Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)

Phase 3

Not yet recruiting

• Conditions: Acute Decompensated Heart Failure
• Interventions: Device: Reprieve System; Drug: furosemide infusion

• Registration Number: NCT06898515
• Lead Sponsor: Reprieve Cardiovascular, Inc

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-10
• Study First Submitted QC: 2025-03-25
• Study First Posted: 2025-03-27
• Status Verified: 2025-05
• Study Start: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-13
• Primary Completion: 2027-08
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. 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
2. ≥10 lb. (4.5 kg) above dry weight as estimated by health care provider.
3. Current outpatient prescription for daily loop diuretic.
4. Participants ≥ 22 years of age able to provide informed consent and comply with study procedures.
5. 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

Exclusion Criteria

1. 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.
2. 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.
3. Uncontrolled arrhythmias defined as sustained HR >130 beats/min for >10 minutes within the past 48 hours.
4. Severe lung disease with chronic home oxygen requirement >2L/min.
5. Acute infection with evidence of systemic involvement (e.g., clinically suspected infection with fever or elevated serum white blood cell count).
6. 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).
7. 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.
8. 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.
9. 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.
10. 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
11. Currently enrolled in an interventional trial (observational studies are permitted).
12. Life expectancy less than 6 months.
13. Women who are pregnant or breastfeeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reprieve System	Reprieve System	Participants randomized to Reprieve System will receive personalized and optimized diuretic and saline infusion using the study device during the course of the treatment.
Optimal Diuretic Therapy (ODT)	furosemide infusion	Participants randomized to ODT will be treated with guided diuretic titration, as recommended in the ESC guidelines on diuretic therapy

Primary Outcome Measures

Name	Time	Method
Hierarchical composite/win-ratio	1. up to 30 days from randomization, 2. up to 30 days from discharge, 3. up to 72 hours from the end of randomized therapy, 4. up to 72 hours after randomization	1. Freedom from 30-day CV mortality; 2. Freedom from HF Rehospitalization 30 days post-discharge; 3. Freedom from AKI, through 72 hours post-randomized therapy (KDIGO stage 2 or greater: ≥ doubling of serum creatinine or use of RRT); 4. Greater net sodium loss per 24 hours during treatment

Secondary Outcome Measures

Name	Time	Method
CV mortality and cumulative HF rehospitalizations	90 days after hospital discharge	Both types of events will be combined in a total "event rate" compared between groups
Time on IV diuretic therapy	randomization through hospital discharge, assessed up to 30 days
Net sodium loss	per 24 hours at end of randomized therapy
Net fluid loss	per 24 hours at end of randomized therapy	Fluid input subtracted from total urine output
Weight loss	per 24 hours at end of randomized therapy
Significant acute kidney injury defined as KDIGO stage 2 or greater AKI [≥ doubling of serum creatinine or use of renal replacement therapy]	initiation of randomized therapy up to 72 hours after stopping randomized therapy
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	serum potassium \<3.0 mEq/L with ≥ 0.5 mEq/L decrease from initiation of randomized therapy, magnesium \<1.3 mEq/L with ≥0.5 mEq/L decrease from initiation of randomized therapy, or sodium \<125 mEq/L with ≥ 5.0 mEq/L decrease from initiation of 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

Trial Locations

Locations (11)

University of California Irvine; 🇺🇸 Irvine, California, United States

Trinity Health Ann Arbor Hospital; 🇺🇸 Ann Arbor, Michigan, United States

St. Louis VA; 🇺🇸 St. Louis, Missouri, United States

Washington University; 🇺🇸 St. Louis, Missouri, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Lindner Center at Christ Hospital; 🇺🇸 Cincinnati, Ohio, United States

Ohio State University Hospital; 🇺🇸 Columbus, Ohio, United States

Prisma Health Greenville Memorial Hospital; 🇺🇸 Greenville, South Carolina, United States

Moses H. Cone Memorial Hospital; 🇺🇸 Greensboro, North Carolina, United States

Atrium Health Wake Forest Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States

Baylor Scott and White; 🇺🇸 Dallas, Texas, United States