NCT05318105终止不适用
A Randomized Controlled Study to Evaluate the Safety and Effectiveness of the Aquadex System in Patients With Heart Failure and Fluid Overload
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 167
- 试验地点
- 29
- 主要终点
- Time to first heart failure (HF) event
研究概览
简要总结
The REVERSE-HF study is a randomized controlled trial to evaluate clinical outcomes of adjustable ultrafiltration with the Aquadex System as compared to adjustable IV loop diuretics in patients with worsening heart failure (HF) and fluid overload.
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
- None
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
- •18 years or older
- •Man, or non-pregnant woman
- •Admitted to the hospital with a diagnosis of acute decompensated heart failure
- •On regularly prescribed oral loop diuretics, Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors or a Mineralcorticoid Receptor Antagonists (MRA) prior to admission
- •Fluid overload manifested by at least three clinical indications (e.g., edema, an excess of at least 10 pounds of fluid, etc.)
- •Provide written informed consent
排除标准
- •New diagnosis of heart failure
- •Acute coronary syndromes
- •Creatinine ≥ 3.0 mg/dl or planned renal replacement therapies at the time of enrollment
- •Contraindications to systemic anticoagulation
- •Severe concomitant disease expected to prolong hospitalization or cause death in less than 90 days
- •Sepsis or ongoing systemic infection
- •Active myocarditis
- •Constrictive pericarditis or restrictive cardiomyopathy
- •Severe aortic stenosis
- •Any condition in the opinion of the investigator that would prevent the patient from follow-up/survival
研究组 & 干预措施
Aquadex ultrafiltration therapy
Experimental
干预措施: Aquadex Smartflow® System (Device)
IV loop diuretics
Active Comparator
干预措施: IV Loop Diuretics (Drug)
结局指标
主要结局
Time to first heart failure (HF) event
时间窗: within 30 days
Heart Failure (HF) event defined as any HF rehospitalization or unplanned use of IV loop diuretics, vasoactive medications or Aquadex therapy in any outpatient setting.
次要结局
- Win ratio analysis(within 30 days)
研究者
研究点 (29)
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