HypertensionPhase 4PERSONALCovdBPNCT04559074
Personalised Electronic Record Supported Optimisation When Alone for Patients With Hypertension
A Phase 4 study testing Amlodipine in people with Hypertension, run by Queen Mary University of London at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Amlodipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 343 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 23 Oct 2020to 19 Nov 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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).
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
William Harvey Research Institute Clinical Research Centre, Queen Mary University of London
London, London - City of London, EC1m 6BQ
Queen Mary University London
London, EC1M 6BQ
About this study
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
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.
Read the detailed 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.
- Conditions
- Hypertension
- Being tested
- Amlodipine
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmlodipineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | 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. Receives: Drug: Amlodipine |
| Observational | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reductions in blood pressure in participants with primary hypertension and inadequate BP control by up-titration of amlodipine in 1-2 mg increments.
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.
Measured: 3 months
Secondary outcomes (3)
Mean change in daily DBP
Other clinically significant blood pressure measures which related to difference in measured blood pressure between baseline and EOS
Measured: 3 months
Difference between mean changes of blood pressure
Difference between mean changes of blood pressure between interventional and observational cohorts.
Measured: 3 months
Collect data on tolerability / side effects
Reports of side effects using digital diary
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start23 Oct 2020
- Primary completion10 Nov 2021
- Study completion19 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 343 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Closed Loop Medicine Ltd, Innovate UK
- Responsible party
- Sponsor
- Investigators
- David Collier, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559074
- Sponsor's protocol ID
- 283209
- Other IDs
- PERSONAL-Covid BP, 2020-002494-10, 16393332, 283209
- Acronym
- PERSONALCovdBP
- Status last verified
- Feb 2024
- First submitted
- 26 Aug 2020
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Fully anonymised data will be shared with fellow researchers via conference presentation and via publication of the results in scientific journals. Pseudonymised data will be shared between the research teams named in the application.
Publications
Collier DJ, Taylor M, Godec T, Shiel J, James R, Chowdury Y, Ebano P, Monk V, Patel M, Pheby J, Pheby R, Foubister A, David C, Saxena M, Richardson L, Siddle J, Timlin G, Goldsmith P, Deeming N, Poulter NR, Gabe R, McManus RJ, Caulfield MJ. Personalized Antihypertensive Treatment Optimization With Smartphone-Enabled Remote Precision Dosing of Amlodipine During the COVID-19 Pandemic (PERSONAL-CovidBP Trial). J Am Heart Assoc. 2024 Feb 20;13(4):e030749. doi: 10.1161/JAHA.123.030749. Epub 2024 Feb 7.
PubMed 38323513
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04559074
- Acronym / sponsor ID
- PERSONALCovdBP / 283209
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 343 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- Closed Loop Medicine Ltd, Innovate UK
- Study start
- 23 Oct 2020 (actual)
- Primary completion
- 10 Nov 2021 (actual)
- Study completion
- 19 Nov 2021 (actual)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Drug: AmlodipineIntervention 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. |
| Observational | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmlodipineAmlodipine 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. | Drug | Interventional |
Primary outcome
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.
3 secondary outcomes
Mean change in daily DBP
Time frame: 3 months
Difference between mean changes of blood pressure
Time frame: 3 months
Collect data on tolerability / side effects
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Derived from this study: PubMed 38323513Collier DJ, Taylor M, Godec T, Shiel J, James R, Chowdury Y, Ebano P, Monk V, Patel M, Pheby J, Pheby R, Foubister A, David C, Saxena M, Richardson L, Siddle J, Timlin G, Goldsmith P, Deeming N, Poulter NR, Gabe R, McManus RJ, Caulfield MJ. Personalized Antihypertensive Treatment Optimization With Smartphone-Enabled Remote Precision Dosing of Amlodipine During the COVID-19 Pandemic (PERSONAL-CovidBP Trial). J Am Heart Assoc. 2024 Feb 20;13(4):e030749. doi: 10.1161/JAHA.123.030749. Epub 2024 Feb 7.
- Individual participant dataSharing planned: No. Fully anonymised data will be shared with fellow researchers via conference presentation and via publication of the results in scientific journals. Pseudonymised data will be shared between the research teams named in the application.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Collier principal investigator
Queen Mary University of London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amlodipine in people with Hypertension, run by Queen Mary University of London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04559074, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.