REWORD-HF REverse WOrsening Renal function in Decompensated Heart Failure Impact of different therapeutic approaches in patients with cardiorenal syndrome in the setting of acute decompensated congestive heart failure (ADCHF) - REWORD-HF

• Conditions: acute decompensated congestive heart failure; MedDRA version: 9.1Level: LLTClassification code 10064652

• Registration Number: EUCTR2009-014769-16-IT
• Lead Sponsor: AZIENDA OSPEDALIERA OSPEDALE NIGUARDA CA` GRANDA (A.O. DI RILIEVO NAZIONALE)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-02
• Last Update Posted: 14 October 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Informed consent On admission - Age 18-80 years - NYHA class III IV - Signs of pulmonary (pulmonary rales, and interstitial oedema or pleural effusion on chest Xray) and/or systemic congestion (pitting ankle oedema and enlarged liver or ascites and neck vein distension ≥ 7 cm) and weight gain ≥ 2 kg during the previous week - Glomerular filtration rate ≥ 30 ml/min - BNP increased >400 pg/ml (diagnostic cut-off for ADCHF), as confirmatory diagnostic test28 24 hours after admission (randomization) - Persistents signs of pulmonary (pulmonary rales, interstitial oedema or pleural effusion on chest Xray) and/or systemic congestion (ankle oedema, enlarged liver or ascites, neck vein distension ≥ 7 cm) - Serum creatinine or urine output criteria indicative of modified RIFLE (AKI: risk) class at least 1 (increase x 1.5 in serum creatinine or decrease > 25% in GFR or urine output < 0.5 ml/Kg/h for more than 6 hours) 29-30 during diuretic infusion
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Chronic kidney disease stage 4-5 (GFR < 30 ml/min) - Acute coronary syndromes - Systolic blood pressure <90 mm Hg/need for intravenous inotropes - Hematocrit > 45% - Unattainable venous access - Contraindications to anticoagulation by heparin - Systemic infection - Heart transplant

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified