Adaptive blood pressure modulated atrial pacing in hypertensive HFpEF patients: a randomized, first-in-human study

Abstract Aims Heart failure with preserved ejection fraction (HFpEF) represents approximately 50% of all heart failure cases and lacks effective treatments. Chronotropic incompetence contributes to exercise intolerance in these patients. This study evaluated the safety and efficacy of blood pressure–adaptive atrial pacing (BPAP) versus standard bradycardia pacing (STD) in hypertensive patients with HFpEF. Methods In this prospective, double-blind, randomized, self-controlled crossover study, 16 patients (mean age 62.7±10.9 years; 6% female; LVEF 55.3±3.8%) with treated hypertension and implanted dual-chamber pacemakers underwent two 3-week treatment phases (BPAP and STD) in random order. The BPAP algorithm modulated atrial pacing rate in response to home blood pressure readings. Endpoints included Minnesota Living With Heart Failure (MLWHF) score, New York Heart Association (NYHA) class, 6-minute walk test (6MWT), and modified Bruce treadmill test. Results BPAP improved MLWHF score by an additional 15% from baseline (p=0.0288), whereas STD showed a non-significant 3% worsening. Exercise time increased significantly during BPAP (+83.2±55.6 s, p=0.005) but not during STD (+70.8±84.4 s, p=0.095). The 6MWT distance rose by 35.8±29.9 m during BPAP (p=0.003) versus minimal change with STD (+8.2±40.1 m, p=0.6). NYHA class improved in 55.6% of BPAP patients versus 11% with STD (p=0.0455). Mean heart rate was higher during BPAP (83.8±8.3 bpm) than STD (72.9±12.0 bpm, p0.0001), with no difference in systolic blood pressure (137.5±14.9 vs 138.6±14.0 mmHg, p=0.68). No adverse events occurred. Conclusions In hypertensive patients with HFpEF and implanted pacemakers, BPAP safely improved exercise capacity and functional status compared to standard pacing. The approach demonstrates feasibility of home-based blood pressure–modulated pacing for physiologic rate adaptation. (NCT06036186)