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REWORD-HF REverse WOrsening Renal Function in Decompensated Heart Failure

NCT01140399 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-04-10

No results posted yet for this study

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

Conditions

  • Acute Decompensated Heart Failure

Interventions

DRUG

Furosemide or Furosemide and Dopamine

Patients randomized to pharmacological treatment receive * either intravenous diuretics at escalating doses up to 20 mg/h * or intravenous diuretics up to 20 mg/h and dopamine infusion at a constant rate of 3 mcg/Kg/m.

DEVICE

Ultrafiltration

All loop diuretics will be discontinued. Rate of fluid removal will be based on the extent of fluid overload as assessed by increase in body weight vs the patient's known dry weight * less than 3 kg 200 ml/h * more than 3 kg and less than 5 kg 300 mlh * more than 5 kg 500 mlh Criteria for achievement of target UF goals are removal of \> 50% and \<70% of fluid excess based on the estimated increase in body weight Diuretic infusion is allowed provided that a minimum of 3 hours after the end of the UF session have elapsed, at a maximum cumulative dose of 100 mg furosemide, till start of the next UF session The use of inotropic agents is prohibited

Sponsors & Collaborators

  • Associazione Nazionale Medici Cardiologi Ospedalieri

    collaborator OTHER

  • Niguarda Hospital

    lead OTHER

Principal Investigators

  • Fabrizio Oliva, MD · Heart Failure Heart Transplant Program, Cardiovascular Department, Niguarda Hospital, Milan, Italy

  • Antonio Santoro, MD · Department of Nephrology, Dialysis and Hypertension, Sant'Orsola Malpighi Hospital, Bologna, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2011-06-30
Completion
2017-04-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01140399 on ClinicalTrials.gov