Endpoint | Time point after randomization | Remarks |
---|---|---|
Proportion of participants reaching a target BP of ≤130/80 mmHg in patients < 65 years of age and ≤ 140/90 mmHg in patients ≥ 65 years of age | At 4, 8, and 24 weeks | Same definition of target BP* as for the primary endpoint at 12 weeks |
Change in BP from enrolment | At 4, 8, 12, and 24 weeks | Reduction in mmHg |
Proportion of participants with treatment adaptations made to the primary treatment | By 12 weeks | Dose increase or decrease, and/or drug additions |
Proportion of participants with a blood pressure decrease of at least 20/10 mmHg | 4, 8, 12, and 24 weeks | |
Number of treatment adaptations per participant made to the primary treatment | By 12 weeks | Dose increase or decrease, and/or drug additions |
Time until target BP is (first) reached | Over 24 weeks | Censoring at last visit for those not observed to reach the target BP*, and for patients who achieve the target BP* any subsequent rebounds will be described but not included in this analysis |
Proportion of participants with changes in surrogate markers for hypertension-mediated organ damage (resolving, newly occurring or worsening) | Over 24 weeks | Surrogate markers of organ damage • Kidney impairment: decrease in eGFR (CKD-EPI formula); increase in proteinuria, measured by albumin/creatinine ratio or • Hypertensive heart disease: • Positive Sokolow-Lyon Index (Sokolow-Lyon voltage (SV1 + RV5/V6 ≥ 3.5 mV and/or RaVL ≥ 1.1 mV) on ECG [46, 47]) or • Signs of left ventricular hypertrophy [48] or left atrial remodeling/enlargement assessed by focused echocardiography [49, 50] or • Retinopathy: assessed by retinal picture [51]. |
Proportion of participants with major cardiovascular endpoints | Over 24 weeks | Major clinical endpoints of mortality, major cardiovascular events such as stroke, myocardial infarction, heart failure, end-stage kidney disease |
Proportion of participants lost to follow-up or stopped treatment | Over 24 weeks | |
Proportion of participants with at least one grade 3/4 adverse event | Over 24 weeks | Adverse events will be graded according to the CTCAE v5.0, January 2018 |
Proportion of participants with at least one severe adverse event | Over 24 weeks | |
Proportion of participants who were non-adherent to study drugs | Over 12 weeks | < 90% pill count or < 90% of self-reported drug intake |
Reasons for non-adherence assessed by pill count and self-report | Over 12 weeks | Descriptive analysis |