Rational and design of a randomized, double-blind, multicenter trial to evaluate the safety and tolerability of furosemide withdrawal in stable chronic outpatients with heart failure: The ReBIC-1 trial.

Autor: da Rosa PR; 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., Rohde LE; 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., Doebber M; 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., Ribeiro ALP; Hospital das Clinicas e Faculdade de Medicina da Universidade Federal de Minas Gerais, Belo Horizonte, (MG), Brazil., Prado DP; Hospital das Clinicas e Faculdade de Medicina da Universidade Federal de Minas Gerais, Belo Horizonte, (MG), Brazil., Bertoldi EG; Hospital Escola da Universidade Federal de Pelotas, Pelotas, (RS), Brazil., Figueiredo Neto JA; Hospital Universitário da Universidade Federal do Maranhão, São Luis, (MA), Brazil., Kohler I; Hospital Universitário da Universidade Luterana do Brasil, Canoas, (RS), Brazil., Beck-da-Silva L; Hospital Moinhos de Vento, Porto Alegre, (RS), Brazil., Danzmann LC; Hospital Universitário da Universidade Luterana do Brasil, Canoas, (RS), Brazil; Hospital São Lucas da Pontifícia Universidade Católica, Porto Alegre, (RS), Brazil., Moura LZ; Hospital Universitário Cajuru da Pontifícia Universidade Católica, Curitiba, (PR), Brazil., Rover M; Instituto de Cardiologia, Fundação Universitária de Cardiologia, Porto Alegre, (RS), Brazil., Simões MV; Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo, Ribeirão Preto, (SP), Brazil., Sant'Anna RT; Instituto de Cardiologia, Fundação Universitária de Cardiologia, Porto Alegre, (RS), Brazil., Biolo A; Hospital de Clínicas de Porto Alegre e Faculdade de Medicina da Universidade Federal do Rio Grande do Sul, Porto Alegre, (RS), Brazil.
Jazyk: angličtina
Zdroj: American heart journal [Am Heart J] 2017 Dec; Vol. 194, pp. 125-131. Date of Electronic Publication: 2017 Aug 24.
DOI: 10.1016/j.ahj.2017.08.012
Abstrakt: 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.
(Copyright © 2017 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
Externí odkaz: