Back to results

Semaglutide for people with obesity and resistant hypertension trial (SUPPORT): a pilot randomised, double blind, parallel group, integrated, multicentre clinical trial.

Hypertension is the leading risk factor for morbidity and mortality globally, yet its management remains inadequate. Resistant hypertension (RH) refers to patients with uncontrolled blood pressure (BP) on at least three anti-hypertensive agents, including a diuretic. Patients with RH are more likely to have obesity and cardiovascular disease. Treatment of RH is problematic and necessitates new approaches. The Semaglutide Treatment Effect for People with obesity trials (STEP) provide evidence of the positive effect of semaglutide, a glucagon like peptide-1 receptor agonist (GLP-1 RA), on body weight and BP.
The research question is whether a weight-centric approach, with semaglutide, for patients with obesity and RH, but without diabetes, results in a clinically meaningful reduction in BP versus standard care. A pilot randomized, double blind, parallel group, multicentre trial will be performed to inform an international, multicentre definitive trial.
The study aims to recruit 64 participants. Recruitment includes eligible patients from primary and secondary care beginning with a pre-screening process using patient records. Participants are invited to attend a screening visit which includes initial consent and training. They enter a four week placebo run-in period to assess adherence. Participants are consented, randomized 1:1 and allocated with concealment to treatment groups using minimization by baseline BP. All clinical staff and participants are blinded.
Follow-up is every 12 weeks with a final visit repeating baseline measures at 36 weeks. Participant follow-up appointments occur remotely or with their practitioner according to participant choice. If follow-up is remote, patients are asked to measure their weight and BP at home. Patients are asked to report events of concern and these are verified with healthcare providers by the study team.
The primary outcome is the change in BP. Other outcomes include body weight, change to anti-hypertensive medications, drug tolerability and safety, and patient reported outcomes. For the feasibility study, outcomes include BP variability, recruitment yield, recruitment rate and acceptability of trial processes to participants. A SWAT also examines the feasibility of patient choice in a clinical trial. Participant focus groups gather feedback regarding choice of in-person versus remote follow-up and how this affected participants interaction with the trial.