Jorsal Anders, Wiggers Henrik, Holmager Pernille, Nilsson Brian, Nielsen Roni, Boesgaard Trine Welløv, Kumme Anja, Møller Jacob Eifer, Videbæk Lars, Kistorp Caroline, Gustafsson Ida, Tarnow Lise, Flyvbjerg Allan
Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark Department of Clinical Medicine, Faculty of Health, Aarhus University, Aarhus, Denmark.
Department of Endocrinology and Internal Medicine, Herlev University Hospital, Copenhagen, Denmark.
BMJ Open. 2014 May 20;4(5):e004885. doi: 10.1136/bmjopen-2014-004885.
Heart failure is one of the most common cardiovascular complications of diabetes and the most disabling and deadly complication too. Many antidiabetic agents have been associated with increased morbidity and mortality in a subset of patients with chronic heart failure (CHF); thus, new treatment modalities are warranted. Interestingly, a beneficial effect of the incretin hormone, GLP-1, on cardiac function has been suggested in patients with diabetes and patients without diabetes. Liraglutide (Victoza) is a GLP-1 analogue developed for the treatment of type 2 diabetes (T2D); however, its impact on cardiac function has not previously been investigated in patients with CHF. This prompted us to investigate whether liraglutide treatment for 24 weeks improves left ventricular ejection fraction (LVEF) in patients with CHF with and without T2D compared with placebo treatment.
An investigator-initiated, multicentre, randomised, double-blind, parallel, placebo-controlled intervention trial. In total, 240 patients with CHF (with and without T2D) with LVEF≤45% will be randomised to either subcutaneous injection of liraglutide 1.8 mg or matching placebo once daily for 24 weeks. The effect of liraglutide on left ventricular function will be evaluated by advanced echocardiography, including three-dimensional contrast echocardiography.
The study will be performed and monitored according to the Good Clinical Practice-International Conference on Harmonisation (GCP-ICH) regulations and conducted according to the principles of the Helsinki Declaration. The Danish Medicines Agency, the local Research Ethics Committee and the Danish Data Protection Agency have approved the study.
ClinicalTrials.gov Identifier: NCT01472640.
心力衰竭是糖尿病最常见的心血管并发症之一，也是最具致残性和致命性的并发症。许多抗糖尿病药物与一部分慢性心力衰竭（CHF）患者的发病率和死亡率增加有关；因此，需要新的治疗方式。有趣的是，肠促胰岛素激素胰高血糖素样肽-1（GLP-1）对糖尿病患者和非糖尿病患者的心脏功能都有有益作用。利拉鲁肽（维达列汀）是一种开发用于治疗2型糖尿病（T2D）的GLP-1类似物；然而，此前尚未在CHF患者中研究其对心脏功能的影响。这促使我们研究与安慰剂治疗相比，利拉鲁肽治疗24周是否能改善合并或不合并T2D的CHF患者的左心室射血分数（LVEF）。
一项由研究者发起的、多中心、随机、双盲、平行、安慰剂对照干预试验。总共240例LVEF≤45%的CHF患者（合并或不合并T2D）将被随机分为皮下注射1.8mg利拉鲁肽或匹配的安慰剂，每日一次，共24周。利拉鲁肽对左心室功能的影响将通过先进的超声心动图进行评估，包括三维对比超声心动图。
该研究将根据《药物临床试验质量管理规范-国际协调会议》（GCP-ICH）法规进行实施和监测，并按照《赫尔辛基宣言》的原则开展。丹麦药品管理局、当地研究伦理委员会和丹麦数据保护局已批准该研究。
ClinicalTrials.gov标识符：NCT01472640。
