Remote monitoring of blood pressure in patients with high blood pressure during the COVID-19 pandemic

Not Applicable

Completed

• Conditions: High blood pressure; Circulatory System; Hypertension

• Registration Number: ISRCTN16393332
• Lead Sponsor: Queen Mary University of London

Brief Summary

2024 Results article in https://doi.org/10.1161/JAHA.123.030749 (added 12/02/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-24
• Study Completion: 2021-07-31
• Last Update Posted: 27 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Age =18 years
2. Informed consent
3. Possession of a working smart phone that 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 digital diary: 250MB
6. Smartphone must have enough memory to run the digital diary
7. Either a) 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 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 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

Exclusion Criteria

1. Current infection, or symptoms suggestive of SARS-2 COVID-19 at the time of screening (rescreening when recovered is allowed).
2. Known severe adverse reaction to amlodipine
3. Currently receiving >=10mg /day amlodipine
4. 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
5. 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)
6. Participants who have too limited or no understanding of spoken and/or written English in the opinion of the investigator
7. Participants who have hypersensitivity to dihydropyridine derivatives, amlodipine or to any of the excipients
8. Participants with obstruction of the outflow tract of the left ventricle (e.g. high grade aortic grade stenosis)
9. Participants with a known intolerance of fructose, sugar, glycerol, maltitol liquid (Liquid amlodipine is classed as sugar free, whereas the standard tablet contains lactose)
10. 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
11. Participants lacking capacity
12. Unstable Heart failure (e.g. after myocardial infarction)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Systolic blood pressure (mmHg/sphygmomanometer) at baseline and end of treatment in the intervention group

Secondary Outcome Measures

Name	Time	Method
1. Blood pressure (mmHg) measured using sphygmomanometer daily SBP/DBP at baseline to end of treatment.<br>2. Tolerability of side effects of amlodipine measured using reports of side effects using digital diary at this will be assessed using daily diary completion data<br>3. Participant's beliefs about medicines measured using collection of data on participant’s beliefs in the the Beliefs about medicines questionnaire, from baseline to end of treatment<br>4. Adherence to medicine measured using the questionnaires: Extence of Adherence, and the Making Medicines Work For You to medication at baseline to end of treatment <br>5. Quality of life measured using data from the questionnaire EQ5D. at baseline to end of treatment<br>6. SARS-CoV-2 COVID-19 symptoms and their timing measured using SARS-CoV-2 infection status as determined from health records. Rx (where possible) and BP from digital diary and baseline record