Fluid removal with the Reprieve System for acute decompensated heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 interventional trial compares device-guided decongestive therapy using the Reprieve System to optimal diuretic therapy (including IV furosemide) in adults admitted with acute decompensated heart failure. Eligible participants are adults expected to remain hospitalized >24 hours, on a chronic loop diuretic, at least 10 lb above dry weight, and meeting predefined markers of elevated diuretic resistance risk (low urine output after IV diuretic, low spot urine sodium, or hypochloremia). Participants receive either the Reprieve System intervention or standard care with diuretics and are monitored for measures of decongestion, urine output, safety, and clinical outcomes. The study is being conducted at several California medical centers and aims to determine whether the device provides more efficient fluid removal than current diuretic strategies.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of California Irvine
  Irvine, California, United States Recruiting
• Memorial Care Long Beach
  Long Beach, California, United States Recruiting
• UC Davis Medical Center
  Sacramento, California, United States Recruiting
• University of Florida
  Gainesville, Florida, United States Recruiting
• Piedmont Atlanta Hospital
  Atlanta, Georgia, United States Recruiting
• Wellstar Hospital
  Atlanta, Georgia, United States Recruiting

Study contacts

• Principal investigator: Javed Butler, MD, MPH, MBA — Baylor Scott and White Health
• Study coordinator: Annemarie Forrest
• Email: aforrest@reprievecardio.com
• Phone: 617-848-0400

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.