Cardiorenal Interactions During Treatment of Acute Decompensated Heart Failure: Diuretics Versus Ultrafiltration

Phase 3

Completed

• Conditions: Acute Decompensated Heart Failure
• Interventions: Procedure: ultrafiltration; Drug: diuretics

• Registration Number: NCT01138683
• Lead Sponsor: University Hospital, Ghent

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-06-04
• Study First Submitted QC: 2010-06-04
• Study First Posted: 2010-06-07
• Primary Completion: 2011-10
• Study Completion: 2011-12
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-09
• Last Update Posted: 2012-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ultrafiltration group	ultrafiltration	-
diuretics group	diuretics	-

Primary Outcome Measures

Name	Time	Method
Incidence of AKI and determining factors in patients with acute decompensated heart failure with treated with ultrafiltration versus diuretics	at 6 months

Secondary Outcome Measures

Name	Time	Method
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.	at 48h after treatment start
Combined endpoint of mortality/rehospitalisation-urgent outpatient visit due to heart failure	at 6 months
Kidney function measured by creatinine	after 28 days and 6 months

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium