iraglutide in chronic heart failure. A randomised, double-blind, placebo-controlled study of the effect of LIraglutide on the left VEntricular function in patients with chronic heart failure with and without type 2 diabetes (The LIVE-study).
- Conditions
- Primary objective: To investigate the effect of Liraglutide 1.8 mg once daily compared to placebo on left ventricular eject fraction in Chromic heart failure patients with and without Type 2 diabetes after 24 weeks of treatment. 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.MedDRA version: 16.1Level: LLTClassification code 10019279Term: Heart failureSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2011-002468-26-DK
- Lead Sponsor
- Allan Flyvbjerg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
•CHF (NYHA-class I, II or III) at visit 0
•LVEF = 45 % (measured within 30 days prior to visit 1)
•Age 30 to 85 (both inclusive)
•Optimal medical treatment in 3 months and stable treatment with ACE-inhibitors, AT2-antagonists, beta-blockers and/or aldosterone antagonists for the last 30 days prior to randomisation (visit 1)
•Able to understand the written patient information and to give informed consent
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 dose of anti diabetic treatment for 30 days prior to randomisation (visit 1)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80
•Cardiac
•Myocardial infarction (MI) within the last three months prior to visit 0
•Coronary revascularization within the last three months prior to visit 0
•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
•Prolonged QT-interval (>500 ms) at visit 0
•Uncorrected valvular heart disease at visit 0
•Current myocardial or pericardial infection
•Obstructive hypertrophic cardiomyopathy
•Current planned coronary revascularisation
•Poor image quality on echocardiography
Diabetes
•Type 1 diabetes
•HbA1c >10% measured at visit 0
•Diabetic gastroparesis
•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)
•Use of insulin other than human NPH-insulin or long-acting insulin analogue within 30 days prior to randomisation (visit 1)
Other/general
•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
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method