Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS) - FASTR Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 32
- 主要终点
- Total urine sodium output
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 can more efficiently decongest ADHF patients in comparison to Control Therapy.
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
Optimal Diuretic Therapy
Sites will consider best practices of optimal diuretic dosing such as those demonstrated in recent randomized trials (DOSE, ADVOR, CLOROTIC) for patients randomized to control arm of the trial.
干预措施: Diuretic (Drug)
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)
结局指标
主要结局
Total urine sodium output
时间窗: 24 hours post-treatment initiation
Primary efficacy endpoint is total urine sodium output at 24 hours post-treatment initiation.
Clinically significant acute kidney injury, severe electrolyte abnormality, symptomatic hypotension or hypertensive emergency.
时间窗: Through study completion, an average of 90 days
Primary safety endpoint includes clinically significant acute kidney injury defined as KDIGO stage 2 or greater AKI \[≥ doubling of baseline serum creatinine or use of renal replacement therapy (RRT)\], severe electrolyte abnormality (serum potassium \<3.0 mEq/L, magnesium \<1.3 mEq/L or sodium \<125 mEq), symptomatic hypotension or hypertensive emergency.
次要结局
- Net fluid loss(End of treatment, an average of 72 hours)
- Time on loop diuretics(End of treatment, an average of 72 hours)