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Trial · Interventional

CompletedNot applicableRegistry data

The Effect of Liraglutide on Left Ventricular Function in Chronic Heart Failure Patients With and Without Type 2 Diabetes Mellitus

NCTNCT01472640 (opens ClinicalTrials.gov in a new tab)Other idDKprotokol(LIVE)v5Other id2011-002468-26
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
240 participants (actual)
Sponsor
Flyvbjerg, Allan, DMSc · Indiv
Design
Randomized · Quadruple masking
Countries
1 country

Denmark

Start
Nov 2011
Primary completion
Sept 2015
Completion
Oct 2015
First posted
16 Nov 2011 (estimated)
Last update posted
12 Oct 2015 (estimated)
Conditions
Hyperglycemia · Chronic Heart Failure

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201120122013201420152016
  1. N/A

    The Effect of Liraglutide on Left Ventricular Function in Chronic Heart Failure Patients With and Without Type 2 Diabetes Mellitus

    NCT01472640

    Nov 2011 to Oct 2015

Registry summary

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

Type 2 diabetes (T2D) is a major risk factor of chronic heart failure (CHF). Glycemic control in patients with the combination of T2D and CHF is complicated and the currently available treatments have proven to be inadequate in clinical trials. Objectives To investigate the effect of Liraglutide compared to placebo on left ventricular ejection fraction (LVEF) in CHF patients with and without T2D. Multicenter, randomized, double blind study of 240 patients with documented systolic CHF (50% with T2DM) will be randomised. The effect of Liraglutide on left ventricular systolic and diastolic function will be evaluated by advanced echocardiography Primary outcome parameter is change in LVEF from visit 1 to week 24.

Interventions

  • liraglutideDrug
  • placeboDrug

Arms2

  • Active comparator

    Liraglutid

    Liraglutid

  • Placebo comparator

    Placebo

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Left ventricular function from visit 1 to week 24, measured by Ecco

    Time frame · 24 weeks

    Registry description

    Primary objective: To investigate the effect of Liraglutide 1.8 mg once daily compared to placebo on left ventricular function in Chronic heart faillure patients with and without type 2 diabetes after 24 weeks of treatment.

Secondary outcomes(1)

  1. left ventricular diastolic function

    Time frame · 24 weeks

    Registry description

    Secondary objectives: To investigate the effect of Liraglutide 1.8 mg once daily compared to placebo on left ventricular diastolic function, on plasma levels of NT-proBNP, on symptoms of heart failure and quality of life over 24 weeks of treatment.

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.

Completed trials do not always post results.

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

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2019

7 results

Effect of liraglutide on myocardial glucose uptake and blood flow in stable chronic heart failure patients: A double-blind, randomized, placebo-controlled LIVE sub-study.

Nielsen et al. 2019Journal of nuclear cardiology : official publication of the American Society of Nuclear Cardiologycited by 35

PMID 28770459DOI 10.1007/s12350-017-1000-2PUB-28770459

Full text at the publisher7 results
Publisher pageSee results (7)

Indexing hint: Randomized controlled trial · 2014

A protocol for a randomised, double-blind, placebo-controlled study of the effect of LIraglutide on left VEntricular function in chronic heart failure patients with and without type 2 diabetes (The LIVE Study).

Jorsal et al. 2014BMJ opencited by 22

PMID 24844271PMC4039804DOI 10.1136/bmjopen-2014-004885PUB-24844271

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

Eligibility

Who could join, as posted.

Sex
All
Age
from 30 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Able to understand the written patient information and to give informed consent * CHF, NYHA-class I, II or III at visit 0 * LVEF ≤45 % * Age 30 to 85 (both inclusive) * Stable pharmacological treatment of heart failure according to ESC guidelines for the last 3 months prior to randomisation (visit 1) For patients with diabetes exclusively: * T2D (WHO criteria), diagnosed at least 3 months prior to visit 0 * Patients with diabetes must be either untreated or treated with one or more oral anti-diabetic drugs or treated with human NPH-insulin or long-acting insulin analogue, alone or in combination with oral drugs * Stable and optimal dose of anti diabetic treatment for 30 days prior to randomisation (visit 1) Exclusion Criteria: * Myocardial infarction (MI), unstable angina or coronary revascularization within the last three months prior to visit 1 * Hospitalisation due to incompensated heart disease within 30 days prior to randomisation (visit 1) * CHF (NYHA class IV) * ECG suggestive of malign ventricular arrhythmia at visit 0 * Type 1 diabetes * HbA1c \> 10% measured at visit 0 * Use of GLP-1 receptor agonists (Exenatide, Liraglutide or other) or glitazones, pramlintide or any DPP-IV inhibitor within 30 days prior to randomisation (visit 1) * Known or suspected hypersensitivity to trial product or related products * Alcohol/drug abuse * Pregnant or nursing women * Fertile women not using chemical (tablet/pill, depot injection of progesterone, subdermal gestagen implantation, hormonal vaginal ring or transdermal hormonal patch) or mechanical (spirals) contraceptives * Cancer unless in complete remission for ≥5 years * Liver disease with elevated plasma alanine aminotransferase (ALT) of more than three times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value as being conclusive) * Inflammatory bowel disease * Acute or chronic pancreatitis * Gastroparesis * Compromised kidney function (eGFR \< 30 ml/min), dialysis or kidney transplantation * History of thyroidea adenoma or carcinoma * Severely elevated blood pressure (systolic \>180 mmHg and/or diastolic \>105 mmHg) * Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation * Simultaneous participation in any other clinical intervention trial * Receipt of an investigational drug with 30 days prior to visit 0

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