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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Main Authors: 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
Format: Article
Language:English
Published: Wiley 2024-02-01
Series:Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease
Subjects:
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.
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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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