Expert group sets out principles for device-led hypertension trials

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A consensus document outlining design principles and outcome definitions for device-based therapies for hypertension has been published in the journal Circulation.

The development of the document has been led by the Hypertension Academic Research Consortium (HARC), which aims to create consensus among experts involved in developing device-based therapies for hypertension, following the process defined in the Academic Research Consortium (ARC). Its drafting brought together clinicians, trialists, regulators, and industry.

According to HARC, despite its recognition worldwide as the leading cause of death and disability, awareness, treatment and control of blood pressure have plateaued, if not “moderately declined”. Recent large randomised clinical trials have demonstrated clinical benefits of more intensive blood pressure reduction, the authors note, which has led to revision of guideline directed treatment goals to further lower systolic and diastolic blood pressure standards.

“Countering evidence-based efforts to improve blood pressure with a broad spectrum of pharmaceutical therapies are routine challenges in clinical practice that include patient intolerance of medication-related adverse effects, general non-adherence with prescribed therapy, and physician inertia for treatment of an illness that remains largely silent until onset of clinically irreversible conditions,” authors of the consensus paper write.

“The advancement of device-based approaches to hypertension has been motivated by clinical implications associated with a persistently high prevalence of both uncontrolled blood pressure and medication non-adherence. The expansion of device technologies and emerging clinical trials imparts the need for consistency in trial design, conduct and definitions of clinical study elements to allow for trial comparability and data poolability,” the authors add.

“The HARC programme represented an integration of evolving evidence and consensus opinion among leading experts in cardiovascular medicine and hypertension research with regulatory perspective on clinical trial design and methodology. From this programme, clinical trial design and principles and outcomes definitions for studies aimed at evaluating device-based hypertension therapies were established, and standardisation of blood pressure assessment, effectiveness measures beyond blood pressure, and safety outcomes have been proposed,” they add.


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