Cardio‐Sis 2014.

Methods	Prospective, multicentre, randomized study with 2 parallel groups, ITT strategy, open‐label design. Follow‐up: 2 years
Participants	Adults aged > 55 years with uncontrolled SBP (≥ 150 mmHg) and ≥ 1 additional cardiovascular risk factor (cigarette smoking, total cholesterol ≥ 5.2 mmol/L, HDL‐C < 1.0 mmol/L, LDL‐C ≥ 3.4 mmol/L, family history of premature CVD in a first‐degree relative (aged < 65 years in women and < 55 years in men), previous TIA or stroke, or established coronary or peripheral arterial disease). Exclusion criteria: diabetes, kidney failure, chronic atrial fibrillation or flutter, clinically significant hepatic or haematological disorders, alcoholism, or drug addiction, with causes precluding ECG interpretation for LVH, significant valvular heart disease, or any disease causing reduced life expectancy. Baseline characteristics (% or mean): men/women: 52%/48%; age: 71 (SD 7) years; SBP: 159 (SD 9) mmHg; DBP: 85 (SD 9) mmHg; current smoker: 7%; ethnic group: white: 100%. Country: Italy
Interventions	Standard (conventional) target: SBP < 140 mmHg Lower (aggressive) target: SBP < 130 mmHg
Outcomes	Primary outcome: prevalence of ECG LV hypertrophy at the final 2‐year visit. Main secondary outcome: composite of all‐cause mortality, non‐fatal MI, non‐fatal stroke, TIA, CHF NYHA stage III or IV requiring hospitalization, angina pectoris with objective evidence of myocardial ischaemia, new‐onset atrial fibrillation, coronary revascularization, aortic dissection, occlusive peripheral arterial disease, and kidney failure requiring dialysis. For participants with > 1 event, survival time up to the first event was used in the analysis. The comparison between groups in serial changes in SBP and DBP was another secondary endpoint of the study.
Notes	216 participants (115 in standard group, 101 in lower group) met the inclusion criteria for the review, but additional information on outcomes is needed to obtain useful data. Study authors were contacted, and they forwarded our questions to the Steering Committee. An answer had not been received from the committee before review publication. Blood pressures achieved at the end of the trial were: standard target: SBP 139 (SD 14) mmHg; lower target: SBP 134 (SD 14) mmHg.