Clinical trial NCT06898515: Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)
Official title: Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Acute Decompensated Heart Failure
Lead sponsor: Reprieve Cardiovascular, Inc
Sponsor class: INDUSTRY
First posted: 2025-03-27
Enrollment: 400
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Hierarchical composite/win-ratio
timeFrame: 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
Secondary outcomes:
measure: CV mortality and cumulative HF rehospitalizations
timeFrame: 90 days after hospital discharge
measure: Time on IV diuretic therapy
timeFrame: randomization through hospital discharge, assessed up to 30 days
measure: Net sodium loss
timeFrame: per 24 hours at end of randomized therapy
measure: Net fluid loss
timeFrame: per 24 hours at end of randomized therapy
measure: Weight loss
timeFrame: per 24 hours at end of randomized therapy
measure: Significant acute kidney injury defined as KDIGO stage 2 or greater AKI [≥ doubling of serum creatinine or use of renal replacement therapy]
timeFrame: initiation of randomized therapy up to 72 hours after stopping randomized therapy
measure: 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.
timeFrame: initiation of randomized therapy up to 12 hours after stopping randomized therapy
measure: Severe electrolyte abnormality
timeFrame: initiation of randomized therapy up to 72 hours after stopping randomized therapy
measure: Worsening heart failure requiring a higher level of HF therapy
timeFrame: initiation of randomized therapy up to 72 hours after stopping randomized therapy
measure: Tinnitus or hearing loss lasting more than 30 minutes
timeFrame: initiation of randomized therapy up to 12 hours after stopping randomized therapy
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California Irvine
state: California
city: Ann Arbor
country: United States
facility: Trinity Health Ann Arbor Hospital
state: Michigan
city: St. Louis
country: United States
facility: St. Louis VA
state: Missouri
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Greensboro
country: United States
facility: Moses H. Cone Memorial Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Lindner Center at Christ Hospital
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Hospital
state: Ohio
city: Greenville
country: United States
facility: Prisma Health Greenville Memorial Hospital
state: South Carolina
city: Dallas
country: United States
facility: Baylor Scott and White
state: Texas
Study officials:
affiliation: Baylor Scott and White Health
name: Javed Butler, MD, MPH, MBA
role: PRINCIPAL_INVESTIGATOR
References: