Priscila Raupp da Rosa1, Luis E Rohde1, Madeni Doebber1, Antonio L P Ribeiro2, Deborah P Prado2, Eduardo G Bertoldi3, Jose A Figueiredo Neto4, Ilmar Kohler5, Luis Beck-da-Silva6, Luiz C Danzmann7, Lidia Zytynski Moura8, Marciane Rover9, Marcus V Simões10, Roberto T Sant'Anna9, Andréia Biolo11. 1. Hospital de Clínicas de Porto Alegre e Faculdade de Medicina da Universidade Federal do Rio Grande do Sul, Porto Alegre, (RS), Brazil; Hospital Moinhos de Vento, Porto Alegre, (RS), Brazil. 2. Hospital das Clinicas e Faculdade de Medicina da Universidade Federal de Minas Gerais, Belo Horizonte, (MG), Brazil. 3. Hospital Escola da Universidade Federal de Pelotas, Pelotas, (RS), Brazil. 4. Hospital Universitário da Universidade Federal do Maranhão, São Luis, (MA), Brazil. 5. Hospital Universitário da Universidade Luterana do Brasil, Canoas, (RS), Brazil. 6. Hospital Moinhos de Vento, Porto Alegre, (RS), Brazil. 7. Hospital Universitário da Universidade Luterana do Brasil, Canoas, (RS), Brazil; Hospital São Lucas da Pontifícia Universidade Católica, Porto Alegre, (RS), Brazil. 8. Hospital Universitário Cajuru da Pontifícia Universidade Católica, Curitiba, (PR), Brazil. 9. Instituto de Cardiologia, Fundação Universitária de Cardiologia, Porto Alegre, (RS), Brazil. 10. Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo, Ribeirão Preto, (SP), Brazil. 11. Hospital de Clínicas de Porto Alegre e Faculdade de Medicina da Universidade Federal do Rio Grande do Sul, Porto Alegre, (RS), Brazil.
Abstract
AIMS: Furosemide is commonly prescribed for symptom relief in heart failure (HF) patients. Although few data support the continuous use of loop diuretics in apparently euvolemic HF patients with mild symptoms, there is concern about safety of diuretic withdrawal in these patients. The ReBIC-1 trial was designed to evaluate the safety and tolerability of withdrawing furosemide in stable, euvolemic, chronic HF outpatients. This multicenter initiative is part of the Brazilian Research Network in Heart Failure (ReBIC) created to develop clinical studies in HF and composed predominantly by university tertiary care hospitals. METHODS: The ReBIC-1 trial is currently enrolling HF patients in NYHA functional class I-II, left ventricular ejection fraction ≤45%, without a HF-related hospital admission within the last 6 months, receiving a stable dose of furosemide (40 or 80 mg per day) for at least 6 months. Eligible patients will be randomized to maintain or withdraw furosemide in a double-blinded protocol. The trial has two co-primary outcomes: (1) dyspnea assessment using a visual-analogue scale evaluated at 4 time points and (2) the proportion of patients maintained without diuretics during the follow-up period. Total sample size was calculated to be 220 patients. Enrolled patients will be followed up to 90 days after randomization, and diuretic will be restarted if clinical deterioration or signs of congestion are detected. Pre-defined sub-group analysis based on NT-proBNP levels at baseline is planned. PERSPECTIVE: Evidence-based strategies aiming to simplify HF pharmacotherapy are needed in clinical practice. The ReBIC-1 trial will determine the safety of withdrawing furosemide in stable chronic HF patients.
RCT Entities:
AIMS: Furosemide is commonly prescribed for symptom relief in heart failure (HF) patients. Although few data support the continuous use of loop diuretics in apparently euvolemic HF patients with mild symptoms, there is concern about safety of diuretic withdrawal in these patients. The ReBIC-1 trial was designed to evaluate the safety and tolerability of withdrawing furosemide in stable, euvolemic, chronic HF outpatients. This multicenter initiative is part of the Brazilian Research Network in Heart Failure (ReBIC) created to develop clinical studies in HF and composed predominantly by university tertiary care hospitals. METHODS: The ReBIC-1 trial is currently enrolling HF patients in NYHA functional class I-II, left ventricular ejection fraction ≤45%, without a HF-related hospital admission within the last 6 months, receiving a stable dose of furosemide (40 or 80 mg per day) for at least 6 months. Eligible patients will be randomized to maintain or withdraw furosemide in a double-blinded protocol. The trial has two co-primary outcomes: (1) dyspnea assessment using a visual-analogue scale evaluated at 4 time points and (2) the proportion of patients maintained without diuretics during the follow-up period. Total sample size was calculated to be 220 patients. Enrolled patients will be followed up to 90 days after randomization, and diuretic will be restarted if clinical deterioration or signs of congestion are detected. Pre-defined sub-group analysis based on NT-proBNP levels at baseline is planned. PERSPECTIVE: Evidence-based strategies aiming to simplify HF pharmacotherapy are needed in clinical practice. The ReBIC-1 trial will determine the safety of withdrawing furosemide in stable chronic HF patients.
Authors: Jennifer Cautela; Jean-Michel Tartiere; Alain Cohen-Solal; Anne Bellemain-Appaix; Alexis Theron; Thierry Tibi; James L Januzzi; François Roubille; Nicolas Girerd Journal: Eur J Heart Fail Date: 2020-04-30 Impact factor: 15.534