Condition category
Circulatory System
Date applied
09/07/2018
Date assigned
12/07/2018
Last edited
12/07/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
White coat hypertension is when a patient has raised blood pressure when they are in a clinic setting but normal blood pressure at home. At present, white coat hypertension isn’t treated, but previous research has suggested that there might be some benefit to treating it in relation to conditions affecting the heart and blood vessels. This study is looking at whether it is possible to run a trial to treat white coat hypertension in older patients with blood pressure lowering drugs.

Who can participate?
Patients aged 75 and over with white coat hypertension

What does the study involve?
Participants are randomly allocated to blood pressure lowering treatment for 12 months or no treatment. There are required visits to the GP every 2 months throughout the 12-month period and participants are asked to keep a diary of any ailments that they experience during the study.

What are the possible benefits and risks of participating?
There are no specific benefits to the participant. However, research delivers wider benefits to society and this study may help to improve care for others with a similar condition in the future. Information gathered in this trial will help develop the design and delivery of the full trial.

Where is the study run from?
1. Brockwood Medical Practice (UK)
2. Cossington House Surgery (UK)
3. Furnace Green Surgery (UK)
4. Henfield Medical Centre (UK)
5. Mid Sussex Healthcare (UK)
6. Newton Place Surgery (UK)
7. Northbourne Medical Centre (UK)
8. Park Road Surgery (UK)
9. Stone Cross Surgery (UK)
10. Trinity Medical Centre (UK)
11. Woodbridge Hill Surgery (UK)

When is the study starting and how long is it expected to run for?
April 2018 to April 2021

Who is funding the study?
Dunhill Medical Trust (UK)

Who is the main contact?
Dr Colin McAlister
bsctu@bsms.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Colin McAlister

ORCID ID

Contact details

Brighton & Sussex Clinical Trials Unit
Room 204 Bevendean House
University of Brighton
Falmer
BN1 9PH
United Kingdom
+44 (0)1273 641445
bsctu@bsms.ac.uk

Additional identifiers

EudraCT number

2017-004004-22

ClinicalTrials.gov number

Protocol/serial number

37147

Study information

Scientific title

A multi-centred, open label, randomised study assessing the cardiovascular outcomes following treatment of white coat hypertension with established anti-hypertensive drugs versus standard of care in the very elderly - feasibility study

Acronym

HYVET 2

Study hypothesis

The HYVET 2 study is looking at whether it is possible to treat White Coat Hypertension in older patients with blood pressure lowering drugs. White Coat Hypertension is a raised blood pressure when you are in a clinic setting however, your blood pressure at home is normal. At present, White Coat Hypertension isn’t treated, however, previous research has suggested that there might be some benefit to treating White Coat Hypertension in relation to conditions affecting the heart and blood vessels. We want to investigate this further.

This is a multi-centre, open-label study assessing the feasibility of conducting a randomised controlled trial to treat white coat hypertension in the very elderly.

Ethics approval

London – Westminster REC, 03/04/2018, ref: 18/LO/0104

Study design

Randomised; Interventional; Design type: Treatment, Drug

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Specialty: Primary Care, Primary sub-specialty: Ageing; UKCRC code/ Disease: Cardiovascular/ Hypertensive diseases

Intervention

It will entail a 1:1 randomisation of patients to a treatment arm with established antihypertensive drugs (indapamide and perindopril) and control arm (no treatment) which is current standard of care. This design will gather preliminary information on the intervention and the feasibility of conducting a full-scale randomised controlled trial. Recruitment will take place in GP surgeries.

Once potential participants have been identified through database search and mailouts or opportunistic recruitment, the participant will be invited in to consent for the trial and have a clinic blood pressure measurement. Within the next 2 weeks (+/- 7 days) the participant will return to the GP surgery for cognitive function assessments, review of past & current medical history, review of concomitant medications, another clinic blood pressure measurement, 24 hours ABPM (Ambulatory Blood Pressure Monitoring) and HBPM (Home Blood Pressure Monitoring), routine blood tests (biochemistry and haematology) and a 12 lead ECG. This will constitute the screening visits (visits 1 and 2).

Following visits 1 and 2, at Baseline (Visit 3) which is a further two weeks later +/-7 days) the particpant will be randomised to either the treatment arm or no treatment (current standard of care). An NHS prescription will then be written and given to the participant. Frailty assessments, an assessment of concomitant medications, adverse events, clinic blood pressure and other routine baseline data will be performed.

At Visits 4 and 5 (Weeks 12, 20 +/-7 days) the participant will be expected to return to the GP surgery for a clinic blood pressure measurement, assessment of adverse events and concomitant medications, HBPM, another prescription if required and a pill count of unused tablets or empty packaging.

At Visit 6 (Week 28 +/- 7 days) the participant will be required to return to the GP surgery for review of concomitant medications and adverse events, clinic blood pressure measurement, ABPM, HBPM, routine bloods (biochemistry and haematology), 12 lead ECG, prescription if required and an adherence check (pill count).

At Visits 7 and 8 (Weeks 36 and 44 +/- 7 days) the participant will be expected to come in to the GP surgery for a clinic blood pressure measurement and an assessment of concomitant medications and adverse events.

At Visit 9 (Week 52 +/- 7 days), the participant will be required to return to the GP surgery for cognitive function assessment and frailty assessments, review of concomitant medications and adverse events, clinic blood pressure measurement, HBPM, routine bloods (biochemistry and haematology), 12 lead ECG and an adherence check (pill count).

