REWORD-HF REverse WOrsening Renal Function in Decompensated Heart Failure
- Conditions
- Acute Decompensated Heart Failure
- Interventions
- Device: Ultrafiltration
- Registration Number
- NCT01140399
- Lead Sponsor
- Niguarda Hospital
- 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
- 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 months after discharge. While fluid accumulation remains the main factor causing hospitalization, impaired cardiac output in ADHF causes renal arterial underfilling and increased venous pressure, reducing the glomerular filtration rate and causing acute kidney injury.
Aggressive therapy is required to alleviate volume overload during hospital admission and achievement of a dry weight is capital in preventing rehospitalisation. Currently diuretics are considered the standard of care for volume overload in ADHF, yet any patients, especially those with advanced HF become soon resistant to standard doses of loop diuretics, so escalating doses and the association of thiazides are often required to achieve effective diuresis, an approach that will progressively worsen renal function, causing the cardiorenal syndrome.
When diuretic resistance develops and symptoms persists, mechanical fluid removal via ultrafiltration should be considered. Ultrafiltration is an alternative method of sodium and water removal, that filters plasma water directly across a semipermeable membrane in response to a transmembrane pressure gradient, resulting in an ultrafiltrate that is isoosmotic compared with plasma water, In view of the limits of traditional therapies for the treatment of congestion and concomitant progressive renal dysfunction in ADHF patients, there is a compelling need for additional studies to individuate the better method for fluid removal in volume-overloaded patients and guide management decisions to reduce associated morbidity.
The main objectives of the present project are to evaluate whether in patients with acute decompensated congestive heart failure and the cardiorenal syndrome, i.e. a state in which therapy directed to improve CHF 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Infusional drug treatment Furosemide or Furosemide and Dopamine Diuretics or diuretics plus fixed low dose dopamine infusion Ultrafiltration Ultrafiltration 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
- Primary Outcome Measures
Name Time Method Changes in a composite clinical-lab score 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 Changes in a score derived by summing up changes in dyspnea, weight loss, glomerular filtration rate (GFR), brain natriuretic peptide (BNP)
- Secondary Outcome Measures
Name Time Method 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 All cause mortality, hospital readmission and unscheduled office and emergency department visits for ADCHF
Days spent alive and out of hospital (DAOH) within 90 days Measured at day 90 Sum of days spent alive and out of hospital
BNP changes Measured at day 0, at day 4, at 10 and day 90 Changes in BNP at specified times VS baseline
Changes in neutrophil gelatinase associated lipocalin (NGAL) Measured at day -1, at day 0 and day 4 Changes in NGAL at specified times VS screening
Changes in Cystatin C (CysC) Measured at day 0, day 4, day 10 and day 90 Changes in Cystatin C (CysC) at specified times VS baseline
Treatment-related adverse events Measured at day 4 Bleeding, thrombosis, clotting, infection
Adverse changes in blood pressure, heart rate and rhythm Measured at day 4 Hypotension (\< 90 mmHg), tachycardia (\> 110 bpm) arrhythmias
Adverse changes in lab parameters Measured at day 4 Hyper-Azotemia (\>180 mg/dl), hyper-kaliemia (6.5 mEq/l), hemoconcentration (hematocrit \>45%)
Trial Locations
- Locations (16)
Fondazione S. Maugeri. IRCCS Istituto di Cassano Murge
๐ฎ๐นCassano Murge, Bari, Italy
Ospedale SS Annunziata Cardiology
๐ฎ๐นCosenza, Italy
Ospedale Civile di Legnano Cardiology
๐ฎ๐นLegnano, Milano, Italy
Istituto Clinico Humanitas - IRCCS Clinical Cardiology Cardiovascular Department
๐ฎ๐นRozzano, Milano, Italy
Gruppo Policlinico di Monza Clinical Cardiology and Heart Failure Unit - Cardiology Department
๐ฎ๐นMonza, Monza Brianza, Italy
Azienda Ospedaliera S. Gerardo Heart Failure and Cardiomyopathy Clinic
๐ฎ๐นMonza, Monza Brianza, Italy
Ospedali Riuniti di Ancona Cardiology Presidio Lancisi
๐ฎ๐นAncona, Italy
Azienda Istituti Ospitalieri di Cremona Cardiology
๐ฎ๐นCremona, Italy
Azienda Ospedaliero-Universitaria di Bologna, Policlinico S.Orsola-Malpighi - Cardiology Unit
๐ฎ๐นBologna, Italy
Azienda Ospedaliero-Universitaria di Bologna, Policlinico S.Orsola-Malpighi - Nefrology,Dialysis and Hypertension Unit
๐ฎ๐นBologna, Italy
Azienda Ospedaliera Sant'Anna - Cardiology
๐ฎ๐นComo, Italy
Ospedali Riuniti di Bergamo - Cardiovascular Medicine
๐ฎ๐นBergamo, Italy
Azienda Ospedaliera Niguarda - Heart Failure and Heart Transplant Program
๐ฎ๐นMilano, Italy
AO Verona Ospedale Civile Maggiore Cardiology Unit
๐ฎ๐นVerona, Italy
Centro Cardiologico Monzino, I.R.C.C.S. Cardiology Intensive Care
๐ฎ๐นMilano, Italy
Ospedale Guglielmo da Saliceto Cardiology Department
๐ฎ๐นPiacenza, Italy