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Abstract：
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.
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.
BACKGROUND: URL: clinicaltrials.gov. Identifier: NCT04559074.
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.
BACKGROUND: URL: clinicaltrials.gov. Identifier: NCT04559074.
摘要：
背景：PERSONAL-CovidBP（针对高血压患者的个性化电子记录支持的单独优化：COVID-19大流行期间高血压远程医疗管理的初步研究）试验的目的是评估在COVID-19大流行期间，智能手机远程精确给药氨氯地平以控制原发性高血压（BP）的有效性和安全性。
结果：这是一个开放的标签，远程,使用每日家庭自我监测血压的剂量滴定试验，药物剂量，以及链接的智能手机应用程序和远程监控的副作用。年龄≥18岁的未受控制的高血压（5-7天基线平均收缩压≥135mmHg或舒张压≥85mmHg）的参与者在14周内每天使用新的（1、2、3、4、6、7、8、9mg）和标准（5和10mg）剂量接受个性化氨氯地平剂量滴定。试验的主要结果是从基线到治疗结束的收缩压的平均变化。共纳入205名参与者，平均血压从142/87（收缩压/舒张压）降至131/81mmHg（降低11（95％CI，10-12）/7（95％CI，6-7）mmHg，P<0.001)。大多数参与者在新剂量下实现了血压控制(84%)；在这些参与者中，35％每天控制1毫克。大多数（88％）控制新剂量没有外周水肿。坚持BP记录和报告的药物依从性分别为84％和94％，分别。患者保留率为96%（196/205）。治疗耐受性良好，没有退出不良事件。
结论：氨氯地平个性化剂量滴定是安全的，良好的耐受性，有效治疗原发性高血压。大多数参与者在新剂量下实现了血压控制，随着剂量的个性化,没有因药物不耐受而导致的试验中止.应用辅助远程临床医生剂量滴定可以更好地平衡BP控制和不良反应，并有助于优化长期护理。
背景：URL：clinicaltrials.gov.标识符：NCT04559074。
结果：这是一个开放的标签，远程,使用每日家庭自我监测血压的剂量滴定试验，药物剂量，以及链接的智能手机应用程序和远程监控的副作用。年龄≥18岁的未受控制的高血压（5-7天基线平均收缩压≥135mmHg或舒张压≥85mmHg）的参与者在14周内每天使用新的（1、2、3、4、6、7、8、9mg）和标准（5和10mg）剂量接受个性化氨氯地平剂量滴定。试验的主要结果是从基线到治疗结束的收缩压的平均变化。共纳入205名参与者，平均血压从142/87（收缩压/舒张压）降至131/81mmHg（降低11（95％CI，10-12）/7（95％CI，6-7）mmHg，P<0.001)。大多数参与者在新剂量下实现了血压控制(84%)；在这些参与者中，35％每天控制1毫克。大多数（88％）控制新剂量没有外周水肿。坚持BP记录和报告的药物依从性分别为84％和94％，分别。患者保留率为96%（196/205）。治疗耐受性良好，没有退出不良事件。
结论：氨氯地平个性化剂量滴定是安全的，良好的耐受性，有效治疗原发性高血压。大多数参与者在新剂量下实现了血压控制，随着剂量的个性化,没有因药物不耐受而导致的试验中止.应用辅助远程临床医生剂量滴定可以更好地平衡BP控制和不良反应，并有助于优化长期护理。
背景：URL：clinicaltrials.gov.标识符：NCT04559074。
