Majert J, Nazarzadeh M, Ramakrishnan R, Bidel Z, Hedgecott D, Perez-Crespillo A, Turpie W, Akhtar N, Allison M, Rao S, Gudgin B, McAuley M, A'Court C, Billot L, Kotecha D, Potter J, and Rahimi K
Background: Older patients with multimorbidity and polypharmacy have been under-represented in clinical trials. We aimed to assess the effect of different intensities of antihypertensive treatment on changes in blood pressure, major safety outcomes, and patient-reported outcomes in this population., Methods: ATEMPT was a decentralised, two-armed, parallel-group, open-label randomised controlled pilot trial conducted in the Thames Valley area, South East England. Individuals aged 65 years or older with multimorbidity (three or more chronic conditions) or polypharmacy (five or more types of medications) and a systolic blood pressure of 115-165 mm Hg were eligible for inclusion. Participants were identified through a search of national hospital discharge databases, identification of patients registered with an online pharmacy, and via targeted advertising on social media platforms. Participants were randomly assigned to receive up to two more classes versus up to two fewer classes of antihypertensive medications. Apart from routine home visits for conducting the baseline assessment, all communication, monitoring, and management of participants by the trial team was conducted remotely. The primary outcome was change in home-measured blood pressure., Findings: Between Dec 15, 2020, and Aug 31, 2022, 230 participants were randomly assigned (n=126 to more vs n=104 to fewer antihypertensive medications). The frequency of serious adverse events was similar across both groups; no cardiovascular events occurred in the more antihypertensive drugs group, compared with six in the fewer antihypertensive drugs group, of which two were fatal. Over a 13-month follow-up period, the mean systolic blood pressure in the group allocated to receive more antihypertensive medications decreased from 134·5 mm Hg (SD 10·7) at baseline to 122·1 mm Hg (10·5). By contrast, in the group allocated to receive fewer antihypertensive medications, it remained relatively unchanged, moving from 134·8 mm Hg (SD 11·2) at baseline to 132·9 mm Hg (15·3); this corresponded to a mean difference of -10·7 mm Hg (95% CI -17·5 to -4·0)., Interpretation: Remotely delivered antihypertensive treatment substantially reduced systolic blood pressure in older adults who are often less represented in trials, with no increase in the risk of serious adverse events. The results of this trial will inform a larger clinical trial focusing on assessing major cardiovascular events, safety, physical functioning, and cognitive function that is currently in the planning stages. These results also underscore the efficiency of decentralised trial designs, which might be of broader interest in other settings., Funding: National Institute for Health Research Oxford Biomedical Research Centre and the Oxford Martin School., Competing Interests: Declaration of interests KR reports grants outside the submitted work from the British Heart Foundation, Horizon Europe AI4HF consortium (R79992/CN001), Novo Nordisk Oxford Big Data Partnership, University of Oxford, and UK Research and Innovation's Global Challenge Research Fund (grant reference: ES/P011055/1). KR has previously received consulting fees from Medtronic CRDN, and honoraria or fees from BMJ Heart, PLoS Medicine, AstraZeneca MEA Region, Medscape, and WebMD Medscape UK. MN is supported by a research fellowship from the British Heart Foundation (grant number FS/IPBSRF/22/27060). JP is supported by the British Heart Foundation, outside of the submitted work. DK receives grants from the National Institute for Health and Care Research (NIHR), British Heart Foundation, EU/EFPIA Innovative Medicines Initiative, UK National Health Service, Cook & Wolstenholme Charitable Trust, European Society of Cardiology, Bayer, Amomed, and Protherics Medicines Development, all outside the submitted work. BG and MMA received patient and public involvement payments in line with NIHR guidelines for public contributors. AP-C reports consulting fees from Leantropy. All other authors declare no competing interests., (Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)