Arterial Hypertension
Conditions
Brief summary
Time until first occurrence of, - non-fatal stroke,, - non-fatal myocardial infarction,, - revascularisation procedures for atherosclerotic disease,, - hospitalisation or emergency department for HF,, - unplanned hospitalisation for new-onset atrial fibrillation (AF), new-onset atrial flutter (AFL) or ventricular arrhythmia,, - sustained decline in the eGFR of at least 50% (estimated by CKD-EPICr 2021 formula), - end-stage kidney disease o defined as eGFR <15 mL/min/1.73m2 or requiring chronic dialysis or renal transplantation,, - death from renal or CV causes
Detailed description
Individual components of the primary composite outcome, All-cause mortality, Rate of the decline in the eGFR, estimated by CKD-EPICr 2021 formula at 8 weeks and 48 months, Change in systolic BP at 8 weeks, 12 months and 48 months, Change in diastolic BP at 8 weeks, 12 months and 48 months, Composite of primary endpoint or death from any cause, Development of type 2 diabetes,, Time to coronary revascularization procedure, Improvement in quality of life (respective area-under-the-curve (AUC) of EQ VAS Score and HeartQoL Global Score changes. (Assessment Points: Baseline, 12 months, 24, and 48 months)., Decline of cognition (MoCA Test Score, Assessment Points: Baseline, 12 months, 24, and 48 months), Increase of blood markers of neurodegeneration (Ptau 217, Nfl) (Assessment Points: Baseline, 12 months, 24, and 48 months), Frailty (Assessment Points: Baseline, 12 months, 24, and 48 months)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time until first occurrence of, - non-fatal stroke,, - non-fatal myocardial infarction,, - revascularisation procedures for atherosclerotic disease,, - hospitalisation or emergency department for HF,, - unplanned hospitalisation for new-onset atrial fibrillation (AF), new-onset atrial flutter (AFL) or ventricular arrhythmia,, - sustained decline in the eGFR of at least 50% (estimated by CKD-EPICr 2021 formula), - end-stage kidney disease o defined as eGFR <15 mL/min/1.73m2 or requiring chronic dialysis or renal transplantation,, - death from renal or CV causes | — |
Secondary
| Measure | Time frame |
|---|---|
| Individual components of the primary composite outcome, All-cause mortality, Rate of the decline in the eGFR, estimated by CKD-EPICr 2021 formula at 8 weeks and 48 months, Change in systolic BP at 8 weeks, 12 months and 48 months, Change in diastolic BP at 8 weeks, 12 months and 48 months, Composite of primary endpoint or death from any cause, Development of type 2 diabetes,, Time to coronary revascularization procedure, Improvement in quality of life (respective area-under-the-curve (AUC) of EQ VAS Score and HeartQoL Global Score changes. (Assessment Points: Baseline, 12 months, 24, and 48 months)., Decline of cognition (MoCA Test Score, Assessment Points: Baseline, 12 months, 24, and 48 months), Increase of blood markers of neurodegeneration (Ptau 217, Nfl) (Assessment Points: Baseline, 12 months, 24, and 48 months), Frailty (Assessment Points: Baseline, 12 months, 24, and 48 months) | — |
Countries
Germany