Treatment of White Coat HYpertension in the Very Elderly Trial (HYVET 2) - Feasibility of a Randomized Controlled Trial (Study Protocol)

• Main Authors: Michael Okorie, Khalid Ali, Stephen Bremner, Nigel Beckett, Stephen Jackson, Richard Quirk, Colin McAlister, Nicky Perry, John Potter, Christopher Bulpitt, Chakravarthi Rajkumar
• Format: Article
• Language: English
• Published: Atlantis Press 2019-11-01
• Series: Artery Research
• Subjects: White coat hypertension; treatment; feasibility study; very elderly
• Online Access: https://www.atlantis-press.com/article/125922031/view

The results of HYpertension in the Very Elderly Trial (HYVET) were crucial in providing evidence of benefit of the treatment of hypertension in those 80 years or older. Following a subsequent sub study analysis of the HYVET data there is a suggestion that 50% of patients in the main study had White Coat Hypertension (WCH), defined as clinic BP readings >140/90 mmHg and ambulatory BP readings <135/85 mmHg. Currently, definitive evidence in support of treatment for such individuals is not available. HYVET 2 has been designed in order to assess the feasibility of conducting a randomized controlled trial which might determine whether the treatment of WCH in the very elderly is clinically beneficial. One hundred participants aged ≥75 years diagnosed with WCH will be recruited from General Practices (GPs) in UK. Randomization will be 1:1 to a treatment arm (indapamide and perindopril) and control arm (no treatment) and follow up will be for 52 weeks. HYVET 2 will report on feasibility outcomes including participant recruitment, adherence and withdrawal rates, willingness of GPs to recruit and randomize patients and the frequency of a composite of cardiovascular events. Simple descriptive statistics will be presented.