Personalised approach to hypertension treatment: Rationale and design of the HYPERMARKER randomised trial
Abstract
ABSTRACT:
Background and Objective: Blood pressure treatment response is variable in individual patients, and the choice of medical therapy is often dependent on clinician experience. Treatment choices can be personalised by patient empowerment, metabolomic profiles and augmented by machine learning, but robust evaluation is lacking on how these can be combined to enhance clinical effectiveness. The HYPERMARKER trial will evaluate how an individualised choice of medication class can address the avoidable global health and economic burdens of hypertension.
Design and Intervention: The HYPERMARKER trial is a proof-of-concept, pragmatic, multicentre, adaptive, open-label strategy trial embedded into routine clinical practice with stratified individual patient randomisation. The trial was co-designed with a patient and public involvement team. The intervention is a digital portal that supports shared decision making on hypertension therapy class using clinical features plus metabolomic profiles determined with liquid chromatography-mass spectrometry.
Participants and Outcomes: Eligible patients are aged ≥18yrs with a systolic blood pressure ≥140mmHg and a clinical indication for antihypertensive therapy. 400 participants will be randomised to usual standard of care for treatment selection, or to the intervention group. Remote follow-up will occur through a patient smartphone application and linked blood pressure monitor to assess the primary outcome of change in home systolic…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 400 participants or records.
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