Table 4.

Study end points

Primary efficacy end point	Composite of the number of unplanned HF-related rehospitalizations or all-cause mortality 365 days after randomization (12-month time)
Primary safety end point	1. Device/system-related complications (DSRC) of the patients as a result of the attempted or successful implantation of an CardioMEMS™ sensor at the 12-month time point and 2. Freedom from sensor failures at the 12-month time
Secondary end points	(A) Health-related quality of life  Major secondary: changes in quality of life (QoL) measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) scores (TSS, OSS, CSS), after 6 and 12 months  Changes in QoL scores measured after 6 and 12 months using Euro-QoL-5D (B) Mortality  HF-related mortality in the 12-month period  Other cardiovascular mortality in the 12-month period  Non-cardiovascular mortality in the 12-month period  All-cause mortality in the 12-month period (C) Unplanned hospitalizations  HF-related hospitalizations in the 12-month period  Other cardiac-related hospitalizations in the 12-month period  Non-cardiovascular-related hospitalizations in the 12-month period  All-cause hospitalizations in the 12-month period  Number of days alive and out of hospital in the 12-month period (D) Adverse events  Frequency of adverse events in the 12-month period  Frequency of serious adverse events in the 12-month period (E) Symptoms of heart failure and psychometric assessments  Patient-reported symptoms of heart failure assessed by the KCCQ Symptoms Score  Unscheduled HF-related hospitalizations  HF-related mortality  Days alive and out of hospital  Laboratory parameters for organ damage and disease progression  Change in symptom burden of anxiety (GAD-7) at 6- and 12-month time points  Change in symptom burden of depressive symptoms (PHQ-9) at 6- and 12-month time points (F) Care-related aspects  Patient adherence in the intervention group in terms of obtaining PA pressure readings, at 6 and 12 months  Change in PA pressure values at 6 and 12 months, based on the area under the curve  Number of adjustments made within each guideline-recommended substance class and their underlying reasons  Change in drug dose (equivalent dosages) of maximum guideline-recommended substance class received, at 6 and 12 months  Rate of documented atrial and ventricular arrhythmias over a 12-month period  Laboratory measures of organ damage and disease progression: renal and cardiac biomarkers with associated changes  Health economic data (resource use) at 6- and 12-month time points