The study design was discussed with the institutional patient advisory group and representatives from patient organisations and was presented at the National Heart Failure Patient Health Care Professional Research Forum, receiving positive feedback. The trial was authorised by the Medicines and Healthcare Products Regulatory Agency and annual development safety update reports were provided. The trial was approved by the National Research Ethics Committee (16/LO/0065), to whom annual progress reports were submitted, and given NHS Permission by the Royal Brompton and Harefield NHS Trust after review of study documentation and discussion of the risks and benefits. The possible risk of heart failure and major arrhythmia was discussed. All patients provided written informed consent. Patients were identified at the trial centre and participant identification centres in the UK (Guy's and St Thomas' NHS Foundation Trust, King's College Hospital NHS Foundation Trust, St George's NHS Foundation Trust, London Northwest NHS Healthcare Trust, Epsom and St Helier University Hospitals, and Basildon and Thurrock University Hospitals). Investigations were done at a single centre (Royal Brompton and Harefield NHS Foundation Trust, London, UK). We did an open-label, pilot, randomised trial of phased withdrawal of pharmacological treatment for heart failure. This trial is registered with, number NCT02859311. The primary analysis was by intention to treat. The primary endpoint was a relapse of dilated cardiomyopathy within 6 months, defined by a reduction in LVEF of more than 10% and to less than 50%, an increase in LVEDV by more than 10% and to higher than the normal range, a two-fold rise in NT-pro-BNP concentration and to more than 400 ng/L, or clinical evidence of heart failure, at which point treatments were re-established. After 6 months, patients in the continued treatment group had treatment withdrawn by the same method. Patients were recruited from a network of hospitals in the UK, assessed at one centre (Royal Brompton and Harefield NHS Foundation Trust, London, UK), and randomly assigned (1:1) to phased withdrawal or continuation of treatment. We did an open-label, pilot, randomised trial to examine the effect of phased withdrawal of heart failure medications in patients with previous dilated cardiomyopathy who were now asymptomatic, whose left ventricular ejection fraction (LVEF) had improved from less than 40% to 50% or greater, whose left ventricular end-diastolic volume (LVEDV) had normalised, and who had an N-terminal pro-B-type natriuretic peptide (NT-pro-BNP) concentration less than 250 ng/L. The Lancet Regional Health – Western Pacific.The Lancet Regional Health – Southeast Asia.The Lancet Gastroenterology & Hepatology.
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