Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)
Recruiting · NCT06898515 · Interventional (participants receive a specific treatment) · Lead sponsor: Reprieve Cardiovascular, Inc
View the official record on ClinicalTrials.gov →Interventions studied
Reprieve Systemfurosemide infusion
What this trial is about
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.
Who can take part
Age range
22 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
53 locations listed across 21 US states.
- University of California Irvine - Irvine, California, United States
- Scripps Memorial Hospital - La Jolla, California, United States
- UC Davis Medical Center - Sacramento, California, United States
- University of Florida - Gainesville, Florida, United States
- Piedmont Atlanta Hospital - Atlanta, Georgia, United States
- Piedmont Augusta Hospital - Augusta, Georgia, United States
- Northeast Georgia Medical Center - Gainesville, Georgia, United States
- Advocate Christ Medical Center - Oak Lawn, Illinois, United States
- University of Kansas Medical Center - Kansas City, Kansas, United States
- University of Louisville Hospital - Louisville, Kentucky, United States
- Trinity Health Ann Arbor Hospital - Ann Arbor, Michigan, United States
- Corewell Health Butterworth Hospital - Grand Rapids, Michigan, United States
- Corewell William Beaumont University Hospital - Royal Oak, Michigan, United States
- Minneapolis Heart Institute - Minneapolis, Minnesota, United States
- University of Mississippi - Jackson, Mississippi, United States
- Harry S. Truman Veteran's Memorial Hospital - Columbia, Missouri, United States
- St. Louis VA - St Louis, Missouri, United States
- Washington University - St Louis, Missouri, United States
- University of Nebraska Medical Center - Omaha, Nebraska, United States
- Stony Brook University Hospital - Stony Brook, New York, United States
- Duke University - Durham, North Carolina, United States
- Moses H. Cone Memorial Hospital - Greensboro, North Carolina, United States
- Atrium Health Wake Forest Baptist Medical Center - Winston-Salem, North Carolina, United States
- Lindner Center at Christ Hospital - Cincinnati, Ohio, United States
- University of Cincinnati - Cincinnati, Ohio, United States
- UH Cleveland Medical Center - Cleveland, Ohio, United States
- Ohio State University Hospital - Columbus, Ohio, United States
- Oklahoma Heart Hospital - Oklahoma City, Oklahoma, United States
- University of Pennsylvania - Philadelphia, Pennsylvania, United States
- Prisma Health Greenville Memorial Hospital - Greenville, South Carolina, United States
- Baylor Scott and White - Dallas, Texas, United States
- Baylor College of Medicine Ben Taub Hospital - Houston, Texas, United States
- Memorial Hermann-Texas Medical Center - Houston, Texas, United States
- Inova Fairfax Medical Campus - Falls Church, Virginia, United States
- VCU Medical Center - Richmond, Virginia, United States
- UW Harborview - Seattle, Washington, United States
- Aurora St. Luke's Medical Center - Milwaukee, Wisconsin, United States
- Universitaria delle Marche - Ancona, Italy
- Vall d'Hebron University Hospital - Barcelona, Spain
- Hospital de Bellvitge - Barcelona, Spain
- ASST Azienda Ospedaliera Papa Giovanni XXIII - Bergamo, Italy
- Medical University of Białystok - Bialystok, Poland
- Universitätsklinikum Gießen (UKGM) - Giessen, Germany
- Hannover University Hospital - Hanover, Germany
- University Hospital Heidelberg - Heidelberg, Germany
- Jena University Hospital - Jena, Germany
- Medical University of Lodz - Lodz, Poland
- Hospital Ramon y Cajal - Madrid, Spain
- Puerta de Hierro Majadahonda University Hospital - Madrid, Spain
- ASST Niguarda Great Metropolitan Hospital - Milan, Italy
- Clínico Universitario de Valencia - Valencia, Spain
- Hospital General Valencia - Valencia, Spain
- University Hospital Wroclaw - Wroclaw, Poland