Key result
Riociguat increased the mean 6-minute walking distance by 39 meters from baseline to week 12 compared to 0 meters for placebo in patients with persistent or recurrent pulmonary arterial hypertension after correction of congenital heart disease.
Why the study?
Does riociguat improve 6-minute walking distance and hemodynamics in patients with persistent or recurrent pulmonary arterial hypertension after correction of congenital heart disease?
RCT (n=35)
Double-blind
Randomized
Yes
Does riociguat improve 6-minute walking distance and hemodynamics in patients with persistent or recurrent pulmonary arterial hypertension after correction of congenital heart disease?
Mean Difference: 39
Absolute Event Rate: 39% vs 0%
Riociguat improved exercise capacity, pulmonary vascular resistance, and NT-proBNP in patients with persistent or recurrent PAH after complete repair of congenital heart disease.
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Supports riociguat for exercise capacity in post-repair PAH; extends prior trial data to this population.
Rosenkranz et al. (2015) conducted an RCT in Pulmonary arterial hypertension associated with congenital heart disease (n=35). Riociguat vs. Placebo was evaluated on Change from baseline to week 12 in 6-min walking distance (6MWD) (MD 39). Riociguat increased the mean 6-minute walking distance by 39 meters from baseline to week 12 compared to 0 meters for placebo in patients with persistent or recurrent pulmonary arterial hypertension after correction of congenital heart disease.
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