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临床试验/NCT04200586
NCT04200586Unknown4 期

The Effects of SGLT Inhibition on Diabetic Cardiomyopathy

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年4月9日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
30
试验地点
1
主要终点
Change in myocardial perfusion reserve index

研究概览

简要总结

Diabetic cardiomyopathy is associated with significant morbidity and mortality. It is considered as a cardiac muscle disorder secondary to diabetes mellitus (DM). Certain studies show the clinical benefit of SGLT-s inhibitors on reducing cardiovascular outcomes amongst patients with type II DM that go beyond the correction of hyperglycemic perse. Thus an observational imaging study is proposed to identify mechanistic insights of the drug group over cardiovascular events.

详细描述

Diabetic cardiomyopathy is defined as ventricular dysfunction in diabetic patients in the absence of coronary artery disease and hypertension. It is considered as a cardiac muscle disorder due to the metabolic consequences of DM characterized by left ventricular hypertrophy, left ventricular diastolic dysfunction (in the early stage), and/or systolic dysfunction. To date, there is no specific treatment proven effective for the condition due to the incomplete understanding of the pathogenesis.

Recent studies however prove the efficacy of SGLT-2 inhibitors on reducing the primary composite end point of cardiovascular outcomes including hospitalization for heart failure, cardiovascular death, and all-cause death amongst patients with type II DM. Such clinical benefit is apparently mainly stemmed from the reduction in heart failure related mortality and sudden cardiac death rather than the macro-vascular events such as myocardial infarct and stroke, suggesting addition benefits going beyond the correction of hyperglycemia perse. These studies thus raise the possibility that the drug may have direct effects on the myocardium that conferring the clinical benefit not related the modification of traditional risk factors such as glycemic control, lipid, blood pressure, and obesity.

A single-arm, observational cardiac magnetic resonance imaging study is proposed in type II diabetic patients before and 2 months after initiation of dapagliflozin. The aim is to identify mechanistic insights leading to the unexpected clinical benefit of SGLT inhibition.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • type 2 diabetes
  • 40-90 years old
  • HbA1c >= 6.5%
  • history of heart failure with reduced ejection fraction
  • indications for SGLT inhibition on clinical ground

排除标准

  • angina pectoris or chest discomfort
  • prior coronary artery bypass grafts
  • coronary artery stenting within 6 months of study enrolment
  • pervious myocardial infarct
  • any contraindication for stress CMR testing
  • renal impairment with eGFR <45ml/min/1.73m2
  • limited life expectancy <5 years, for example due to pulmonary disease, cancer or
  • significant hepatic failure
  • contraindication to dapagliflozin or other SGLT2 inhibitors
  • unable to take dapagliflozin
  • patients currently on and SGLT2 inhibitor
  • planned need for concomitant cardiac surgery or coronary intervention
  • refusal or inability to sign an informed consent
  • potential for on-compliance towards the requirements in the trial protocol (especially the medical treatment) or follow-up visits

研究组 & 干预措施

Dapagliflozin

Experimental

Dapagliflozin, one of the SGLT-2 inhibitors, will be prescribed to DM patients on clinical ground

干预措施: Dapagliflozin (Drug)

结局指标

主要结局

Change in myocardial perfusion reserve index

时间窗: 8-12 weeks

Change in myocardial perfusion reserve index calculated from cardiac MRI

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Chung-Wah David SIU

Clinical Professor

The University of Hong Kong

研究点 (1)

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