EU Sites: Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS) (FASTR-EU)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Total sodium loss (in mmol of sodium) per 24 hours
研究概览
简要总结
The objective of this study is to prospectively compare decongestive therapy administered by the Reprieve DMS system to Optimal Diuretic Therapy (ODT) in the treatment of patients diagnosed with acute decompensated heart failure (ADHF). The main objective is to determine if the Reprieve DMS is non-inferior to state-of-the-art urine sodium guided aggressive diuretic titration in two European HF centers of excellence.
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
- •Hospitalized with a diagnosis of heart failure as defined by the presence of at least 1 symptom AND 1 sign.
- •≥10 pounds (4.5 kg) above dry weight either by historical weights or as estimated by health care provider.
- •Prior use of loop diuretics within 30 says prior to admission.
- •≥ 18 years of age able to provide informed consent and comply with study procedures.
排除标准
- •Inability to place Foley catheter or IV catheter.
- •Hemodynamic instability.
- •Dyspnea due primarily to non-cardiac causes.
- •Acute infection with evidence of systemic involvement.
- •Estimated glomerular filtration rate (eGFR) < 20 ml/min/1.73m2 calculated using the MDRD equation or current use of renal replacement therapy.
- •Significant left ventricular outflow obstruction, uncorrected complex congenital heart disease, severe stenotic valvular disease, infiltrative or constrictive cardiomyopathy, acute myocarditis, type 1 acute myocardial infarction requiring treatment, or any other pathology that, in the opinion of the investigator, would make aggressive diuresis poorly tolerated.
- •Inability to follow instructions or comply with follow-up procedures.
- •Other concomitant disease or condition that investigator deems unsuitable for the study, including drug or alcohol abuse or psychiatric, behavioral or cognitive disorders, sufficient to interfere with the patient's ability to understand and comply with the study instructions or follow-up procedures.
- •Severe electrolyte abnormalities.
- •Presence of active coronavirus disease 2019 (COVID-19) infection.
- •Enrollment in another interventional trial during the index hospitalization.
- •Inability to return for follow-up study visits.
- •Life expectancy less than 3 months.
- •Women who are pregnant or intend to become pregnant.
研究组 & 干预措施
Reprieve Decongestion Management System
Subjects randomized to Reprieve System will receive personalized and optimized diuretic and saline infusion using the study device during the course of the treatment.
干预措施: Reprieve Decongestion Management System (Device)
Optimal Diuretic Therapy
Sites will consider best practices of optimal diuretic dosing such as those demonstrated in recent randomized trials [Diuretic Strategies in Patients with Acute Heart Failure Trail (DOSE), Acetazolamide in Decompensated Heart Failure with Volume Overload Trial (ADVOR), and Safety and Efficacy of the Combination of Loop with Thiazide-type Diuretics in Patients with Decompensated Heart Failure Trial (CLOROTIC)] for patients randomized to control arm of the trial.
干预措施: Diuretic (furosemide, bumetanide, torsemide, hydrochlorothiazide, and/or acetazolamide) (Drug)
结局指标
主要结局
Total sodium loss (in mmol of sodium) per 24 hours
时间窗: End of treatment, an average of 72 hours
Primary efficacy endpoint is total sodium loss in mmol of sodium at end of randomized therapy normalized to 24 hours (up to a maximum of 72 hours).
Comparison of occurrence of composite endpoint comprised of clinically significant acute kidney injury, severe electrolyte abnormality, or symptomatic hypotension or hypertensive emergency.
时间窗: Through study completion, an average of 90 days
Primary safety endpoint is positive if any of the following occurs in an individual participant: 1. Clinically significant acute kidney injury defined as Kidney Disease-Improving Global Outcomes (KDIGO) stage 2 or greater Acute Kidney Injury (AKI) \[≥ doubling of baseline serum creatinine or use of renal replacement therapy (RRT)\] 2. Severe electrolyte abnormality defined as serum potassium \<3.0 milliequivalent/liter (mEq/L), magnesium \<1.3 mEq/L, or sodium \<135 mEq 3. Symptomatic hypotension (systolic pressure \<80mmHg) or hypertensive (systolic pressure \>200 mmHg and/or diastolic pressure \>120 mmHg) emergency.
次要结局
- Time on IV loop diuretic(End of treatment, an average of 72 hours)
- Total net fluid volume loss (difference between urine output volume and fluid input volume) per 24 hours(End of treatment, an average of 72 hours)
- Weight loss per 24 hours at end of randomized therapy(End of treatment, an average of 72 hours)
- Number of participants with ≥ 0.3 mg/dL increase in serum creatinine(End of treatment, an average of 72 hours)