Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial.

摘要: Summary Background An increasing number of patients with heart failure receive implantable cardioverter-defibrillators (ICDs) or cardiac resynchronisation defibrillators (CRT-Ds) telemonitoring function. Early detection worsening failure, upstream factors predisposing to by implant-based might enable pre-emptive intervention and improve outcomes, but the evidence is weak. We investigated this possibility in IN-TIME, a clinical trial. Methods did randomised, controlled trial at 36 tertiary centres hospitals Australia, Europe, Israel. enrolled chronic NYHA class II–III symptoms, ejection fraction no more than 35%, optimal drug treatment, permanent atrial fibrillation, recent dual-chamber ICD CRT-D implantation. After 1 month run-in phase, were randomly assigned (1:1) either automatic, daily, implant-based, multiparameter addition standard care without telemonitoring. Investigators not masked treatment allocation. Patients allocation unless they contacted because findings. Follow-up was year. The primary outcome measure composite score combining all-cause death, overnight hospital admission for change class, patient global self-assessment, intention-to-treat population. registered ClinicalTrials.gov, NCT00538356. Findings 716 patients, whom 664 (333 telemonitoring, 331 control). Mean age 65·5 years mean 26%. 285 (43%) had functional II 378 (57%) III. Most received CRT-Ds (390; 58·7%). At year, 63 (18·9%) 333 group versus 90 (27·2%) control (p=0·013) worsened (odds ratio 0·63, 95% CI 0·43–0·90). Ten 27 died during follow-up. Interpretation Automatic, can significantly outcomes failure. Such feasible should be used practice. Funding Biotronik SE & Co. KG.