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: 1
Conditions
Interventions
Trade Name: Victoza 6 mg/ml injektionsvæske
Product Name: Liraglutide
Product Code: EU/1/09/529/002
Pharmaceutical Form: Suspension for injection in pre-filled pen
Pharmaceutical form of the placebo:
Sponsors
Allan Flyvbjerg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: •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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of Liraglutide 1.8 mg once daily compared to placebo for 24 weeks on left ventricular systolic function in CHF patients with and without T2D. ;Secondary Objective: To investigate the effect of Liraglutide compared to placebo on: • Left ventricular diastolic function • Functional capacity measured by a six minute walk test (6MWT) • Plasma NT-proBNP levels • Blood pressure • Quality of life - estimated by a standardised questionnaire (Minnesota Living with Heart Failure questionnaire (MLHF)) ;Primary end point(s): Primary endpoint Change in LVEF measured by 3D echocardiography at visit 1 and at the end of treatment after 24 weeks of intervention. ;Timepoint(s) of evaluation of this end point: At the end of treatment after 24 weeks of intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints Changes from randomisation (visit 1) to end of treatment after 24 weeks of intervention in: • Diastolic function • Systolic function measured by TDI: 1) summed systolic peak velocities (s’) in the AV-plane, 2) global strain, 3) ESV, and 4) EDV • Functional capacity, measured by 6MWT • Plasma NT-proBNP levels • Blood pressure • Quality of life - evaluated by MLHF questionnaire • Hospitalisation • Mortality ;Timepoint(s) of evaluation of this end point: At the end of treatment after 24 weeks of intervention | — |
Countries
Denmark
Contacts
Public ContactLise Tarnow
Nordsjællands Hospital
Outcome results
None listed