Hypertension is a risk factor for cardiovascular disease (CVD) and a major cause of morbidity and mortality worldwide. However, uncertainty exists between different european guidelines on the treatment of patients who fall into the category of elevated blood pressure (BP 120-139/70-89mmHg). Around 50% of the adult general population falls under this category, making it extremely important to identify those who have sufficiently high risk to deserve BP-lowering treatment. At the same time, overtreatment poses a valid safety concern, and the risk-benefit ratio must be clearly assessed. Therefore, there is a clear unmet need and evaluating the effectiveness and feasibility of this risk-based approach is essential for its implementation in clinical practice. ELEVATE will evaluate the effectiveness in terms of reducing vascular organ damage (arterial stiffness) and CVD events of a risk-based treatment strategy for individuals with elevated BP compared to standard care. This will be a randomised, parallel, open-label, pragmatic, investigator-initiated, interventional clinical trial that will include patients with elevated BP along with the presence of a high risk condition. Additionally, the trial will evaluate office and home BP, drug-related serious adverse effects, patient-reported outcomes such as quality of life, adherence and treatment satisfaction, cost effectiveness. Long-term effectiveness and safety outcomes will be collected through access to national electronic medical registries of mortality and hospitalisations and general practitioner (GP) registries. Notably, the trial will engage key stakeholders, including GPs, pharmacists, patients, and industrial partners. Furthermore, in the long term, the study is projected to generate a European network for clinical trials in hypertension management, through collaboration between hypertension specialists and GPs, for the development of evidence-based guidelines.
