Cardiorenal Interactions During Treatment of Acute Decompensated Heart Failure: Diuretics Versus Ultrafiltration
Information source: University Hospital, Ghent
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Decompensated Heart Failure
Intervention: ultrafiltration (Procedure); diuretics (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: University Hospital, Ghent Official(s) and/or principal investigator(s): Sofie Gevaert, MD, Principal Investigator, Affiliation: University Hospital Ghent, Belgium
Summary
The CRUF trial is a prospective randomized monocentric trial comparing different impact of
diuretics versus ultrafiltration on renal congestion, plasma refill rate, echocardiographic
filling pressures, neurohormonal activation and biomarkers of Acute Kidney Injury (AKI).
Clinical Details
Official title: Cardiorenal Interactions During Treatment of Acute Decompensated Heart Failure: Diuretics Versus Ultrafiltration
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Incidence of AKI and determining factors in patients with acute decompensated heart failure with treated with ultrafiltration versus diuretics
Secondary outcome: determination of the value of Neutrophil gelatinase-associated lipocalin (NGAL) to predict AKI in acute decompensated heart failure (vs creatinine, Cystatin C,measured urinary creatinine clearance) in patients treated with diuretics vs ultrafiltration.Combined endpoint of mortality/rehospitalisation-urgent outpatient visit due to heart failure Kidney function measured by creatinine
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- >18 years old
- Severe systolic heart failure with ejection fraction <40%
- And Hospitalisation for decompensated heart failure
- And New York Heart Association (NYHA) III or IV
- And 1 of the following:
- Jugular vein distension>6cm
- Tissue Doppler mitral annulus lateral>12 or medial>15
- Chest X-ray: pulmonary edema or pleural effusion
Exclusion Criteria:
- Need for inotropic or vasopressive agents
- Use of intravenous (IV) contrast media
- Acute coronary syndrome
- Need of dialysis
- Severe co-morbidity
- Contra-indications for anticoagulation
- Pregnancy
Locations and Contacts
University Hospital Ghent, Ghent, Belgium
Additional Information
website of University Hospital Ghent
Starting date: February 2010
Last updated: January 9, 2012
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