Treatment of white coat HYpertension in the very elderly trial (HYVET 2) - Feasibility of a randomized controlled trial (study protocol)

Abstract

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.