Personalized Antihypertensive Treatment Optimization With Smartphone‐Enabled Remote Precision Dosing of Amlodipine During the COVID‐19 Pandemic (PERSONAL‐CovidBP Trial)
Background The objective of the PERSONAL‐CovidBP (Personalised Electronic Record Supported Optimisation When Alone for Patients With Hypertension: Pilot Study for Remote Medical Management of Hypertension During the COVID‐19 Pandemic) trial was to assess the efficacy and safety of smartphone‐enabled...
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Language: | English |
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Wiley
2024-02-01
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Series: | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
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Online Access: | https://www.ahajournals.org/doi/10.1161/JAHA.123.030749 |
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author | David J. Collier Mike Taylor Thomas Godec Julian Shiel Rebecca James Yasmin Chowdury Patrizia Ebano Vivienne Monk Mital Patel Jane Pheby Ruby Pheby Amanda Foubister Clovel David Manish Saxena Leanne Richardson James Siddle Gregor Timlin Paul Goldsmith Nicholas Deeming Neil R. Poulter Rhian Gabe Richard J. McManus Mark J. Caulfield |
author_facet | David J. Collier Mike Taylor Thomas Godec Julian Shiel Rebecca James Yasmin Chowdury Patrizia Ebano Vivienne Monk Mital Patel Jane Pheby Ruby Pheby Amanda Foubister Clovel David Manish Saxena Leanne Richardson James Siddle Gregor Timlin Paul Goldsmith Nicholas Deeming Neil R. Poulter Rhian Gabe Richard J. McManus Mark J. Caulfield |
author_sort | David J. Collier |
collection | DOAJ |
description | Background The objective of the PERSONAL‐CovidBP (Personalised Electronic Record Supported Optimisation When Alone for Patients With Hypertension: Pilot Study for Remote Medical Management of Hypertension During the COVID‐19 Pandemic) trial was to assess the efficacy and safety of smartphone‐enabled remote precision dosing of amlodipine to control blood pressure (BP) in participants with primary hypertension during the COVID‐19 pandemic. Methods and Results This was an open‐label, remote, dose titration trial using daily home self‐monitoring of BP, drug dose, and side effects with linked smartphone app and telemonitoring. Participants aged ≥18 years with uncontrolled hypertension (5–7 day baseline mean ≥135 mm Hg systolic BP or ≥85 mm Hg diastolic BP) received personalized amlodipine dose titration using novel (1, 2, 3, 4, 6, 7, 8, 9 mg) and standard (5 and 10 mg) doses daily over 14 weeks. The primary outcome of the trial was mean change in systolic BP from baseline to end of treatment. A total of 205 participants were enrolled and mean BP fell from 142/87 (systolic BP/diastolic BP) to 131/81 mm Hg (a reduction of 11 (95% CI, 10–12)/7 (95% CI, 6–7) mm Hg, P<0.001). The majority of participants achieved BP control on novel doses (84%); of those participants, 35% were controlled by 1 mg daily. The majority (88%) controlled on novel doses had no peripheral edema. Adherence to BP recording and reported adherence to medication was 84% and 94%, respectively. Patient retention was 96% (196/205). Treatment was well tolerated with no withdrawals from adverse events. Conclusions Personalized dose titration with amlodipine was safe, well tolerated, and efficacious in treating primary hypertension. The majority of participants achieved BP control on novel doses, and with personalization of dose there were no trial discontinuations due to drug intolerance. App‐assisted remote clinician dose titration may better balance BP control and adverse effects and help optimize long‐term care. Registration URL: clinicaltrials.gov. Identifier: NCT04559074. |
first_indexed | 2024-03-07T23:33:03Z |
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institution | Directory Open Access Journal |
issn | 2047-9980 |
language | English |
last_indexed | 2025-02-18T07:48:44Z |
publishDate | 2024-02-01 |
publisher | Wiley |
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series | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
spelling | doaj.art-edf98ae531c74f1fb009f04bf415e6552024-11-05T14:15:41ZengWileyJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease2047-99802024-02-0113410.1161/JAHA.123.030749Personalized Antihypertensive Treatment Optimization With Smartphone‐Enabled Remote Precision Dosing of Amlodipine During the COVID‐19 Pandemic (PERSONAL‐CovidBP Trial)David J. Collier0Mike Taylor1Thomas Godec2Julian Shiel3Rebecca James4Yasmin Chowdury5Patrizia Ebano6Vivienne Monk7Mital Patel8Jane Pheby9Ruby Pheby10Amanda Foubister11Clovel David12Manish Saxena13Leanne Richardson14James Siddle15Gregor Timlin16Paul Goldsmith17Nicholas Deeming18Neil R. Poulter19Rhian Gabe20Richard J. McManus21Mark J. Caulfield22William Harvey Research Institute Queen Mary University of London London UKClosed Loop Medicine London UKWilliam Harvey Research Institute Queen Mary University of London London UKWilliam Harvey Research Institute Queen Mary University of London London UKWilliam Harvey Research Institute Queen Mary University of London London UKWilliam Harvey Research Institute Queen Mary University of London London UKWilliam Harvey Research