ACTRN12621000187842尚未招募2 期
Mechanisms of action of SGLT2 inhibitors in patients with heart failure with reduced ejection fraction (HFrEF)
The Alfred Hospital0 个研究点目标入组 36 人开始时间: 2021年2月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
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 70 Years(—)
- 性别
- All
入选标准
- •LVEF less than or equal to 40%. NYHA II-IV.
- •Ischaemic or non-Ischaemic aetiology.
- •Stable heart failure therapy for 1 month (a <50% adjustment to diuretics is permissible between day -14 and day -28).
- •Patients may be non-diabetic or T2DM (on stable therapy >12 weeks defined as < ±20% variability in the average daily dose or oral agents and/or < ±10% daily variability in insulin dose).
排除标准
- •Unstable heart failure or haemodynamics (eg SBP<90mmHg, poorly controlled AF – rate>90/min). Recent or active unstable coronary disease in the past 2 months or PCI with the past month or CABG within 3 months.
- •Type 1 diabetes.
- •Poorly controlled BSL (fasting plasma glucose level > 13.3 mmol/L).
- •History of ketoacidosis or hyperosmolar state/coma within 6 months.
- •Ongoing therapy with an SGLT2 inhibitor or GLP-1 receptor agonist.
- •On monoamine oxidase inhibitors or tricyclic antidepressants.
- •Body mass index (BMI) <20.0 kg/m2 or >40 kg/m2.
- •eGFR <30 ml/min/1.73 m2.
- •Other life limiting lesion (expected survival <2 years) including malignancy, advanced respiratory, GI, neurologic, haematologic disease. Active substance abuse including EtOH.
- •Inability to provide written informed consent.
研究者
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