Why the study?
It remains unknown whether upfront combination therapy leads to more rapid and sustained clinical benefits in children with various categories of pulmonary hypertension.
Does upfront combination therapy (sildenafil and bosentan) improve WHO functional class at 12 months compared to sildenafil alone in children with pulmonary hypertension?
Does upfront combination therapy (sildenafil and bosentan) improve WHO functional class at 12 months compared to sildenafil alone in children with pulmonary hypertension?
This paper describes the design of the Kids Mod PAH Trial, a multicenter Phase III trial evaluating whether upfront combination therapy improves outcomes in children with pulmonary hypertension.
Answers are grounded in this paper and cite their sources.
Supports exploration of up-front combination therapy in pediatric PH; leaves open confirmation via dedicated RCTs.
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Collaco et al. (2023) studied this question.
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