NCT06898515招募中3 期
Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 53
- 主要终点
- Hierarchical composite/win-ratio
研究概览
简要总结
The objective of this study is to prospectively compare decongestive therapy administered by the Reprieve 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 System 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of HF with expected hospitalization >24 hours, with >1 new or worsening symptom and >2 physical examination, laboratory, or invasive findings of HF, and receiving or with plans to receive a HF-specific treatment
- •≥10 lb. (4.5 kg) above dry weight as estimated by health care provider.
- •Current outpatient prescription for daily loop diuretic.
- •Participants ≥ 22 years of age able to provide informed consent and comply with study procedures.
- •Elevated risk of diuretic resistance, as indicated by at least one of the following: Baseline hypochloremia OR Urine output <1L in the 6 hours following IV loop diuretic >=40 mg furosemide equivalent OR Spot urine sodium <100 mmol/L 1-2 hours after IV loop diuretic >= 40 mg furosemide equivalent
排除标准
- •Urologic issues that would predispose the participant to a high rate of urogenital trauma or infection with catheter placement or known inability to place a Foley catheter.
- •Hemodynamic instability as defined by any of the following: sustained systolic blood pressure <90 mmHg for >15 minutes within the past 48 hours, use of IV vasopressors or inotropes within past 48 hours, and/or current or previous mechanical circulatory support within the last week.
- •Uncontrolled arrhythmias defined as sustained HR >130 beats/min for >10 minutes within the past 48 hours.
- •Severe lung disease with chronic home oxygen requirement >2L/min.
- •Acute infection with evidence of systemic involvement (e.g., clinically suspected infection with fever or elevated serum white blood cell count).
- •Estimated glomerular filtration rate (eGFR) <25 ml/min/1.73m2 (calculated with either MDRD or CKD-EPI) or current use of renal replacement therapy (RRT).
- •Significant left ventricular outflow obstruction, severe uncorrected complex congenital heart disease, known severe stenotic valvular disease, severe infiltrative or constrictive cardiomyopathy or other diagnosis that would make aggressive decongestion unsafe.
- •Current or recent (< 30 days) type I myocardial infarction (e.g., acute coronary syndrome such as NSTEMI or STEMI from plaque rupture), coronary artery bypass surgery, or stroke. An isolated troponin elevation (e.g., from volume overload or demand ischemia) is not a reason for exclusion.
- •Severe electrolyte abnormalities (e.g., serum potassium <3.0 mEq/L, magnesium <1.3 mEq/L or sodium <125 mEq/L). Note: These are based on baseline/screening labs. Participants whose electrolyte levels are repleted cannot be reassessed for inclusion in the trial.
- •Other concomitant disease or condition the investigator believes will make it difficult to follow instructions or comply with study procedures and/or follow-up visits, including expected prolonged hospitalization for reasons other than decongestive therapy
- •Currently enrolled in an interventional trial (observational studies are permitted).
- •Life expectancy less than 6 months.
- •Women who are pregnant or breastfeeding.
研究组 & 干预措施
Reprieve System
Experimental
Participants 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 System (Device)
Optimal Diuretic Therapy (ODT)
Active Comparator
Participants randomized to ODT will be treated with guided diuretic titration, as recommended in the ESC guidelines on diuretic therapy
干预措施: furosemide infusion (Drug)
结局指标
主要结局
Hierarchical composite/win-ratio
时间窗: 1. up to 30 days from randomization, 2. up to 30 days from discharge, 3. up to 72 hours after randomization
1. Freedom from 30-day CV mortality 2. Freedom from HF Rehospitalization 30 days post-discharge 3. Greater net sodium loss per 24 hours during treatment
Incidence of device/procedure-related adverse events (KDIGO stage 2 or greater AKI, CAUTI)
时间窗: initiation of randomized therapy through 72 hours following completion of randomized therapy
KDIGO stage 2 or greater AKI: ≥ doubling of serum creatinine or use of renal replacement therapy; CAUTI per CDC definition
次要结局
- Net sodium loss(per 24 hours at end of randomized therapy)
- Time to discharge readiness(through hospital discharge, an average of 5 days)
- Time on IV diuretic therapy(randomization through hospital discharge, assessed up to 30 days)
- Net fluid loss(per 24 hours at end of randomized therapy)
- Weight loss(per 24 hours at end of randomized therapy)
- CV mortality and cumulative HF rehospitalizations(90 days after hospital discharge)
- Length of stay(through hospital discharge, an average of 5 days)
- Hypotension defined as systolic blood pressure < 80 mmHg documented with two readings at least 30 minutes apart with symptoms (e.g., chest pain, dizziness) or <80 mmHg requiring an intervention including IV fluids or vasopressors.(initiation of randomized therapy up to 12 hours after stopping randomized therapy)
- Severe electrolyte abnormality(initiation of randomized therapy up to 72 hours after stopping randomized therapy)
- Worsening heart failure requiring a higher level of HF therapy(initiation of randomized therapy up to 72 hours after stopping randomized therapy)
- Tinnitus or hearing loss lasting more than 30 minutes(initiation of randomized therapy up to 12 hours after stopping randomized therapy)
研究者
研究点 (53)
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