2 research outputs found
Identifying and treating resistant hypertension in PRECISION: A randomized longāterm clinical trial with aprocitentan
Abstract The design and baseline data of the PRECISION study, which evaluates the effect of the dual endothelin receptor antagonist aprocitentan on blood pressure (BP) in patients with resistant hypertension (RHT) are presented. The study is a blinded, randomized, parallelāgroup Phase 3 study and its threeāpart design assesses the shortāterm and sustained longāterm effects of aprocitentan on BP. Results are expected in 2022. Patients with uncontrolled BP (measured as unattended automated office BP) despite the use of three or more antihypertensive medications for at least 1 year were screened. They were switched to a singleātablet triple fixed combination antihypertensive therapy for at least 4Ā weeks before entering a singleāblind placebo runāin period. The 4āweek placebo runāin period further excluded placebo responders. The randomization period consisted of three sequential parts: (1) a 4āweek doubleāblind part with aprocitentan 12.5Ā mg, 25Ā mg, or placebo (1:1:1 ratio); (2) a 32āweek singleāblind part with aprocitentan 25Ā mg; and (3) a 12āweek randomized withdrawal part with aprocitentan 25Ā mg or placebo (1:1 ratio). The purpose was to demonstrate the BP lowering effect of aprocitentan in RHT (Part 1) and the persistence of this effect (Parts 2 and 3). Out of 1965 screened patients, 730 were randomized resulting in an overall inclusion failure rate of 62.8%. The most common reason for exclusion (44.4% of all screened patients) was failure to meet the BP inclusion criteria. These results underline the high proportion of pseudoresistant hypertension among patients referred for RHT