HYVET 2: treatment of white coat hypertension in the very elderly
| ISRCTN | ISRCTN13127656 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13127656 |
| EudraCT/CTIS number | 2017-004004-22 |
| Secondary identifying numbers | 37147 |
- Submission date
- 09/07/2018
- Registration date
- 12/07/2018
- Last edited
- 12/03/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Stopped
- Condition category
- Circulatory System
Plain English summary of protocol
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?
Brighton & Sussex Clinical Trials Unit (UK), with trial sites throughout England
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 Nicky Perry, bsctu@bsms.ac.uk
Contact information
Scientific
Brighton & Sussex Clinical Trials Unit
Room 204 Bevendean House
University of Brighton
Falmer
BN1 9PH
United Kingdom
| Phone | +44 (0)1273 641469 |
|---|---|
| bsctu@bsms.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment, Drug |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study acronym | HYVET 2 |
| Study objectives | 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(s) | London – Westminster REC, 03/04/2018, ref: 18/LO/0104 |
| Health condition(s) or problem(s) studied | White coat hypertension |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 23/04/2018 |
| Completion date | 22/04/2021 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | Planned Sample Size: 100; UK Sample Size: 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 16/07/2018 |
| Date of final enrolment | 30/04/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Tanners Meadow
Brockham
RH3 7NJ
United Kingdom
Canterbury
CT1 3HX
United Kingdom
Furnace Green
Crawley
RH10 6JN
United Kingdom
Henfield
BN5 9JQ
United Kingdom
Mid Sussex Health Care
Trinity Road
Hurstpierpoint
BN6 9UQ
United Kingdom
Faversham
ME13 8FH
United Kingdom
Camberley
GU15 2NN
United Kingdom
Stone Cross
BN24 5DZ
United Kingdom
Hove
BN3 3AT
United Kingdom
Guildford
GU2 8YB
United Kingdom
Blackpool
FY5 3LF
United Kingdom
Brierfield
Nelson
BB9 5RZ
United Kingdom
Yatton
Bristol
BS49 4ER
United Kingdom
21 West Walk
Yate
Bristol
BS37 4AX
United Kingdom
Colchester
CO3 4LN
United Kingdom
Woodland Ave
Goole
DN14 6RU
United Kingdom
Brough
HU15 2UL
United Kingdom
Knaresborough
HG5 0NY
United Kingdom
Brough
HU15 1AY
United Kingdom
Hull
HU9 4AL
United Kingdom
Sponsor information
University/education
c/o Dr Antony Walsh
Research Governance Officer
Research and Enterprise Services
Falmer House
Brighton
BN1 9QF
England
United Kingdom
| Phone | +44 (0)1273 872748 Internal Extension: 2748 |
|---|---|
| researchsponsorship@sussex.ac.uk | |
"ROR" |
https://ror.org/00ayhx656 |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- The Dunhill Medical Trust, DMT
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 22/04/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. The grant requires the data to be made available as widely as possible to maximise potential benefits; however, the plan hasn't been determined. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 16/02/2020 | 17/02/2021 | No | No | |
| HRA research summary | 26/07/2023 | No | No |
Additional files
- ISRCTN13127656_BasicResults_16Feb2020.pdf
- Uploaded 17/02/2021
Editorial Notes
12/03/2021: The following changes have been made:
1. The scientific contact has been updated and the plain English summary has been updated accordingly.
2. The trial participating centre "Northbourne Medical Centre" has been removed.
17/02/2021: The basic results of this trial have been uploaded as an additional file.
12/05/2020: The trial status has been updated to "Stopped".
28/01/2020: The following changes have been made:
1. The recruitment end date has been changed from 31/12/2019 to 30/04/2020.
2. Cleveleys Group Practice, Pendle View Medical Centre, Mendip Vale Medical Practice, West Walk Surgery, The ColTe Partnership, The Bartholomew Medical Group, Gilberdyke Health Centre, Stockwell Road Surgery, The Ridings Medical Group and Diadem Medical Practice have been added to the trial participating centres.
14/08/2019: IPD sharing statement added.
09/08/2019: The recruitment end date was changed from 15/07/2019 to 31/12/2019.
22/03/2019: The condition was updated from "Specialty: Primary Care, Primary sub-specialty: Ageing; UKCRC code/ Disease: Cardiovascular/ Hypertensive diseases" to "Elevated blood-pressure reading, without diagnosis of hypertension".
