Preliminary baseline analysis of 328 adults randomized to fixed triple therapy versus high-dose dual therapy showed balanced baseline office blood pressure (149.3 vs 148.9 mmHg).
RCT (n=328)
Open-label with blinded endpoint assessment
1:1
Yes
Does low-to-moderate-dose fixed triple therapy improve blood pressure and arterial stiffness compared with high-dose fixed dual therapy in adults with uncontrolled hypertension?
The NEXT Trial is an ongoing study evaluating whether early intensification with fixed triple therapy improves blood pressure control and vascular parameters compared to conventional dual escalation.
Objective: To evaluate whether low-to-moderate-dose fixed triple therapy results in greater reductions in peripheral and central blood pressure and pulse wave velocity, and improvement in flow-mediated dilation, compared with moderate-to-high-dose dual therapy patients with uncontrolled hypertension.Design and method: This is a national, multicenter, prospective, randomized, open-label trial with blinded endpoint assessment (PROBE design) and two parallel treatment arms. The multicenter participation across Brazilian regions supports real-world applicability. Adults with hypertension uncontrolled on low-dose dual therapy and office blood pressure over 140 over 90 mmHg are eligible. Participants are randomized in a one-to-one ratio to receive either a low-to-moderate-dose triple combination or high-dose fixed dual therapy once daily for 90 days. Peripheral and central blood pressure and flow-mediated dilation are assessed using validated devices. Arterial stiffness is evaluated by pulse wave velocity, and endothelial function by flow-mediated dilation in a predefined subgroup. The primary endpoints are changes from baseline to day 90 in peripheral and central blood pressure and arterial stiffness. Secondary outcomes include blood pressure control and change in endothelial function. Analyses follow intention-to-treat principle. Results: Since August 2025, 328 participants from six centers across different Brazilian regions have been enrolled and included in this preliminary baseline analysis. Of these, 300 have completed the 90-day follow-up to date, indicating high retention and feasibility. Overall, 63.7% were women and 27.4% were aged over 65 years. The mean age was 56.85 ± 12.1 years. At randomization, office blood pressure values were 148.9 ± 16.0 mmHg in the dual therapy group and 149.3 ± 16.2 mmHg in the triple therapy group (p=0.831), indicating balanced baseline levels. Diabetes was present in 29.0% of participants, dyslipidemia in 35.7%, and the mean body mass index was 31.2 ± 6.0 kg/m2, highlighting a population with substantial cardiometabolic risk and unmet blood pressure control needs. These baseline data are preliminary and current as of February 20, 2026. Conclusions: The NEXT Trial will determine whether early intensification with fixed triple therapy improves blood pressure control and vascular parameters compared with conventional dual escalation, with potential implications for future hypertension management strategies.
Oliveira et al. (2026) conducted an RCT in Uncontrolled hypertension (n=328). Fixed triple therapy vs. High-dose fixed dual therapy once daily was evaluated on Changes from baseline to day 90 in peripheral and central blood pressure and arterial stiffness. Preliminary baseline analysis of 328 adults randomized to fixed triple therapy versus high-dose dual therapy showed balanced baseline office blood pressure (149.3 vs 148.9 mmHg).