SGLT2-inhibitor : Acute Effects Crossover Trial (SAECT)Acute effects of SGLT2-inhibitor in type II diabetics with heart failure with reduced ejection fraction (HFrEF) on 6-minute walk test distance

Flinders Medical Centre0 个研究点目标入组 25 人开始时间: 2018年12月10日最近更新: 2019年1月7日

适应症

试验速览

暂无简介。

•Patients with previously diagnosed T2DM for which they are on prescribed glucose lowering therapy.
•Admission with an episode of decompensated heart failure.
•Heart failure with reduced ejection fraction (HFrEF) (documented EF <=40%)
•Qualify for add on SGLT2 inhibitor glucose lowering therapy for DM according to current guidelines
•Patients who are being prescribed an add-on SGLT2 inhibitor (long term) by the responsible hospital medical team on the basis of their medical judgment (independent of the trial) for the approved PBS indication of suboptimal glycaemic control.
•On guideline-recommended therapy for their heart failure (or documented reason why not)
•Clinically stable at the time of recruitment
•Live within a geographically accessible area for follow-up

•Age less than 18 years
•Unable to provide written informed consent to participate in the study (this includes the inability to communicate fluently with the investigator and cognitive incompetence)
•Valvular stenosis of > moderate severity
•Valvular regurgitation >=severe and planning corrective invasive therapy
•Oncologic (or other) life expectancy <12 months or any other medical condition (including pregnancy) that results in the belief (deemed by the Chief Investigators) that it is not medically appropriate for the patient to participate in this trial
•eGFR <60 ml/min/1.73m2
•Past history of ketoacidosis
•Past history of frequent or significant genital candidiasis
•Already taking or past intolerance to an SGLT2 inhibitor
•Pregnant, breastfeeding or women of child bearing potential without adequate contraception
•Elective surgery in the next 8 weeks

发起方