controlled trial · 2015

5 results

Effects of liraglutide on left ventricular function in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.

Chen et al. 2015American heart journalcited by 102

PMID 26542491DOI 10.1016/j.ahj.2015.07.014PUB-26542491

Full text at the publisher5 results
Publisher pageSee results (5)

Indexing hint: Animal study · 2009

12 results

Exenatide reduces infarct size and improves cardiac function in a porcine model of ischemia and reperfusion injury.

Timmers et al. 2009Journal of the American College of Cardiologycited by 361

PMID 19195607DOI 10.1016/j.jacc.2008.10.033PUB-19195607

Full text at the publisher12 results
Publisher pageSee results (12)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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