Heart Failure
Conditions
Brief summary
The investigators planned to evaluate the effects of liraglutide on left ventricular function in chronic heart failure patients with type 2 diabetes.
Detailed description
Heart failure (HF) is a major cause of morbidity and mortality world wide. Glucagon-like peptide-1 (GLP-1) is an incretin hormone that regulates plasma glucose, and has direct effects on the cardiovascular system. In our previous study, the GLP-1 analogue liraglutide could improve left ventricular function in patients with acute myocardial infarction. However, the effects of GLP-1 on chronic heart failure patients with type 2 diabetes remain unclear. The aim of this study was to evaluate the effects of liraglutide on left ventricular function in chronic heart failure patients with type 2 diabetes.
Interventions
DRUGGLP-1
Liraglutide were taken daily for 3 months
DRUGPlacebo
Placebo were taken daily for 3 months
Sponsors
Shi Yang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Chronic heart failure patients with type 2 diabetes (NYHA-class I, II or III) were eligible for the study
Exclusion criteria
* CHF (NYHA class IV) * Type 1 diabetes * Hospitalisation due to incompensated heart disease within 30 days prior to randomisation * Myocardial infarction within the past 3 months before screening * Coronary revascularisation within the past 3 months before screening * Atrial fibrillation with ventricular frequency \>100/min in rest * ECG suggestive of malignant ventricular arrhythmia * Prolonged QT-interval (\>500 ms) * Valvular heart disease * Current myocardial or pericardial infection * Obstructive hypertrophic cardiomyopathy * Cancer unless in complete remission for ≥5 years * Acute pancreatitis * Compromised kidney function (eGFR \<30 mL/min), dialysis or kidney transplantation * History of thyroidea adenoma or carcinoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| left ventricular ejection fraction measured by 3D echocardiography | 3 months | The primary efficacy endpoint was the effect of liraglutide on left ventricular ejection fractions (LVEF) measured by 3D echocardiography at 3 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| plasma NT-proBNP levels | 3 months | a change in plasma NT-proBNP levels at 3 months after treatment |
| a change in 6-minute walk distance | 3 months | The change in 6-minute walk distance at 3 months after treatment. |
| differences in the incidences of treatment-emergent adverse events | 3 months | differences in the incidences of treatment-emergent adverse events at 3 months |
Countries
China
Outcome results
None listed