PRecision Event Monitoring for PatienTs with Heart Failure using HeartLogic (PREEMPT‐HF) study design and enrolment

Autor: John Boehmer, Andrew J. Sauer, Roy Gardner, Craig M. Stolen, Brian Kwan, Ramesh Wariar, Stephen Ruble
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: ESC Heart Failure, Vol 10, Iss 6, Pp 3690-3699 (2023)
Druh dokumentu: article
ISSN: 2055-5822
DOI: 10.1002/ehf2.14469
Popis: Abstract Aims The HeartLogic multisensor index has been found to be a sensitive predictor of worsening heart failure (HF). However, there is limited data on this index's association and its constituent sensors with HF readmissions. Methods and results The PREEMPT‐HF study is a global, multicentre, prospective, observational, single‐arm, post‐market study. HF patients with an implantable defibrillator device or cardiac resynchronization therapy with defibrillator with HeartLogic capabilities were eligible if sensor data collection was turned on and the HeartLogic feature was not enabled. Thus, the HeartLogic Index/alert and heart sounds sensor trends were unavailable via the LATITUDE remote monitoring system to clinicians (blinded). Evaluation of subject medical records at 6 months and a final in‐clinic visit at 12 months was required for collection of all‐cause hospitalizations and HF outpatient visits. The purpose of this study is exploratory, no formal hypothesis tests are planned, and no adjustment for multiple testing will be performed. A total of 2183 patients were enrolled at 103 sites between June 2018 and June 2020. A significant proportion of the patients were implanted with implantable defibrillator devices (39%) versus cardiac resynchronization therapy with defibrillator (61%); were female (27%); over 65 (61%); New York Heart Association class I (13%), II (53%), and III (33%); ejection fraction
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