Dapagliflozin After Transcatheter Aortic Valve Implantation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,257
- 试验地点
- 40
- 主要终点
- Incidence rate of the composite of all-cause mortality or worsening heart failure (HF)
研究概览
简要总结
Pragmatic, controlled, prospective, randomized, open-label (open-label), evaluator-blind clinical trial (PROBE design) that will analyze the benefits of dapagliflozin treatment in patients with severe aortic stenosis discharged after implantation of an aortic valve prosthesis transcatheter (TAVI).
详细描述
Patients discharged after TAVI, with a history of heart failure (HF) plus depressed left ventricular ejection fraction (LVEF ≤ 40%) or diabetes mellitus (DM) or glomerular filtration rate (GFR) between 25 and 75 ml/min/1.73 m2, will be randomized (1:1) before hospital discharge to receive treatment with dapagliflozin 10 mg/day or no dapagliflozin (no placebo).
Only variables available during routine clinical practice will be collected and there will be no additional tests.
The incidence of clinical events and adherence to the dapagliflozin arm will be documented at 2 time-points (3 ± 1 months and 12 months) by phone calls and review of medical records.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
All events will be adjudicated by the Clinical Events Adjudication Committee (CEAC), without information about the therapy (intervention or control) (blinded endpoint)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SEVERE AORTIC STENOSIS UNDERWENT TAVI
- •PRIOR HEART FAILURE ADMISSION AND ONE OF THE FOLLOWING CRITERIA:
- •Left ventricular ejection fraction ≤ 40% or
- •Diabetes mellitus or
- •Estimated glomerular filtrate rate 25-75 ml/min/1.73 m2
排除标准
- •Known allergy or intolerance to SGLT2 inhibitors.
- •Concomitant therapy with sulfonylurea or SGLT2 inhibitors..
- •Systolic blood pressure < 100 mmHg or diastolic blood pressure < 50 mmHg.
- •An estimated glomerular filtration rate (GFR) below 25 ml per minute per 1.73 m
- •Chronic cystitis and/or recurrent urinary tract infections (2 or more in the last year)
- •Poor control of diabetes mellitus that requires SGLT-2 inhibitor prescription on discharge according to treating physician judge.
- •Any medical condition that, in the investigator´s judgment, would seriously limit life expectancy (less than one year).
- •Pregnant or breast-feeding patients
- •Patients participating in other clinical trials.
研究组 & 干预措施
Dapagliflozin
Sodium-glucose cotransporter-2 (SGLT-2) inhibitor therapy with daily oral dose of dapagliflozin 10 mg
干预措施: Dapagliflozin 10 MG (Drug)
结局指标
主要结局
Incidence rate of the composite of all-cause mortality or worsening heart failure (HF)
时间窗: 1 year
All-cause mortality and worsening HF (including hospitalization for HF or an urgent visit resulting in intravenous therapy for HF).
次要结局
- Incidence rate all-cause mortality(1 year)
- Incidence rate of Hospitalization for Heart Failure(1 year)
- Incidence rate of Urgent Heart Failure visits(1 year)
- Total number of Heart Failure hospitalizations and Cardiovascular deaths(1 year)
- Incidence rate of the composite of Heart Failure hospitalization or Cardiovascular death(1 year)
- Incidence rate of Cardiovascular death(1 year)
研究者
SERGIO RAPOSEIRAS ROUBIN
Principal Investigator
Spanish Society of Cardiology