At Visit 10 (Week 60 +/- 7 days) the participant will be expected to come in to the GP surgery for a clinic blood pressure measurement, an assessment of concomitant medications and adverse events. In addition, 10 participants will be interviewed regarding their experience by members of the Patient and Public Involvement group.

Extra visits might be scheduled by the principal investigator, as appropriate, based on clinical requirement.

Follow up information on all participants will be sought after 2 years from the end of trial participation by reviewing the GP records to determine whether the participant is alive or deceased and whether they have experienced any cardiovascular outcomes.

Intervention type

Drug

Phase

Not Applicable

Drug names

Indapamide, perindopril

Primary outcome measure

HYVET 2 is a feasibility study which will focus on the following outcomes:
1. The estimated proportion of eligible patients that can be recruited from initial screening by reviewing Screening Logs to determine the proportion of screened patients eligible for recruitment on an ongoing basis
2. The effectiveness of different methods of identifying/recruiting patients - search and mail out, opportunistic recruitment and posters/adverts are included in the protocol design
3. The willingness of GPs to recruit and randomise patients, assessed by getting feedback from Primary Care team and GPs directly
4. The willingness of patients to be randomised, assessed by reviewing Screening Logs to determine the proportion of screened patients eligible for recruitment on an ongoing basis
5. The recruitment rate over the trial duration and the proportion of eligible patients that provide consent on an ongoing basis
6. Adherence to the treatment protocol by performing pill counts at each visit
7. The proportion withdrawing and reason for withdrawal, assessed on an ongoing basis
8. The opportunities for PPI (patient and public involvement) in the research design and its subsequent conduct and dissemination. A lay member will sit on the TSC and a PPI panel will review patient facing documents
9. Incidence of cardiovascular events by assessing the composition of cardiovascular events on an ongoing basis
10. Ambulatory and home blood pressure (mmHg) measured on an ongoing basis

Secondary outcome measures

-

Overall trial start date

23/04/2018

Overall trial end date

22/04/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients ≥75 years of age
2. Clinic sitting systolic BP ≥150 mmHg but <200 mmHg and diastolic BP <110 mmHg
3. Established diagnosis of white coat hypertension - confirmed if the mean ambulatory day time average systolic BP is <135 mmHg and diastolic BP is <85 mmHg (from at least 14 measurements) or for HBPM from BP readings twice a day for at least 5 days (ideally 7 days) at baseline
4. Not taken antihypertensive drug therapy within the last 6 months
5. Capacity to consent
6. Provision of documented informed consent
7. Ability to comply with the protocol and additional study visits and assessments

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Planned Sample Size: 100; UK Sample Size: 100

Participant exclusion criteria

1. Contraindication to the use of indapamide MR and perindopril in accordance with the summary of product characteristics
2. Regular non-steroidal anti-inflammatory drug (NSAID) use. Regular use being defined by the local GP with consideration to cardiovascular risk and blood pressure
3. Hypertensive emergency
4. Secondary hypertension
5. Postural hypotension (postural drop in systolic BP> = 20 mmHg or postural symptoms at screening)
6. Any stroke or myocardial infarction in the previous 6 months
7. Heart failure requiring treatment with drugs having an antihypertensive effect
8. Previous documented evidence of gout
9. eGFR less than 30ml/min
10. Montreal cognitive assessment score (MoCA) < 22
11. Life expectancy < 1 year due to malignancy or chronic disease

Recruitment start date

16/07/2018

Recruitment end date

15/07/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Brockwood Medical Practice
Brockham Surgery Tanners Meadow
Brockham
RH3 7NJ
United Kingdom

Trial participating centre

Cossington House Surgery
51 Cossington Road
Canterbury
CT1 3HX
United Kingdom

Trial participating centre

Furnace Green Surgery
50 The Glade Furnace Green
Crawley
RH10 6JN
United Kingdom

Trial participating centre

Henfield Medical Centre
Deer Park
Henfield
BN5 9JQ
United Kingdom

Trial participating centre

Mid Sussex Healthcare
Hurstpierpoint Health Centre Mid Sussex Health Care Trinity Road
Hurstpierpoint
BN6 9UQ
United Kingdom

Trial participating centre

Newton Place Surgery
Newton Road
Faversham
ME13 8FH
United Kingdom

Trial participating centre

Northbourne Medical Centre
193A Upper Shoreham Road
Shoreham-by-Sea
BN43 6BT
United Kingdom

Trial participating centre

Park Road Surgery
143 Park Road
Camberley
GU15 2NN
United Kingdom

Trial participating centre

Stone Cross Surgery
Mimram Road
Stone Cross
BN24 5DZ
United Kingdom

Trial participating centre

Trinity Medical Centre
1 Goldstone Villas
Hove
BN3 3AT
United Kingdom

Trial participating centre

Woodbridge Hill Surgery
1 Deerbarn Road
Guildford
GU2 8YB
United Kingdom

Sponsor information

Organisation

University of Sussex

Sponsor details

c/o Dr Antony Walsh
Research Governance Officer
Research and Enterprise Services
Falmer House
Brighton
BN1 9QF
United Kingdom
+44 (0)1273 872748 Internal Extension: 2748
researchsponsorship@sussex.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Dunhill Medical Trust; Grant Codes: R541/0217

Alternative name(s)

DMT

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

22/04/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes