ACTRN12620001256965进行中（未招募）2 期
Chronic Myocardial Injury-Evaluating The Possible Role Of SGLT-2 Inhibition. A phase II multicentre double blind randomised parallel group comparison of 10mg dapagliflozin versus placebo over 6 months in chronic myocardial injury
Flinders University of South Australia0 个研究点目标入组 30 人开始时间: 2020年11月24日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Patients will be considered eligible if they meet all of the following:
- •1. Chronic elevation of defined as a troponin T velocity of <3ng/L/hour assessed with at least 3 troponin values measued, with at least 2 of these being 4 hours apart, AND with at least 1 of these values >14ng/L, within the first 24 hours of initial presentation;
- •2. Age of 18 years or older;
- •3. Willing to give informed consent
排除标准
- •Patients will be considered ineligible if they meet any of the following:
- •1.Troponin T: Maximal in hospital troponin level >100ng/L within the first 24 hours of initial presentation or acute myocardial injury, defined as a rise and/or fall in troponin T with a velocity of >3ng/L/hr;
- •2.Recent coronary revascularization (PCI and CABG) within the last 6 months
- •3.Active heart failure with clinical symptoms of dyspnoea or extra-vascular volume overload and a NT-proBNP level >500ng/L;
- •4.Treated diabetes, defined as receiving any long-term/chronic oral or parenteral pharmacotherapies for the treatment of established diabetes;
- •5.Renal impairment with a documented eGFR of <45ml/min/1.73m2;
- •6.Documented HBA1C level >7% in the previous 3 months;
- •7.Presentation with documented ST segment elevation on ECG representing either ST-segment elevation MI or pericarditis;
- •8.Documented pulmonary embolus or aortic dissection;
- •9.History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time;
- •10.Recurrent genital infections;
- •11.Pregnancy or breast-feeding (female), planning to donate sperm (male) or trying to conceive within the next 6 months (males and females);
- •12.History of allergy to SGLT2 inhibitors or similar drug
- •13.Concurrent participation in another randomized clinical trial;
- •14.Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)
- •15.Previous enrolment or randomisation in the present study
- •16.Currently taking an SGLT2 inhibitor or previous treatment with SGLT2 inhibitor in the last 6 months
研究者
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