Institute Queen Mary University of London London UKWilliam Harvey Research Institute Queen Mary University of London London UKWilliam Harvey Research Institute Queen Mary University of London London UKWilliam Harvey Research Institute Queen Mary University of London London UKWilliam Harvey Research Institute Queen Mary University of London London UKWilliam Harvey Research Institute Queen Mary University of London London UKWilliam Harvey Research Institute Queen Mary University of London London UKWilliam Harvey Research Institute Queen Mary University of London London UKClosed Loop Medicine London UKClosed Loop Medicine London UKClosed Loop Medicine London UKClosed Loop Medicine London UKTrialsConnect London UKImperial College Clinical Trials Unit, School of Public Health, Imperial College London London UKWolfson Institute of Population Health Queen Mary University of London London UKNuffield Department of Primary Care Health Sciences University of Oxford Oxford UKWilliam Harvey Research Institute Queen Mary University of London London UKBackground The objective of the PERSONAL‐CovidBP (Personalised Electronic Record Supported Optimisation When Alone for Patients With Hypertension: Pilot Study for Remote Medical Management of Hypertension During the COVID‐19 Pandemic) trial was to assess the efficacy and safety of smartphone‐enabled remote precision dosing of amlodipine to control blood pressure (BP) in participants with primary hypertension during the COVID‐19 pandemic. Methods and Results This was an open‐label, remote, dose titration trial using daily home self‐monitoring of BP, drug dose, and side effects with linked smartphone app and telemonitoring. Participants aged ≥18 years with uncontrolled hypertension (5–7 day baseline mean ≥135 mm Hg systolic BP or ≥85 mm Hg diastolic BP) received personalized amlodipine dose titration using novel (1, 2, 3, 4, 6, 7, 8, 9 mg) and standard (5 and 10 mg) doses daily over 14 weeks. The primary outcome of the trial was mean change in systolic BP from baseline to end of treatment. A total of 205 participants were enrolled and mean BP fell from 142/87 (systolic BP/diastolic BP) to 131/81 mm Hg (a reduction of 11 (95% CI, 10–12)/7 (95% CI, 6–7) mm Hg, P<0.001). The majority of participants achieved BP control on novel doses (84%); of those participants, 35% were controlled by 1 mg daily. The majority (88%) controlled on novel doses had no peripheral edema. Adherence to BP recording and reported adherence to medication was 84% and 94%, respectively. Patient retention was 96% (196/205). Treatment was well tolerated with no withdrawals from adverse events. Conclusions Personalized dose titration with amlodipine was safe, well tolerated, and efficacious in treating primary hypertension. The majority of participants achieved BP control on novel doses, and with personalization of dose there were no trial discontinuations due to drug intolerance. App‐assisted remote clinician dose titration may better balance BP control and adverse effects and help optimize long‐term care. Registration URL: clinicaltrials.gov. Identifier: NCT04559074.https://www.ahajournals.org/doi/10.1161/JAHA.123.030749amlodipinehome blood pressurehypertensionpersonalized dose titrationremote care |
spellingShingle | David J. Collier Mike Taylor Thomas Godec Julian Shiel Rebecca James Yasmin Chowdury Patrizia Ebano Vivienne Monk Mital Patel Jane Pheby Ruby Pheby Amanda Foubister Clovel David Manish Saxena Leanne Richardson James Siddle Gregor Timlin Paul Goldsmith Nicholas Deeming Neil R. Poulter Rhian Gabe Richard J. McManus Mark J. Caulfield Personalized Antihypertensive Treatment Optimization With Smartphone‐Enabled Remote Precision Dosing of Amlodipine During the COVID‐19 Pandemic (PERSONAL‐CovidBP Trial) Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease amlodipine home blood pressure hypertension personalized dose titration remote care |
title | Personalized Antihypertensive Treatment Optimization With Smartphone‐Enabled Remote Precision Dosing of Amlodipine During the COVID‐19 Pandemic (PERSONAL‐CovidBP Trial) |
title_full | Personalized Antihypertensive Treatment Optimization With Smartphone‐Enabled Remote Precision Dosing of Amlodipine During the COVID‐19 Pandemic (PERSONAL‐CovidBP Trial) |
title_fullStr | Personalized Antihypertensive Treatment Optimization With Smartphone‐Enabled Remote Precision Dosing of Amlodipine During the COVID‐19 Pandemic (PERSONAL‐CovidBP Trial) |
title_full_unstemmed | Personalized Antihypertensive Treatment Optimization With Smartphone‐Enabled Remote Precision Dosing of Amlodipine During the COVID‐19 Pandemic (PERSONAL‐CovidBP Trial) |
title_short | Personalized Antihypertensive Treatment Optimization With Smartphone‐Enabled Remote Precision Dosing of Amlodipine During the COVID‐19 Pandemic (PERSONAL‐CovidBP Trial) |
title_sort | personalized antihypertensive treatment optimization with smartphone enabled remote precision dosing of amlodipine during the covid 19 pandemic personal covidbp trial |
topic | amlodipine home blood pressure hypertension personalized dose titration remote care |
url | https://www.ahajournals.org/doi/10.1161/JAHA.123.030749 |
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