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Withdrawal of drug therapy in responders to cardiac resynchronization therapy: rationale and design of the REMOVE trial.
- Source :
-
Revista espanola de cardiologia (English ed.) [Rev Esp Cardiol (Engl Ed)] 2024 Oct; Vol. 77 (10), pp. 851-858. Date of Electronic Publication: 2024 May 01. - Publication Year :
- 2024
-
Abstract
- Introduction and Objectives: Cardiac resynchronization therapy (CRT) is an effective treatment for patients with nonischemic dilated cardiomyopathy associated with left bundle branch block (LBBB). In these patients, the device can normalize left ventricular ejection fraction (LVEF). Nevertheless, it remains unclear whether CRT responders still require neurohormonal blockers. The aim of this study is to determine the long-term safety of withdrawing drug therapy in these patients.<br />Methods: The REMOVE trial is a prospective, multicenter, open-label and randomized 1:1 study designed to assess the effect of withdrawing neurohormonal blockers in patients with nonischemic dilated cardiomyopathy associated with left bundle branch block who recovered LVEF after CRT. The study will include a 12-month follow-up with the option to continue into the follow-up extension phase for up to 24 months. The primary endpoint is the recurrence of cardiomyopathy defined as any of the following criteria: a) a reduction in LVEF >10% (provided the LVEF is <50%); b) a reduction in LVEF >10% accompanied by an increase >15% in the indexed end-systolic volume relative to the previous value and in a range higher than the normal values, or c) decompensated heart failure requiring intravenous diuretic administration. In patients meeting the primary endpoint, drug therapy will be restarted.<br />Conclusions: The results of this study will help to enhance our understanding of CRT superresponders, a specific group of patients. Registred at ClinicalTrials.gov (Identifier: NCT05151861).<br /> (Copyright © 2024 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)
- Subjects :
- Humans
Prospective Studies
Female
Male
Ventricular Function, Left physiology
Treatment Outcome
Withholding Treatment
Aged
Follow-Up Studies
Middle Aged
Heart Failure therapy
Heart Failure physiopathology
Cardiac Resynchronization Therapy methods
Stroke Volume physiology
Bundle-Branch Block therapy
Bundle-Branch Block physiopathology
Bundle-Branch Block diagnosis
Cardiomyopathy, Dilated therapy
Cardiomyopathy, Dilated complications
Cardiomyopathy, Dilated physiopathology
Subjects
Details
- Language :
- English; Spanish; Castilian
- ISSN :
- 1885-5857
- Volume :
- 77
- Issue :
- 10
- Database :
- MEDLINE
- Journal :
- Revista espanola de cardiologia (English ed.)
- Publication Type :
- Academic Journal
- Accession number :
- 38701881
- Full Text :
- https://doi.org/10.1016/j.rec.2024.02.021