2023-504731-40-01招募中4 期
EMPagliflozin after Aortic Valve Replacement - the EMPAVR study - a randomized clinical trial
Rigshospitalet, Rigshospitalet1 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2023年11月8日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 206
- 试验地点
- 1
- 主要终点
- Change in left ventricular mass indexed to body surface area (measured by CT) from pre aortic valve replacement (AVR) to 12-months post-AVR
研究概览
简要总结
The purpose of this trial is to test whether SGLT2 inhibition after AVR is superior to placebo in reducing left ventricular mass and improve patient symptoms.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Severe symptomatic AS AND Surgical or transcatheter AVR within 14 days
排除标准
- •Prior treatment with an SGLT2i
- •eGFR <30ml/min
- •Hypersensitivity to empagliflozin or placebo tablet
结局指标
主要结局
Change in left ventricular mass indexed to body surface area (measured by CT) from pre aortic valve replacement (AVR) to 12-months post-AVR
Change in left ventricular mass indexed to body surface area (measured by CT) from pre aortic valve replacement (AVR) to 12-months post-AVR
次要结局
- Left ventricular end-systolic volume indexed to body surface are (LVESVi measured by CT)
- Left ventricular global longitudinal strain (LV GLS) (measured by echo)
- NT-proBNP change from baseline to 12 months
- Composite of death and readmission for any non-planned cause
研究者
Emil Fosbøl
Scientific
Rigshospitalet
研究点 (1)
Loading locations...
相似试验
已完成
4 期
EMPagliflozin After Aortic Valve ReplacementAortic Valve StenosisNCT06171802Rigshospitalet, Denmark206
招募中
1 期
EMPagliflozin after Aortic Valve Replacement - the EMPAVR studyAortic stenosisCTIS2023-504731-40-01Rigshospitalet206
已完成
4 期
Dapagliflozin After Transcatheter Aortic Valve ImplantationTranscatether Aortic Valve ImplantationAortic StenosisNCT04696185Spanish Society of Cardiology1,257
招募中
2 期
Monocentric Pilot Trial evaluating the safety and efficacy of Regorafenib in Arterio-Venous Malformations that are refractory to standard care2022-501830-47-01Cliniques Universitaires Saint-Luc10
招募中
2 期
A Phase 2 Randomized Trial Evaluating Efficacy of AGA2118 in Postmenopausal Women with Low Bone Mass (ARTEMIS)Postmenopausal Osteoporosis2024-515610-41-00Angitia Inc. Ltd.260