Substudy\_ In a subset of patients, following informed consent, additional data collection will include annual NT-proBNP/BNP measurements, Echocardiogram baseline and annually and 14 Day ECG Continuous Monitoring at six month intervals.
Updated June 2024:
Additional analysis will be completed using the winratio analysis for the hierarchical primary outcome of:
1. All-cause mortality (time to event)
2. Heart Failure Events (number of events per year) defined as an admission to a healthcare facility for \> 24 hours or clinically significant worsening heart failure leading to an intervention (defined as treatment in an emergency department, a same-day access clinic, or an infusion centre) or unscheduled visits to a healthcare provider for administration of an intravenous diuretic as accepted by FDA, and an increase in chronic heart failure therapy
3. Minnesota Living with Heart Failure Questionnaire (change from baseline to 12-month)
4. Six Minute Hall Walk Test (change from baseline to 12-month)
