| Methods | Prospective multicentre, randomized study with two parallel groups, ITT strategy, open‐label design. The follow‐up was 2 years |
| Participants | Adults aged over 55 years with uncontrolled SBP (≥ 150 mmHg) and at least one additional cardiovascular risk factor (cigarette smoking, total cholesterol ≥ 5.2 mmol/L, HDL cholesterol < 1.0 mmol/L, LDL cholesterol ≥ 3.4 mmol/L, family history of premature CVD in a first degree relative (< 65 years in women and < 55 years in men), previous TIA or stroke, or established coronary or peripheral arterial disease). Exclusion criteria included diabetes, kidney failure, chronic atrial fibrillation or flutter, clinically significant hepatic or haematological disorders, alcoholism, drug addiction, causes precluding ECG interpretation for LVH, significant valvular heart disease or any disease causing reduced life expectancy. Baseline characteristics for participants potentially included in the review (in percentages (%) or mean ± SD): men/women (52/48%); age (71 ± 7 years); SBP (159 ± 9 mmHg); DBP (85 ± 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 | The primary study outcome was the prevalence of electrocardiographic LV (left ventricular) hypertrophy at the final two year visit. The main prespecified secondary outcome was a composite of all‐cause mortality, non fatal MI, non fatal stroke, TIA, CHF NYHA stages III‐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 more than one event, the survival time up to the first event was used in the analysis. The comparison between the groups in the serial changes in SBP and DBP was another secondary end point of the study |
| Notes | 216 participants (115 standard, 101 lower) met the inclusion criteria for the review but additional information on outcomes is needed to obtain useful data. The 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 ± 14 mmHg; lower target: SBP 134 ± 14 mmHg |
Abbreviations: ACEI ‐ angiotensin converting enzyme inhibitors; CABG ‐ coronary artery bypass graft; CHF ‐ coronary heart failure; CCB ‐ calcium channel blockers; CVA ‐ cerebrovascular accident; CVD ‐ cardiovascular disease; DBP ‐ diastolic blood pressure; ECG ‐ electrocardiogram; HDL ‐ high density lipoprotein; IHD ‐ ischaemic heart disease; ITT ‐ intention‐to‐treat; LDL ‐ low density lipoprotein; LVH ‐ left ventricular hypertrophy; MI ‐ myocardial infarction; NIDDM ‐ non insulin dependent diabetes mellitus; SBP ‐ systolic blood pressure; SD ‐ standard deviation.