BASELINE DATA OF A 3-YEAR RANDOMIZED CONTROLLED TRIAL ASSESSING THE EFFECTS OF THE REDUCTION OF ANTIHYPERTENSIVE TREATMENT IN NURSING HOME RESIDENTS >80 YO. THE RETREAT FRAIL TRIAL

Objective: Although the benefits of blood pressure (BP) lowering treatments in patients over 80 years with preserved functional status have been shown, the benefits in treated hypertensive patients of this age-group with several co-morbidities and loss of functionality, remain controversial: data from observational studies show rather inverse relationships between BP and prognosis, whereas there is a total lack of interventional trials in these subjects. Design and method: RETREAT FRAIL is a multicenter randomized controlled trial aiming to evaluate the effect of the step-down of antihypertensive medications on all-cause mortality (mean follow-up, 36 months) in nursing home (NHs) residents over 80 years, treated with >1 antihypertensive drug and presenting an SBP<130 mmHg. The only clinical exclusion criterion was an estimated life expectancy <3 months. Enrolled patients were randomized into one of the 2 groups: treatment step-down or control group. In both groups, the follow-up is performed in the NHs every 2 months, including a comprehensive geriatric assessment every 6 months. Results: Between April 2019 and July 2022, 1048 patients (842 women), mean age 90±5, from 108 NHs were randomized (528 step-down and 520 controls). They were receiving at mean 9.4±3.4 different medications including 2.5±0.7 antihypertensive medications. Mean SBP: 118±11mmHg, DBP: 65±10 mmHg and HR: 71±12 bpm. Based on ADL, MMSE, and mobility criteria, 52% had severe loss of autonomy, 32 % partial loss of functionality and autonomy and 16% had preserved autonomy and functionality. No differences were observed for all these parameters between the 2 randomization groups. The 3-year follow-up of this trial will be completed June 2024. Conclusions: Despite the difficulties in NHs dramatically aggravated during the COVID-19 pandemic, we were able to complete the enrolment of the residents and to respect the follow-up protocol. RETREAT FRAIL will be the first randomized trial to provide information concerning the long-term effects of a progressive standardized down-titration of the BP lowering treatment in very old frail patient i.e. those who have so far been completely excluded from clinical trials.