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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

Page last updated: August 23, 2015

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