Personalised Electronic Record Supported Optimisation When Alone for Patients With Hypertension

NCT04559074 | Completed Phase 4

• 4 other identifiers: 283209PERSONAL-Covid BP2020-002494-1016393332
• Study Type: interventional
• Target: 343
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (3)

• Mean change in daily DBP

  3 months

• Difference between mean changes of blood pressure

  3 months

• Collect data on tolerability / side effects

  3 months

Study Arms (2)

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.

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.

Interventions

Amlodipine DRUG

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.

Interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Queen Mary University of London: lead
• Closed Loop Medicine Ltd: collaborator
• Innovate UK: collaborator

Study Sites (2)

William Harvey Research Institute Clinical Research Centre, Queen Mary University of London

London, London - City of London, EC1m 6BQ, United Kingdom

Location

Queen Mary University London

London, EC1M 6BQ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 38323513 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• David Collier

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 22, 2020
• Study Start: October 23, 2020
• Primary Completion: November 10, 2021
• Study Completion: November 19, 2021
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)