Personalised Electronic Record Supported Optimisation When Alone for Patients With Hypertension- Pilot Study for Remote Medical Management of Hypertension During the COVID-19 Pandemic
Hypertension
About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years.
- Informed consent.
- Possession of a working smart phone that participant is able to independently use.
- Smartphone to support iOS versions 10.0 and newer or to support Android versions 5.0 (Lollipop) and newer.
- Smartphone to have minimum storage space required to install the digital diary: 250MB.
- Smartphone must have enough memory to run the digital diary.
- Either:
- Participant account of a diagnosis of hypertension consistent with NICE/BIHS criteria on either 24h ABPM or repeated home measures of blood pressure, ideally prior to treatment.
Or •Current treatment with antihypertensive medication.
For the intervention study cohort
- 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.
- Stable antihypertensive medication during assessment of eligibility.
For the observational study cohort
• Average systolic blood pressure of less than 140mmHg and average diastolic blood pressure of less than 90mmHg during the 5 days run-in period
Exclusion Criteria:
- Current infection, or symptoms suggestive of SARS-2 COVID-19 at the time of screening (rescreening when recovered is allowed).
- Known severe adverse reaction to amlodipine.
- Currently receiving >=10mg /day amlodipine.
- Participation in another clinical trial, where the participant has received IMP in the last three months, with the exception of the MRC Aim-Hy study (IRAS: 199550, REC: 16/EE/0294) where participants can be screened after 6 weeks from final visit.
- 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).
- Participants who have too limited or no understanding of spoken and/or written English in the opinion of the investigator
- Participants who have hypersensitivity to dihydropyridine derivatives, amlodipine or to any of the excipients.
- Participants with obstruction of the outflow tract of the left ventricle (e.g. high grade aortic grade stenosis).
- Participants with a known intolerance of fructose, sugar, glycerol, maltitol liquid.
(Liquid amlodipine is classed as sugar free, whereas the standard tablet contains lactose).
- Co-morbidities incompatible with study participation e.g. that result in a participant being unable to complete daily entries satisfactorily via his/her smart phone.
- Participants lacking capacity .
- Unstable Heart failure (e.g. after myocardial infarction).
Sites / Locations
- Queen Mary University LondonRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Interventional
Observational
Intervention group will receive Amlodipine 1mg/ml Oral Solution; starting dose 1-2mg per day for patients not on amlodipine at entry. Participants will take the prescribed dosage daily. Dosage will be reviewed on a fortnightly basis and adjusted as necessary. The total duration is 3 months.
This group will record blood pressure readings and data on a daily basis for a total of 3 months. They will not take any medication. They will be reviewed on a monthly basis in consultations.