Personalised Electronic Record Supported OptimisatioN when ALone for Patients with Hypertension- Pilot Study for Remote Medical Management of Hypertension During the COVID-19 Pandemic - PERSONAL-COVIDBP

Queen Mary University of London0 个研究点目标入组 1,000 人开始时间: 2020年6月8日最近更新: 2020年8月3日

适应症

试验速览

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•1. Age =18 years.
•2. Informed consent.
•3. Possession of a working smartphone that the participant is able to independently use.
•4. Smartphone to support iOS versions 10.0 and newer or to support Android versions 5.0 (Lollipop) and newer.
•5. Smartphone to have minimum storage space required to install the e-diary: 250MB.
•6. The participant's smartphone must have enough memory to run the e-diary.
•7. Either a) Confirmed diagnosis of hypertension by NICE/BIHS criteria on either 24h ABPM or repeated home measures of blood pressure.
•Or b) Current treatment with antihypertensive medication.
•For the intervention study cohort
•1. Sub-optimal blood pressure control defined as average systolic blood pressure of 140mmHg or greater, and/or average diastolic blood pressure of 90mmHg or greater during the 5 days run-in period.
•2. Stable antihypertensive medication during the assessment of eligibility.
•For the observational study cohort
•1. Average systolic blood pressure of less than 140mmHg and/or average diastolic blood pressure of less than 90mmHg during the 5 days run-in period
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 185
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•1. Known severe adverse reaction to amlodipine.
•2. Currently receiving >=10mg /day amlodipine.
•3. Participation in another clinical trial, where the patient has received IMP in the last three months, with the exception of the MRC Aim-Hy study (IRAS: 199550, REC: 16/EE/0294) where patients can be screened after 6 weeks from final visit.
•4. Pregnant or lactating or female of childbearing potential not using adequate contraception (defined as oral contraceptive pill, IntraUterine Device, double barrier methods or abstinence as a clearly defined lifestyle choice).
•5. Patients who have too limited or no understanding of spoken and/or written English in the opinion of the investigator
•6. Patients who have hypersensitivity to dihydropyridine derivatives, amlodipine or to any of the excipients.
•7. Patients with obstruction of the outflow tract of the left ventricle (e.g. high grade aortic grade stenosis).
•8. Patients with a known intolerance of fructose, sugar, glycerol, maltitol liquid.
•(Liquid amlodipine is classed as sugar free, whereas the standard tablet contains lactose).
•9. Co-morbidities incompatible with study participation e.g. that result in a participant being unable to complete daily entries satisfactorily via his/her smartphone.

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