Phase
Condition
Chest Pain
Heart Failure
Hyponatremia
Treatment
Reprieve System
furosemide infusion
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
Universitätsklinikum Gießen (UKGM)
Giessen 2920512, 35392
GermanyActive - Recruiting
Hannover University Hospital
Hanover 2910831, 30625
GermanyActive - Recruiting
University Hospital Heidelberg
Heidelberg 2907911,
GermanyActive - Recruiting
Jena University Hospital
Jena 2895044, 07747
GermanySite Not Available
Universitaria delle Marche
Ancona 3183089, 60121
ItalySite Not Available
ASST Azienda Ospedaliera Papa Giovanni XXIII
Bergamo 3182164, 24127
ItalySite Not Available
ASST Niguarda Great Metropolitan Hospital
Milan 6951411, 20162
ItalySite Not Available
Medical University of Białystok
Bialystok 776069, 15-089
PolandActive - Recruiting
Medical University of Lodz
Lodz 3093133, 70445
PolandActive - Recruiting
University Hospital Wroclaw
Wroclaw 3081368, 45573
PolandActive - Recruiting
Hospital de Bellvitge
Barcelona 3128760, 08907
SpainActive - Recruiting
Vall d'Hebron University Hospital
Barcelona 3128760, 08035
SpainActive - Recruiting
Hospital Ramon y Cajal
Madrid 3117735, 28000
SpainActive - Recruiting
Puerta de Hierro Majadahonda University Hospital
Madrid 3117735, 28222
SpainActive - Recruiting
Clínico Universitario de Valencia
Valencia 2509954, 46000
SpainActive - Recruiting
Hospital General Valencia
Valencia 2509954, 46000
SpainActive - Recruiting
University of California Irvine
Irvine, California 92697
United StatesSite Not Available
University of California Irvine
Irvine 5359777, California 5332921 92697
United StatesActive - Recruiting
Scripps Memorial Hospital
La Jolla 5363943, California 5332921 92037
United StatesSite Not Available
UC Davis Medical Center
Sacramento 5389489, California 5332921 95817
United StatesActive - Recruiting
University of Florida
Gainesville 4156404, Florida 4155751 32610
United StatesActive - Recruiting
Piedmont Atlanta Hospital
Atlanta 4180439, Georgia 4197000 30309
United StatesActive - Recruiting
Piedmont Augusta Hospital
Augusta 4180531, Georgia 4197000 30901
United StatesActive - Recruiting
Northeast Georgia Medical Center
Gainesville 4196586, Georgia 4197000 30501
United StatesActive - Recruiting
Advocate Christ Medical Center
Oak Lawn 4904365, Illinois 4896861 60453
United StatesSite Not Available
University of Kansas Medical Center
Kansas City 4273837, Kansas 4273857 66103
United StatesActive - Recruiting
University of Louisville Hospital
Louisville 4299276, Kentucky 6254925 40202
United StatesSite Not Available
Trinity Health Ann Arbor Hospital
Ann Arbor, Michigan 48197
United StatesSite Not Available
Trinity Health Ann Arbor Hospital
Ann Arbor 4984247, Michigan 5001836 48197
United StatesActive - Recruiting
Corewell Health Butterworth Hospital
Grand Rapids 4994358, Michigan 5001836 49503
United StatesActive - Recruiting
Corewell William Beaumont University Hospital
Royal Oak 5007804, Michigan 5001836 48073
United StatesActive - Recruiting
Minneapolis Heart Institute
Minneapolis 5037649, Minnesota 5037779 55407
United StatesActive - Recruiting
University of Mississippi
Jackson 4431410, Mississippi 4436296 38677
United StatesActive - Recruiting
St. Louis VA
St. Louis, Missouri 63130
United StatesActive - Recruiting
Washington University
St. Louis, Missouri 63130
United StatesSite Not Available
Harry S. Truman Veteran's Memorial Hospital
Columbia 4381982, Missouri 4398678 65201
United StatesSite Not Available
St. Louis VA
St Louis 4407066, Missouri 4398678 63130
United StatesActive - Recruiting
Washington University
St Louis 4407066, Missouri 4398678 63130
United StatesActive - Recruiting
University of Nebraska Medical Center
Omaha 5074472, Nebraska 5073708 68198
United StatesActive - Recruiting
Stony Brook University Hospital
Stony Brook 5139865, New York 5128638 11794
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 StatesSite Not Available
Duke University
Durham 4464368, North Carolina 4482348 27710
United StatesSite Not Available
Moses H. Cone Memorial Hospital
Greensboro 4469146, North Carolina 4482348 27401
United StatesSite Not Available
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem 4499612, North Carolina 4482348 27157
United StatesActive - Recruiting
Lindner Center at Christ Hospital
Cincinnati, Ohio 45219
United StatesSite Not Available
UH Cleveland Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
Ohio State University Hospital
Columbus, Ohio 43210
United StatesSite Not Available
Lindner Center at Christ Hospital
Cincinnati 4508722, Ohio 5165418 45219
United StatesActive - Recruiting
University of Cincinnati
Cincinnati 4508722, Ohio 5165418 45221
United StatesActive - Recruiting
UH Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 44106
United StatesActive - Recruiting
University Hospital Cleveland
Cleveland 5150529, Ohio 5165418 44106
United StatesActive - Recruiting
Ohio State University Hospital
Columbus 4509177, Ohio 5165418 43210
United StatesActive - Recruiting
Oklahoma Heart Hospital
Oklahoma City 4544349, Oklahoma 4544379 73120
United StatesActive - Recruiting
University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 191904
United StatesActive - Recruiting
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina 29605
United StatesSite Not Available
Prisma Health Greenville Memorial Hospital
Greenville 4580543, South Carolina 4597040 29605
United StatesActive - Recruiting
Baylor Scott and White
Dallas, Texas 75246
United StatesSite Not Available
Baylor Scott and White
Dallas 4684888, Texas 4736286 75246
United StatesActive - Recruiting
Baylor College of Medicine Ben Taub Hospital
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting
Memorial Hermann-Texas Medical Center
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting
Inova Fairfax Medical Campus
Falls Church 4758390, Virginia 6254928 22042
United StatesActive - Recruiting
VCU Medical Center
Richmond 4781708, Virginia 6254928 23219
United StatesActive - Recruiting
UW Harborview
Seattle 5809844, Washington 5815135 98104
United StatesActive - Recruiting
Aurora St. Luke's Medical Center
Milwaukee 5263045, Wisconsin 5279468 53215
United StatesSite Not Available

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