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Clinical Trial 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.


Clinical Trial Description

Given the urgent need for effective monitoring and medical management of hypertension during the COVID-19 pandemic, this study will test the feasibility of remote screening and onboarding to remote medical management of hypertension utilizing personalised digital diary record assisted optimisation of Blood Pressure control. Having remote screened a large number of participants, we then test the effect of a very gentle addition of amlodipine 1mg/ml oral solution to the regimes of a subgroup of asymptomatic participants with inadequate BP control. The majority of participants screened for the study will continue in follow-up and may be offered further developments as may be possible through development of the digital diary and a more comprehensive adaptive protocol which allows for further interventions (such as stop meds at onset of symptoms, or swap on or off ACE/ARB medications etc). Remote monitoring of blood pressure has been shown in times of normal healthcare access to improve blood pressure control, we will assess if the digital diary allows us to help during lockdown/reduced healthcare access and improve blood pressure with amlodipine without the need for blood tests or social contact. Amlodipine is a calcium-channel blocking drug which reduces blood pressure by relaxing blood vessels (especially veins) but this same effect makes it prone to causing fluid accumulation (oedema) in the lower limbs. There is a large amount of evidence on its effectiveness and safety in reducing blood pressure and in treating stable angina. There appears to be a close relationship between wanted and unwanted effects. Finding the best dose of amlodipine for a patient could be useful in optimizing their blood pressure treatment. At present the tablet doses available are only 5mg and 10mg in the UK. The present study will also investigate the tolerability of side effects and the relationship of these to the prescribed dose of amlodipine. It will measure the side effects of ankle swelling, headache and any other reported side effects using visual analogue scales. The study will utilise a selection of questionnaires to investigate the relationship between participant beliefs about medicines and participants' adherence. The hypothesis of the study is that participants' tolerability of side effects (as measured by VAS) will be related to their beliefs about the necessity of medication (necessity concerns), their concerns about side effects and their adherence to medication. Participants with uncontrolled blood pressure (systolic =>140 mmHg and/or diastolic =>90 mmHg) on their existing prescription antihypertensive (>= 1 drug) are eligible for the interventional arm of this study. This interventional arm of this study will assess introduction and titration of amlodipine doses within the current maximum licensed dose of 10mg (although higher doses are used in specialist clinics for selected participants). Amlodipine liquid formulation (oral solution) will be used to permit dosing in 1-2mg intervals for optimization of blood pressure control and side effects. Participants will use their standard home blood pressure monitors (a home blood pressure monitor can be provided as appropriate) and will be asked to measure their blood pressure in the morning (three readings) before taking their antihypertensive medication (trough treatment) and again in the evening (three readings). Participants will participate in remote teleconference consultations (telephone or electronic platform according to participant preference and familiarity, such as Zoom/MS Teams/ WhatsApp/ Facetime) with the William Harvey Clinical Research Centre (WHCRC) at least 2-weekly, following initial (remote) screening with clinical history taking, review of home blood pressure measurements and a thorough review of all information reported by the participant in the digital diary from a 5 day run-in period (see Section 11.6). Remote consultations remain frequent for those participants with poor BP control, but will be less frequent (monthly) for those who have stable blood pressure (defined as above BP<= 140/90) and are followed in the observational arm of the study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04559074
Study type Interventional
Source Queen Mary University of London
Contact
Status Completed
Phase Phase 4
Start date October 23, 2020
Completion date November 19, 2021

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