REWORD-HF REverse WOrsening Renal Function in Decompensated Heart Failure

NCT01140399 | Terminated Phase 4 DMC

• 2 other identifiers: EudraCT code 2009-014FO001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 16

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 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

Keywords

1 Acute Decompensated Heart Failure; 2 Cardiorenal Syndrome; 3 Ultrafiltration; 4 Dopamine

Outcome Measures

Primary Outcomes (1)

• Changes in a composite clinical-lab score

  Changes in a score derived by summing up changes in dyspnea, weight loss, glomerular filtration rate (GFR), brain natriuretic peptide (BNP)

  Baseline and 96 h after randomization,precisely:48 h after end of the last UF session in the intervention arm;24 h after end of 72 h infusional drug treatment in the control arm

Secondary Outcomes (11)

• Changes in the dyspnea Likert scale

  Measured at day 4, at day 10, at day 90 vs baseline

• Changes in modified RIFLE (AKIN) stage

  Measured at day 4 vs baseline

• Length of stay during index admission

  Measured at average day 10

• Occurrence of major adverse events

  Measured at day 90

• Days spent alive and out of hospital (DAOH) within 90 days

  Measured at day 90

Study Arms (2)

Infusional drug treatment

ACTIVE COMPARATOR

Diuretics or diuretics plus fixed low dose dopamine infusion

Drug: Furosemide or Furosemide and Dopamine

Ultrafiltration

EXPERIMENTAL

Device: Ultrafiltration appliance Sessions of 8 h UF are conducted on 2 subsequent days in the first 48 hours after randomization; a third session is performed on day 3 in case of persistent congestion

Device: Ultrafiltration

Interventions

Furosemide or Furosemide and Dopamine DRUG

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.

Infusional drug treatment

Ultrafiltration DEVICE

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

Ultrafiltration

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Niguarda Hospital: lead
• Associazione Nazionale Medici Cardiologi Ospedalieri: collaborator

Study Sites (16)

Fondazione S. Maugeri. IRCCS Istituto di Cassano Murge

Cassano Murge, Bari, Italy

Location

Ospedale Civile di Legnano Cardiology

Legnano, Milano, 20025, Italy

Location

Istituto Clinico Humanitas - IRCCS Clinical Cardiology Cardiovascular Department

Rozzano, Milano, 20089, Italy

Location

Azienda Ospedaliera S. Gerardo Heart Failure and Cardiomyopathy Clinic

Monza, Monza Brianza, 20052, Italy

Location

Gruppo Policlinico di Monza Clinical Cardiology and Heart Failure Unit - Cardiology Department

Monza, Monza Brianza, 20052, Italy

Location

Ospedali Riuniti di Ancona Cardiology Presidio Lancisi

Ancona, 60020, Italy

Location

Ospedali Riuniti di Bergamo - Cardiovascular Medicine

Bergamo, 24128, Italy

Location

Azienda Ospedaliero-Universitaria di Bologna, Policlinico S.Orsola-Malpighi - Cardiology Unit

Bologna, 40138, Italy

Location

Azienda Ospedaliero-Universitaria di Bologna, Policlinico S.Orsola-Malpighi - Nefrology,Dialysis and Hypertension Unit

Bologna, 40138, Italy

Location

Azienda Ospedaliera Sant'Anna - Cardiology

Como, 22100, Italy

Location

Ospedale SS Annunziata Cardiology

Cosenza, 87100, Italy

Location

Azienda Istituti Ospitalieri di Cremona Cardiology

Cremona, 26100, Italy

Location

Centro Cardiologico Monzino, I.R.C.C.S. Cardiology Intensive Care

Milan, 20138, Italy

Location

Azienda Ospedaliera Niguarda - Heart Failure and Heart Transplant Program

Milan, 20162, Italy

Location

Ospedale Guglielmo da Saliceto Cardiology Department

Piacenza, 29100, Italy

Location

AO Verona Ospedale Civile Maggiore Cardiology Unit

Verona, 37126, Italy

Location

Related Publications (1)

• Srivastava M, Harrison N, Caetano AFS, Tan AR, Law M. Ultrafiltration for acute heart failure. Cochrane Database Syst Rev. 2022 Jan 21;1(1):CD013593. doi: 10.1002/14651858.CD013593.pub2.

  PMID: 35061249 DERIVED

MeSH Terms

Interventions

Furosemide; Dopamine; Ultrafiltration

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Extracorporeal Circulation; Surgical Procedures, Operative; Filtration; Chemistry Techniques, Analytical; Investigative Techniques; Physical Phenomena; Chemical Phenomena

Study Officials

• Fabrizio Oliva, MD

  Heart Failure Heart Transplant Program, Cardiovascular Department, Niguarda Hospital, Milan, Italy

  STUDY CHAIR

• Antonio Santoro, MD

  Department of Nephrology, Dialysis and Hypertension, Sant'Orsola Malpighi Hospital, Bologna, Italy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2010
• First Posted: June 9, 2010
• Study Start: February 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: April 1, 2017
• Last Updated: April 10, 2017

Record last verified: 2017-04

Locations

IT (16)