Trial design
WATCHFUL
RECRUITMENT
The WATCHFUL trial is a 6-month multicenter, parallel-group, randomized, controlled, superiority trial with a 6-month follow-up. The trial protocol has been approved by the Ethics Committee of the General University Hospital, Prague (20/16 Grant VES 2017 AZV VFN), and the trial has been registered in ClinicalTrials.gov (identifier: NCT03041610, registered: 3/2/2017, The trial recruited patients with HFrEF from six cardiovascular centers, five of them in academic hospitals throughout the Czech Republic. Patient recruitment started in August 2018 and was completed in December 2022; thus, the 6-month intervention is anticipated to finish in June 2023, and the 6-month follow-up in December 2023. Compared to the timelines reported in the published trial protocol, both the start and end of the trial were delayed: the start was delayed by 16 months due to a lack of funding, and the end was delayed by additional 20 months due to the COVID-19 pandemic that slowed down the recruitment. The primary analysis will be performed after the intervention phase at six months. No interim analyses have been planned before the end of the intervention phase.