Overview

REWORD-HF REverse WOrsening Renal Function in Decompensated Heart Failure

Status:
Terminated
Trial end date:
2017-04-01
Target enrollment:
0
Participant gender:
All
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 is limited by further worsening renal function, fluid removal by ultrafiltration is superior to different pharmacological approaches in acutely relieving congestion and preventing further deterioration in renal function and whether it results in longer admission-free survival 90 days after enrolment
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Niguarda Hospital
Collaborator:
Associazione Nazionale Medici Cardiologi Ospedalieri
Treatments:
Diuretics
Dopamine
Dopamine Agents
Furosemide
Criteria
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