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

Launched by REPRIEVE CARDIOVASCULAR, INC · Mar 25, 2025

Keywords

ClinConnect Summary

The FASTR-II clinical trial is studying a new treatment approach for patients with acute decompensated heart failure (ADHF), a serious condition where the heart can't pump blood effectively, leading to fluid buildup in the body. The trial is comparing a device called the Reprieve System, which aims to help remove excess fluid more efficiently, to the standard treatment known as Optimal Diuretic Therapy (ODT). This study hopes to find out if using the Reprieve System can help patients feel better and recover faster.

To be eligible for the trial, participants must be at least 22 years old, have been diagnosed with heart failure, and have certain symptoms and test results indicating they need treatment. They should also be experiencing weight gain due to fluid retention and currently taking a specific medication called a loop diuretic. However, individuals with certain medical issues, such as severe lung disease, recent heart attacks, or other serious health conditions, may not be able to participate. If someone joins the trial, they can expect to receive either the new Reprieve System treatment or the standard therapy during their hospital stay, and their progress will be closely monitored by healthcare professionals.

Gender

ALL

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.