A Fixed-Dose Triple-Combination Therapy for the Initial Steps of Hypertension Treatment: Protocol for the NEXT RandomizedClinical Trial

by Prateek Chopra | June 15, 2026 | Cardiology Conferences | ESH 2026

Research Objective:

Evaluate whether low-to-moderate-dose fixed-dose triple therapy improves peripheral and central blood pressure, arterial stiffness, and endothelial function compared with moderate-to-high-dose dual therapy in patients with uncontrolled hypertension.

Study Design:

  • National, multicenter, prospective, randomized, open-label trial with blinded endpoint assessment (PROBE design).
  • Two parallel treatment arms: low-to-moderate-dose triple combination vs high-dose dual therapy once daily for 90 days.
  • Eligibility: Adults with uncontrolled hypertension on low-dose dual therapy, office BP >140/90 mmHg.
  • Primary endpoints: Changes in peripheral and central BP and arterial stiffness (pulse wave velocity) from baseline to day 90.
  • Secondary endpoints: BP control and endothelial function (flow-mediated dilation).
  • Analyses were conducted using the intention-to-treat principle.

Patient Population and Baseline Characteristics:

  • 328 participants enrolled from six centers across Brazil; 300 completed the 90-day follow-up.
  • 63.7% women; 27.4% aged >65 years; mean age 56.85 ± 12.1 years.
  • Baseline office BP: dual therapy 148.9 ± 16.0 mmHg, triple therapy 149.3 ± 16.2 mmHg (p=0.831).
  • Comorbidities: diabetes 29.0%, dyslipidemia 35.7%; mean BMI 31.2 ± 6.0 kg/m².

Key Features and Rationale:

  • Multicenter design supports real-world applicability.
  • Focus on early treatment intensification with triple therapy to address unmet BP control and cardiometabolic risk.

The NEXT Trial is designed to determine whether early intensification with fixed triple therapy improves BP control, vascular parameters, and endothelial function compared with conventional dual therapy escalation, potentially informing future hypertension management strategies.

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