Efficacy and safety of macitentan in Fontan-palliated patients: 52-week randomized, placebo-controlled RUBATO Phase 3 trial and open-label extension
The primary end point of RUBATO-DB was not met; macitentan did not improve exercise capacity versus placebo in patients with Fontan palliation. Macitentan was generally well tolerated over long-term treatment.
Authors
- Jean‐Benoît Thambo (ORCID: https://orcid.org/0000-0001-5738-965X)
- Michela Efficace
- Petra Antonová (ORCID: https://orcid.org/0000-0003-3272-7928)
- Michael Friberg
- Jou-kou Wang
- Lars Søndergaard (ORCID: https://orcid.org/0000-0001-8961-8226)
- Jeremy Nicolarsen
- Paul Clift (ORCID: https://orcid.org/0000-0001-8906-7647)
- Annette Schophuus Jensen (ORCID: https://orcid.org/0000-0003-4170-6416)
- Yves d’Udekem (ORCID: https://orcid.org/0000-0003-1851-7836)
- Felix Berger (ORCID: https://orcid.org/0000-0001-7881-1557)
- Patrick Disney
- D. A. Häberle
- Lidia Tomkiewicz Pająk
- Verena Walter
Institutions
- University of Copenhagen (DK)
- Jagiellonian University (PL)
- Providence Sacred Heart Medical Center (US)
- Royal Adelaide Hospital (AU)
- Children's National (US)
- Université de Bordeaux (FR)
- Charles University (CZ)
- Queen Elizabeth Hospital Birmingham (GB)
- Rigshospitalet (DK)
- Electrophysiology and Heart Modeling Institute (FR)
- Johnson & Johnson (Switzerland) (CH)
- Abbott (Canada) (CA)
- University Hospital in Motol (CZ)
- John Paul II Hospital (PL)
- Deutsches Herzzentrum der Charité (DE)
- National Taiwan University Hospital (TW)
- Institute of Cardiology (PL)
- Janssen (Italy) (IT)
- Charité - Universitätsmedizin Berlin (DE)
- Actelion (Switzerland) (CH)
Publication Details
- Journal
- Journal of Thoracic and Cardiovascular Surgery
- Published
- 2024-08-29
- DOI
- https://doi.org/10.1016/j.jtcvs.2024.08.039
- Citations
- 10
- Primary Topic
- Congenital Heart Disease Studies
- Type
- article
- Field-Weighted Citation Impact
- 3.87
Funders
- Actelion Pharmaceuticals