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临床试验/ACTRN12621000187842
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

发起方
The Alfred Hospital

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