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RECRUITINGPhase 3INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form 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 Who Should NOT Join This Trial: 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). ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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

Locations (20)

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