EUCTR2018-002614-12-ES进行中（未招募）1 期
Short-term Effects of Dapagliflozin on Peak VO2 in Patients with Heart Failure with Reduced Ejection Fraction and Type 2 Diabetes
Instituto de Investigación Sanitaria INCLIVA0 个研究点目标入组 90 人开始时间: 2019年1月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-The participant or his legal representative is willing and able to give informed consent for participation in the study.
- •- Male or female, aged =18 years.
- •- Established documented diagnosis of symptomatic HF (NYHA functional class II-III), which has been present for at least 2 months.
- •- LVEF =40% documented in the last 3 months by echocardiography or cardiac magnetic resonance.
- •- Established diagnosis of type 2 diabetes.
- •- NT-proBNP =600 pg/ml.
- •- Patients should receive background standard of care for HFrEF at judgment of the investigator.
- •- Estimated glomerular filtration rate (eGFR) =30 ml/min/1.73m2 (DMRD formula) at enrolment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •- Patients receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment, or previous intolerance of an SGLT2 inhibitor.
- •- Type 1 diabetes.
- •- Symptomatic hypotension or systolic blood pressure <95 mmHg.
- •- Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment.
- •- Myocardial infarction, unstable angina, stroke, or transient ischemic attack within 12 weeks prior to enrolment.
- •- Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or cardiac valve repair/replacement within 12 weeks prior to enrolment, or planned to undergo any of these operations after randomization.
- •- Implantation of a cardiac resynchronization therapy (CRT) device within 12 weeks prior to enrolment or intent to implant a CRT device.
- •- Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization.
- •- HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy, or uncorrected severe primary cardiac valve disease.
- •- Symptomatic bradycardia or second or third-degree heart block without a pacemaker.
- •- Severe renal dysfunction (eGFR<30 ml/min/1.73m2) or prior admission for acute renal failure in the last 4 weeks.
- •- Pregnant or lactating women.
- •- Woman of childbearing age, unless they are using highly effective contraceptive methods.
- •- Patients with severe hepatic impairment (Child-Pugh class C).
研究者
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