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Trial · Interventional

Status unknownNot applicableRegistry data

Clinical Study of Liraglutide in Improving Cardiac Function for Patients With Ischemic Cardiomyopathy

NCTNCT02930265 (opens ClinicalTrials.gov in a new tab)Other idqs20160920
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Not applicable
Enrollment
400 participants (estimated)
Sponsor
Chinese PLA General Hospital · Other
Design
Randomized · Quadruple masking
Countries
1 country

China

Start
Sept 2016
Primary completion
Feb 2018 (estimated)
Completion
Mar 2018 (estimated)
First posted
12 Oct 2016 (estimated)
Last update posted
12 Oct 2016 (estimated)
Conditions
Ischemic Cardiomyopathy

Timeline

1 trial

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

    Clinical Study of Liraglutide in Improving Cardiac Function for Patients With Ischemic Cardiomyopathy

    NCT02930265

    Sept 2016 to est. Mar 2018

Registry summary

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

It has been known that liraglutide reduces infarct size, improved left ventricular function, reduce myocardial stunning, and play a protective role in myocardial ischemia-reperfusion injury for patients with acute myocardial infarction. But it is not sure whether liraglutide can benefit patients with ischemic cardiomyopathy. This study aim to explore the effect of Liraglutide in improving cardiac function for patients with ischemic cardiomyopathy.

Interventions

  • LiraglutideDrug

Arms2

  • Active comparator

    Liraglutide intervention group

    Liraglutide intervention group will accept ischemic cardiomyopathy conventional drugs and Liraglutide (Novo Nordisk, specifications: 18mg / 3ml; 1.8mg subcutaneous injection of 1 / day)

  • No intervention

    Control group

    Control group will accept ischemic cardiomyopathy conventional drugs and a placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. main adverse cardiovascular events

    Time frame · Followed up for 6 months after enrolled in the study

    Registry description

    Primary end point of the study is main adverse cardiovascular events including Recurrent myocardial infarction, recurrent angina, revascularization, all-cause death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for heart failure again

Secondary outcomes(4)

  1. New York Heart Association functional class

    Time frame · Followed up for 6 months after enrolled in the study

  2. left ventricular ejection fraction

    Time frame · Followed up for 6 months after enrolled in the study

  3. 6-minute walk test

    Time frame · Followed up for 6 months after enrolled in the study

  4. KCCQ (Kansas City cardiomyopathy questionnaire) clinical total score

    Time frame · Followed up for 6 months after enrolled in the study

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

Studies13

Studies that cite this trial.

Studies with results

10 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 · 2016

3 results

Effects of liraglutide on no-reflow in patients with acute ST-segment elevation myocardial infarction.

Chen et al. 2016International journal of cardiologycited by 35

PMID 26849684DOI 10.1016/j.ijcard.2015.12.009PUB-26849684

Full text at the publisher3 results
Publisher pageSee results (3)

Indexing hint: Randomized controlled trial · 2016

8 results

Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes.

Marso et al. 2016The New England journal of medicinecited by 5,535

PMID 27295427PMC4985288DOI 10.1056/nejmoa1603827PUB-27295427

Rights unknown8 results
Source linkSee results (8)

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: Randomized controlled trial · 2013

8 results

Benefits of liraglutide treatment in overweight and obese older individuals with prediabetes.

Kim et al. 2013Diabetes carecited by 82

PMID 23835684PMC3781545DOI 10.2337/dc13-0354PUB-23835684

Free to read · publisher termsCC BY-NC-ND8 results
Read at sourceSee results (8)

Indexing hint: Randomized controlled trial · 2012

8 results

Exenatide reduces reperfusion injury in patients with ST-segment elevation myocardial infarction.

Lønborg et al. 2012European heart journalcited by 421

PMID 21920963DOI 10.1093/eurheartj/ehr309PUB-21920963

Rights unknown8 results
Source linkSee results (8)

Indexing hint: Randomized controlled trial · 2012

6 results

Exenatide alters myocardial glucose transport and uptake depending on insulin resistance and increases myocardial blood flow in patients with type 2 diabetes.

Gejl et al. 2012The Journal of clinical endocrinology and metabolismcited by 64

PMID 22544917DOI 10.1210/jc.2011-3456PUB-22544917

Rights unknown6 results
Source linkSee results (6)

Indexing hint: Randomized controlled trial · 2009

4 results

Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, parallel-treatment trial.

Garber et al. 2009Lancet (London, England)cited by 798

PMID 18819705DOI 10.1016/s0140-6736(08)61246-5PUB-18819705

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

Indexing hint: Randomized controlled trial · 2009

8 results

Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study.

Nauck et al. 2009Diabetes carecited by 849

PMID 18931095PMC2606836DOI 10.2337/dc08-1355PUB-18931095

Free to read · publisher termsCC BY-NC-ND8 results
Read at sourceSee results (8)

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)

More studies

3 studies on this page

PubMed tag: none · 2016

Liraglutide protects cardiac microvascular endothelial cells against hypoxia/reoxygenation injury through the suppression of the SR-Ca(2+)-XO-ROS axis via activation of the GLP-1R/PI3K/Akt/survivin pathways.

Zhang et al. 2016Free radical biology & medicinecited by 160

PMID 27038735DOI 10.1016/j.freeradbiomed.2016.03.035PUB-27038735

Full text at the publisher
Publisher page

PubMed tag: none · 2009

GLP-1R agonist liraglutide activates cytoprotective pathways and improves outcomes after experimental myocardial infarction in mice.

Noyan-Ashraf et al. 2009Diabetescited by 463

PMID 19151200PMC2661586DOI 10.2337/db08-1193PUB-19151200

Free to read · publisher termsCC BY-NC-ND
Read at source

Indexing hint: Randomized controlled trial · 2009

Corrected

Efficacy and safety of the human glucagon-like peptide-1 analog liraglutide in combination with metformin and thiazolidinedione in patients with type 2 diabetes (LEAD-4 Met+TZD).

Zinman et al. 2009Diabetes carecited by 621

PMID 19289857PMC2699702DOI 10.2337/dc08-2124PUB-19289857

Free to read · publisher termsCC BY-NC-ND
Read at sourceRead the notice

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Patients With Ischemic Cardiomyopathy: The clinical manifestations of heart failure (NYHA class II-IV grade), evidence of cardiac dysfunction (LVEF ≤40%, and LVEDD ≥55mm) and previous coronary angiography showed one or more severe coronary artery stenosis. Exclusion Criteria: * Valvular heart disease * dilated cardiomyopathy * patients requiring emergency PCI * patients with cardiogenic shock; * there have been recent acute myocardial infarction in one month; * there have been recent acute stroke in one month; * estimated glomerular filtration over rate eGFR \<30ml / min / 1.73m2 (according to MDRD formula); * malignant tumor * severe liver failure * respiratory failure

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