Efficacy and safety of macitentan in Fontan-palliated patients: 52-week randomized, placebo-controlled RUBATO phase 3 trial and open-label extension.
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Author
Clift, PaulBerger, Felix
Sondergaard, Lars
Antonova, Petra
Disney, Patrick
Nicolarsen, Jeremy
Thambo, Jean-Benoît
Pajak, Lidia Tomkiewicz
Wang, Jou-Kou
Jensen, Annette Schophuus
Efficace, Michela
Friberg, Michael
Haberle, Diana
Walter, Verena
d'Udekem, Yves
Publication date
2024-08-29Subject
Cardiology
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Patients aged ≥12 years, New York Heart Association functional class II/III, underwent total cavopulmonary connection >1 year pre-screening and showed no signs of Fontan failure/clinical deterioration. In RUBATO-DB, primary efficacy endpoint was change in peak oxygen consumption (VO2) from baseline to week 16; secondary endpoints were change from baseline over 52 weeks in peak VO2 and change in mean count/minute of daily physical activity via accelerometer (PA-Ac) from baseline to week 16. Safety was assessed throughout both studies.Citation
Clift P, Berger F, Sondergaard L, Antonova P, Disney P, Nicolarsen J, Thambo JB, Pajak LT, Wang JK, Jensen AS, Efficace M, Friberg M, Haberle D, Walter V, d'Udekem Y. Efficacy and safety of macitentan in Fontan-palliated patients: 52-week randomized, placebo-controlled RUBATO phase 3 trial and open-label extension. J Thorac Cardiovasc Surg. 2024 Aug 29:S0022-5223(24)00773-6. doi: 10.1016/j.jtcvs.2024.08.039. Epub ahead of print. PMID: 39216715.Type
ArticlePMID
39216715Publisher
Mosbyae974a485f413a2113503eed53cd6c53
10.1016/j.jtcvs.2024.08.039