Long-term efficacy and safety of rehabilitation in patients with pulmonary arterial hypertension: the FONCE-HTAP randomized controlled trial.

RATIONALE: Pulmonary arterial hypertension (PAH) leads to heart failure and impaired exercise capacity. Rehabilitation may improve exercise tolerance, but most previous trials were short-term and open-label.

OBJECTIVES

To assess the 12-month efficacy and safety of a 3-month supervised rehabilitation program in PAH.

MEASUREMENTS AND MAIN

RESULTS

Stable patients from nine French PAH centers were enrolled in a prospective cohort without mention of rehabilitation, and thereafter randomized using a Zelen design either to usual follow-up or to a supervised 3-month rehabilitation program, following a second consent for the latter group. The primary endpoint was endurance time at 75% of maximal workload during cardiopulmonary exercise testing at 12 months (NCT02579954).Between 2015 and 2022, 49 patients were enrolled and 47 randomized (mean age 54.7 years; 27 females; 35 idiopathic PAH; mean mPAP 37.1 mmHg; PVR 5.7 UW; CI 3.0 L/min/m2). Twenty-one patients were assigned to rehabilitation. At baseline, 32 were at low risk, with preserved functional capacity (31 had 6-min walk distance >440 m). Mean (SD) endurance time was 8.7 (8.0) min in the rehabilitation group and 8.1 (4.8) min in controls. At 12 months, mean endurance time was 16.8 ± 20.0 minutes in the rehabilitation arm versus 8.0 ± 7.2 minutes in the control arm (adjusted p = 0.047). Clinical worsening risk tended lower with rehabilitation (RR 0.17, 95%CI 0.02-1.27; p = 0.055). No deaths occurred.

CONCLUSIONS

In this multicenter trial using a design limiting performance bias, a 3-month supervised rehabilitation program significantly improved exercise endurance at 12 months and may reduce clinical worsening.