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)

Overview

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.

Interventions

• Device Reprieve System
  The Reprieve System is a hospital bedside fluid management console designed to provide personalized and automated infusion of the IV diuretic furosemide and physiological saline in response to the patient's real-time urine output to safely and rapidly decongest patients suffering from Acute Decompensated Heart Failure.
• Drug 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

• Hierarchical composite/win-ratio [Time frame: 1. up to 30 days from randomization, 2. up to 30 days from discharge, 3. up to 72 hours after randomization]
• Incidence of device/procedure-related adverse events (KDIGO stage 2 or greater AKI, CAUTI) [Time frame: initiation of randomized therapy through 72 hours following completion of randomized therapy]

Secondary outcome measures (11)

• Net sodium loss [Time frame: per 24 hours at end of randomized therapy]
• Time to discharge readiness [Time frame: through hospital discharge, an average of 5 days]
• Time on IV diuretic therapy [Time frame: randomization through hospital discharge, assessed up to 30 days]
• Net fluid loss [Time frame: per 24 hours at end of randomized therapy]
• Weight loss [Time frame: per 24 hours at end of randomized therapy]
• CV mortality and cumulative HF rehospitalizations [Time frame: 90 days after hospital discharge]
• Length of stay [Time frame: 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. [Time frame: initiation of randomized therapy up to 12 hours after stopping randomized therapy]
• Severe electrolyte abnormality [Time frame: initiation of randomized therapy up to 72 hours after stopping randomized therapy]
• Worsening heart failure requiring a higher level of HF therapy [Time frame: initiation of randomized therapy up to 72 hours after stopping randomized therapy]
• Tinnitus or hearing loss lasting more than 30 minutes [Time frame: initiation of randomized therapy up to 12 hours after stopping randomized therapy]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 37 centers

• University of California Irvine — Irvine
• Scripps Memorial Hospital — La Jolla
• UC Davis Medical Center — Sacramento
• University of Florida — Gainesville
• Piedmont Atlanta Hospital — Atlanta
• Piedmont Augusta Hospital — Augusta
• Northeast Georgia Medical Center — Gainesville
• Advocate Christ Medical Center — Oak Lawn
• … and 29 more centers

Spain · 6 centers

• Vall d'Hebron University Hospital — Barcelona
• Hospital de Bellvitge — Barcelona
• Hospital Ramon y Cajal — Madrid
• Puerta de Hierro Majadahonda University Hospital — Madrid
• Clínico Universitario de Valencia — Valencia
• Hospital General Valencia — Valencia

Germany · 4 centers

• Universitätsklinikum Gießen (UKGM) — Giessen
• Hannover University Hospital — Hanover
• University Hospital Heidelberg — Heidelberg
• Jena University Hospital — Jena

Italy · 3 centers

• Universitaria delle Marche — Ancona
• ASST Azienda Ospedaliera Papa Giovanni XXIII — Bergamo
• ASST Niguarda Great Metropolitan Hospital — Milan

Poland · 3 centers

• Medical University of Białystok — Bialystok
• Medical University of Lodz — Lodz
• University Hospital Wroclaw — Wroclaw

Identifiers

NCT: NCT06898515 · IDE-G210258-CLN0002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