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

Lead sponsor

Reprieve Cardiovascular, Inc is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Study arms

• Experimental
  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.

  Device: Reprieve System

• Active comparator
  Optimal Diuretic Therapy (ODT)

  Participants randomized to ODT will be treated with guided diuretic titration, as recommended in the ESC guidelines on diuretic therapy

  Drug: furosemide infusion

• No intervention
  Registry

  Participants will be treated per local site usual care.

Interventions

• DeviceReprieve 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.

• Drugfurosemide infusion

  Participants randomized to ODT will be treated with guided diuretic titration, as recommended in the ESC guidelines on diuretic therapy

Primary outcomes

1. Hierarchical composite/win-ratio

   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

   Time frame: 1. up to 30 days from randomization, 2. up to 30 days from discharge, 3. up to 72 hours after randomization

2. Incidence of device/procedure-related adverse events (KDIGO stage 2 or greater AKI, CAUTI)

   KDIGO stage 2 or greater AKI: ≥ doubling of serum creatinine or use of renal replacement therapy; CAUTI per CDC definition

   Time frame: initiation of randomized therapy through 72 hours following completion of randomized therapy

Secondary outcomes

1. Net sodium loss

   Time frame: per 24 hours at end of randomized therapy

2. Time to discharge readiness

   Time from initiation of randomized therapy to when the participant becomes medically ready for discharge from a decompensated heart failure treatment standpoint

   Time frame: through hospital discharge, an average of 5 days

3. Time on IV diuretic therapy

   Time frame: randomization through hospital discharge, assessed up to 30 days

4. Net fluid loss

   Fluid input subtracted from total urine output

   Time frame: per 24 hours at end of randomized therapy

5. Weight loss

   Time frame: per 24 hours at end of randomized therapy

6. CV mortality and cumulative HF rehospitalizations

   Both types of events will be combined in a total "event rate" compared between groups

   Time frame: 90 days after hospital discharge

7. Length of stay

   Time from initiation of randomized therapy to hospital discharge

   Time frame: through hospital discharge, an average of 5 days

8. 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

9. Severe electrolyte abnormality

   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

   Time frame: initiation of randomized therapy up to 72 hours after stopping randomized therapy

10. Worsening heart failure requiring a higher level of HF therapy

    Time frame: initiation of randomized therapy up to 72 hours after stopping randomized therapy

11. Tinnitus or hearing loss lasting more than 30 minutes

    Time frame: initiation of randomized therapy up to 12 hours after stopping randomized therapy

Individual participant data

Plan to share: No