TY - JOUR AB - BackgroundPatients with dilated cardiomyopathy whose symptoms and cardiac function have recovered often ask whether their medications can be stopped. The safety of withdrawing treatment in this situation is unknown.MethodsWe 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. 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. After 6 months, patients in the continued treatment group had treatment withdrawn by the same method. 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. The primary analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT02859311.FindingsBetween April 21, 2016, and Aug 22, 2017, 51 patients were enrolled. 25 were randomly assigned to the treatment withdrawal group and 26 to continue treatment. Over the first 6 months, 11 (44%) patients randomly assigned to treatment withdrawal met the primary endpoint of relapse compared with none of those assigned to continue treatment (Kaplan-Meier estimate of event rate 45·7% [95% CI 28·5–67·2]; p=0·0001). After 6 months, 25 (96%) of 2 AU - Halliday,BP AU - Wassall,R AU - Lota,A AU - Khalique,Z AU - Gregson,J AU - Newsome,S AU - Jackson,R AU - Rahneva,T AU - Wage,R AU - Smith,G AU - Venneri,L AU - Tayal,U AU - Auger,D AU - Midwinter,W AU - Whiffin,N AU - Rajani,R AU - Dungu,J AU - Cook,S AU - Ware,J AU - Baksi,J AU - Pennell,D AU - Rosen,S AU - Cowie,M AU - Cleland,J AU - Prasad,S DO - 10.1016/S0140-6736(18)32484-X EP - 73 PY - 2019/// SN - 0140-6736 SP - 61 TI - Withdrawal of pharmacological treatment for heart failure in patients with recovered dilated cardiomyopathy (TRED-HF): an open-label, pilot, randomised trial T2 - The Lancet UR - http://dx.doi.org/10.1016/S0140-6736(18)32484-X UR - https://www.sciencedirect.com/science/article/pii/S014067361832484X?via%3Dihub UR - http://hdl.handle.net/10044/1/65228 VL - 393 ER -