Status:
TERMINATED
REWORD-HF REverse WOrsening Renal Function in Decompensated Heart Failure
Lead Sponsor:
Niguarda Hospital
Collaborating Sponsors:
Associazione Nazionale Medici Cardiologi Ospedalieri
Conditions:
Acute Decompensated Heart Failure
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether in patients with acute decompensated congestive heart failure and the cardiorenal syndrome, i.e. a state in which therapy directed to improve symptoms...
Detailed Description
Acute decompensated congestive heart failure (ADCHF), the most common single cause of hospitalization over 65 years, results in 4-8% in-hospital mortality and 30-38% incidence of readmissions within 3...
Eligibility Criteria
Inclusion
- Inclusion criteria
- On admission (screening)
- Informed consent
- 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 test)
- 24 hours after admission (randomization)
- Persistent 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
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01140399
Start Date
February 1 2011
End Date
April 1 2017
Last Update
April 10 2017
Active Locations (16)
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1
Fondazione S. Maugeri. IRCCS Istituto di Cassano Murge
Cassano Murge, Bari, Italy
2
Ospedale Civile di Legnano Cardiology
Legnano, Milano, Italy, 20025
3
Istituto Clinico Humanitas - IRCCS Clinical Cardiology Cardiovascular Department
Rozzano, Milano, Italy, 20089
4
Azienda Ospedaliera S. Gerardo Heart Failure and Cardiomyopathy Clinic
Monza, Monza Brianza, Italy, 20052