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

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Flyvbjerg, Allan, DMSc
• Collaborator: Novo Nordisk A/S
• Treatments: Liraglutide

Criteria

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