A Phase IV, 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
Trial acronym: HYVET-2
Description
Cardiovascular disease (mainly stroke and coronary artery disease) remains an important global cause of morbidity and mortality and hypertension is a major contributing risk factor, particularly in older people. The overall prevalence of hypertension in all adults in England is 28.6% and this compares with a prevalence of 65.6% in patients over 75 years of age. With an ageing population and the greatest expansion in population expected in the over 65 age group, hypertension will become a more prominent treatable and preventable cause of premature death.
There has been controversy regarding the appropriateness of treatment of hypertension in older people based on data from epidemiological studies, which suggest that there is a higher risk of death in patients over 80 years of age with lower Blood Pressure (BP). This notion has been challenged by data from the HYpertension in the Very Elderly Trial (HYVET) which showed that antihypertensive treatment in persons 80 years or older is beneficial. As a result, NICE guidelines recommend BP control to reduce cardiovascular risk, irrespective of the age of the patient.
Current NICE guidelines for the diagnosis and treatment of hypertension recommend the widespread use of ambulatory blood pressure monitoring (ABPM) in order to exclude the presence of white coat hypertension (WCH), as the benefits of treatment are unproven. WCH is defined as persistently raised clinic blood pressure readings (>140/90 mmHg) in individuals who have normal home or ABPM readings (<135/85 mmHg) and may affect up to 30% of the population, according to some studies. Evidence for a role for the active treatment of WCH has been contentious and it is as yet unknown whether the patients with WCH benefit from treatment.
Study design: Multi-centre, open-label study assessing the feasibility of conducting a randomised controlled trial to treat white coat hypertension in the very elderly.
Trial status: Closed
Chief Investigator: Professor Chakravarthi Rajkumar, BSMS, Audrey Emerton Building, Royal Sussex County Hospital, Eastern Road, Brighton BN2 5BE.
Start date: April 2018
End date: April 2021
Recruitment target: 100
Summary of study results: n/a
For further information contact:
E: bsctu@bsms.ac.uk