Personalised Electronic Record Supported Optimisation When Alone for Patients With Hypertension- Pilot Study for Remote Medical Management of Hypertension During the COVID-19 Pandemic
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04559074|
Recruitment Status : Recruiting
First Posted : September 22, 2020
Last Update Posted : November 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Drug: Amlodipine||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Personalised Electronic Record Supported Optimisation When Alone for Patients With Hypertension- Pilot Study for Remote Medical Management of Hypertension During the COVID-19 Pandemic|
|Actual Study Start Date :||October 23, 2020|
|Estimated Primary Completion Date :||April 30, 2021|
|Estimated Study Completion Date :||July 31, 2021|
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.
Amlodipine 1mg/ml Oral Solution; starting dose 1-2mg per day for patients not on amlodipine at entry; starting dose equivalent to current dose for patients on amlodipine at entry or at next 1-2mg dose step (according to clinical need based on the Investigator's judgement). Investigation of whether gradually increasing the dose of liquid amlodipine (can be an add-on to existing amlodipine tablets) in small increments (e.g. 1-2mg) will enable blood pressure control within the sequence 1mg, 2mg, 3mg, 4mg, 5mg, 6mg, 7mg, 8mg, 9mg to a maximum of 10mg amlodipine per day.
No Intervention: Observational
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.
- Reductions in blood pressure in participants with primary hypertension and inadequate BP control by up-titration of amlodipine in 1-2 mg increments. [ Time Frame: 3 months ]The primary objective of the study is to assess precision dosing of amlodipine to deliver reductions in blood pressure in participants with primary hypertension and inadequate BP control by up-titration of amlodipine in 1-2 mg increments.
- Mean change in daily DBP [ Time Frame: 3 months ]Other clinically significant blood pressure measures which related to difference in measured blood pressure between baseline and EOS
- Difference between mean changes of blood pressure [ Time Frame: 3 months ]Difference between mean changes of blood pressure between interventional and observational cohorts.
- Collect data on tolerability / side effects [ Time Frame: 3 months ]Reports of side effects using digital diary
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04559074
|Contact: David Collier||020 7882 firstname.lastname@example.org|
|Contact: CVC CTU||0207 882 email@example.com|
|Queen Mary University London||Recruiting|
|London, United Kingdom, EC1M 6BQ|
|Contact: Rebecca James firstname.lastname@example.org|
|Principal Investigator:||David Collier||Queen Mary University of London|