The Effects of SGLTi on Diabetic Cardiomyopathy (SGLTi)
The Effects of SGLT Inhibition on Diabetic Cardiomyopathy
研究概览
详细说明
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.
研究类型
注册 (预期的)
阶段
- 第四阶段
联系人和位置
学习地点
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Hong Kong、香港
- Queen Mary Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Dapagliflozin
Dapagliflozin, one of the SGLT-2 inhibitors, will be prescribed to DM patients on clinical ground
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Dapagliflozin, one of the SGLT-2 inhibitors, will be prescribed to DM patients on clinical ground.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in myocardial perfusion reserve index
大体时间:8-12 weeks
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Change in myocardial perfusion reserve index calculated from cardiac MRI
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8-12 weeks
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合作者和调查者
调查人员
- 首席研究员:David Chung-Wah SIU, Prof、The University of Hong Kong
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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