Phase
Condition
Chest Pain
Heart Failure
Congestive Heart Failure
Treatment
furosemide infusion
Reprieve System
Clinical Study ID
Ages > 22 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosis of HF with expected hospitalization >24 hours, with >1 new or worseningsymptom and >2 physical examination, laboratory, or invasive findings of HF, andreceiving 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 withstudy 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 IVloop diuretic >= 40 mg furosemide equivalent
Exclusion
Exclusion Criteria:
Urologic issues that would predispose the participant to a high rate of urogenitaltrauma or infection with catheter placement or known inability to place a Foleycatheter.
Hemodynamic instability as defined by any of the following: sustained systolic bloodpressure <90 mmHg for >15 minutes within the past 48 hours, use of IV vasopressorsor inotropes within past 48 hours, and/or current or previous mechanical circulatorysupport within the last week.
Uncontrolled arrhythmias defined as sustained HR >130 beats/min for >10 minuteswithin the past 48 hours.
Severe lung disease with chronic home oxygen requirement >2L/min.
Acute infection with evidence of systemic involvement (e.g., clinically suspectedinfection with fever or elevated serum white blood cell count).
Estimated glomerular filtration rate (eGFR) <25 ml/min/1.73m2 (calculated witheither MDRD or CKD-EPI) or current use of renal replacement therapy (RRT).
Significant left ventricular outflow obstruction, severe uncorrected complexcongenital heart disease, known severe stenotic valvular disease, severeinfiltrative or constrictive cardiomyopathy or other diagnosis that would makeaggressive decongestion unsafe.
Current or recent (< 30 days) type I myocardial infarction (e.g., acute coronarysyndrome such as NSTEMI or STEMI from plaque rupture), coronary artery bypasssurgery, or stroke. An isolated troponin elevation (e.g., from volume overload ordemand ischemia) is not a reason for exclusion.
Severe electrolyte abnormalities (e.g., serum potassium <3.0 mEq/L, magnesium <1.3mEq/L or sodium <125 mEq/L). Note: These are based on baseline/screening labs.Participants whose electrolyte levels are repleted cannot be reassessed forinclusion in the trial.
Other concomitant disease or condition the investigator believes will make itdifficult to follow instructions or comply with study procedures and/or follow-upvisits, including expected prolonged hospitalization for reasons other thandecongestive therapy
Currently enrolled in an interventional trial (observational studies are permitted).
Life expectancy less than 6 months.
Women who are pregnant or breastfeeding.
Study Design
Connect with a study center
University of California Irvine
Irvine, California 92697
United StatesSite Not Available
Trinity Health Ann Arbor Hospital
Ann Arbor, Michigan 48197
United StatesActive - Recruiting
St. Louis VA
St. Louis, Missouri 63130
United StatesActive - Recruiting
Washington University
St. Louis, Missouri 63130
United StatesActive - Recruiting
Duke University
Durham, North Carolina 27710
United StatesSite Not Available
Moses H. Cone Memorial Hospital
Greensboro, North Carolina 27401
United StatesSite Not Available
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina 27157
United StatesActive - Recruiting
Lindner Center at Christ Hospital
Cincinnati, Ohio 45219
United StatesSite Not Available
Ohio State University Hospital
Columbus, Ohio 43210
United StatesSite Not Available
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina 29605
United StatesActive - Recruiting
Baylor Scott and White
Dallas, Texas 75246
United StatesSite Not Available
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