Laurent Bertoletti: Long Term Benefits and Safety of Rehabilitation in Pulmonary Arterial Hypertension
Laurent Bertoletti, University Professor-Hospital Practitioner at Jean Monnet University Saint-Etienne, shared a post on LinkedIn about a recent article he and his colleagues co-authored, published in Annals of the American Thoracic Society, adding:
”Patients with rare diseases deserve the highest scientific standards.
We believe that rehabilitation may be beneficial. But even a strong and widely shared clinical conviction does not constitute evidence. It is therefore our responsibility to evaluate this intervention using the most rigorous randomized methodology possible.
These two principles are at the heart of the FONCE-HTAP trial.
After more than 10 years of work, this academic multicenter randomized controlled trial, funded through the PHRC program by Direction générale de l’offre de soins (DGOS), has been published in the Annals of American Thoracic Society.
In 47 patients with stable pulmonary arterial hypertension recruited from 9 French centers, we evaluated the long-term effects of a 3-month supervised rehabilitation program.
Key findings:
- At 12 months, mean endurance time was 16.8 minutes in the rehabilitation group versus 8.0 minutes in the control group. The benefit therefore remained observable nine months after the end of the directly supervised period;
- No serious adverse event was attributed to the program;
- A reduction in the risk of clinical worsening was also observed. This encouraging but exploratory signal will need to be confirmed.
One of the main strengths of FONCE-HTAP lies in its methodology. The trial used a Zelen design. This approach helped limit performance bias, which is particularly difficult to avoid in trials assessing non-pharmacological interventions.
This publication also demonstrates what French academic clinical research can achieve.
FONCE-HTAP was made possible by PHRC-i funding from the French Ministry of Health, through DGOS, together with several additional private sources of support.
The study was coordinated from CHU de Saint-Etienne, with the involvement of the CIC 1408, Silvy Laporte, SAnté INgéniérie BIOlogie St-Etienne (SAINBIOSE) and Université Jean Monnet Saint-Etienne Campus Santé – Université Jean Monnet.
Above all, it illustrates the strength of the French pulmonary hypertension network RespiFil – Filière Santé Maladies Rares : Saint-Étienne, Lyon, Grenoble, Brest, Strasbourg, Besançon, Clermont-Ferrand, Montpellier and Paris worked together to bring this project to completion.
Vincent Cottin Cecile Tromeur Francis COUTURAUD David Montani David Hupin Céline Chapelle Carine ASSANTE and others.
Thank you to the patients, the investigators, the clinical research and rehabilitation teams, and to the Siel Bleu association.
Special thoughts go to Pr Christophe Pison and Marie Jondot.
Long-term efficacy and safety of rehabilitation in patients with pulmonary arterial hypertension: the FONCE-HTAP randomized controlled trial.”
Title: Long-term efficacy and safety of rehabilitation in patients with pulmonary arterial hypertension: the FONCE-HTAP randomized controlled trial
Authors: Laurent Bertoletti, Ségolène Turquier, Hélène Bouvaist, Cécile Tromeur, Irina Enache, Marie-France Seronde, Claire Dauphin, Remi Diesler, Marianne Noirclerc, Francis Couturaud, Souad Bezzeghoud, Carine Assante, Céline Chapelle, Clément Boissin, David Montani, Vincent Cottin, Christophe Pison, Frédéric Costes, David Hupin

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