RESUMO
Pulmonary hypertension (PH) is a significant health problem that contributes to high morbidity and mortality in diverse cardiac, pulmonary, and systemic diseases in children. Evidence-based advances in PH care have been challenged by a paucity of quality endpoints for assessing clinical course and the lack of robust clinical trial data to guide pharmacologic therapies in children. While the landmark adult AMBITION trial demonstrated the benefit of up-front combination PH therapy with ambrisentan and tadalafil, it remains unknown whether upfront combination therapy leads to more rapid and sustained clinical benefits in children with various categories of PH. In this article, we describe the inception of the Kids Mod PAH Trial, a multicenter Phase III trial, to address whether upfront combination therapy (sildenafil and bosentan vs. sildenafil alone) improves PH outcomes in children, recognizing that marked differences between the etiology and therapeutic response between adults and children exist. The primary endpoint of this study is WHO functional class (FC) 12 months after initiation of study drug therapy. In addition to the primary outcome, secondary endpoints are being assessed, including a composite measure of time to clinical worsening, WHO FC at 24 months, echocardiographic assessment of PH and quantitative assessment of right ventricular function, 6-min walk distance, and NT-proBNP levels. Exploratory endpoints include selected biomarkers, actigraphy, and assessments of quality of life. This study is designed to pave the way for additional clinical trials by establishing a robust infrastructure through the development of a PPHNet Clinical Trials Network.
RESUMO
La menarquia es el inicio de la menstruaciòn causado por un incremento gradual en la secreciòn de hormona gonadotròfica, se conoce la incidencia de factores ètnico-geogràficos, nutricionales y hàbitos de vida como determinantes de la apariciòn de la menarquia. En este estudio se analizò la edad de presentaciòn de menarquia en un grupo de adolescentes de 10 a 18 años (n=87) en el que se obtuvo positividad en 22 personas de acuerdo a la edad en que fue encuestado. La media fue de 13 años con un rango entre los 11 a los 15 años. El mayor porcentaje se encontrò a los 14 años (45.45 por ciento) y en orden de frecuencia 13,12,11 y 15. Tambièn se corroboran los datos de peso y talla encontràndose que los casos que presentan menarquia siempre se encuentran por encima de la media de estos datos obtenidos en la muestra total...