Personalised Electronic Record Supported Optimisation When Alone for Patients With Hypertension- Pilot Study for Remote Medical Management of Hypertension During the COVID-19 Pandemic

• Status: Recruiting
• Trial end date: 2021-07-31
• Target enrollment: 0
• Participant gender: All

Summary

This trial is focusing on blood pressure control for patients with high blood pressure (hypertension) during the COVID-19 pandemic when seeing a doctor for advice may be difficult. The study utilises remote consultations by telephone or video conferencing. Patients record blood pressure and data into an electronic diary on their phone which is reviewed in consultations every 2 weeks by a clinician. Medication for this trial is amlodipine as an oral solution which is uptitrated accordingly for patients receiving medication (anticipated 200). 800 patients will be in an observational group recording the same readings and will not receive any medication.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Queen Mary University of London
• Collaborators: Closed Loop Medicine Ltd; Innovate UK
• Treatments: Amlodipine

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).