Why the study?
The optimal dose of Fasudil in congenital heart disease accompanied with severe pulmonary hypertension remains controversial.
Does intravenous Fasudil 60 mg improve hemodynamics more than 30 mg in adult patients with congenital heart disease and severe pulmonary arterial hypertension?
Does intravenous Fasudil 60 mg improve hemodynamics more than 30 mg in adult patients with congenital heart disease and severe pulmonary arterial hypertension?
Intravenous Fasudil at 60 mg provides greater acute hemodynamic improvement than 30 mg in adult patients with congenital heart disease and severe pulmonary arterial hypertension, without serious adverse reactions.
Should not yet change Fasudil dosing in CHD-PAH; leaves open whether 60 mg improves clinical outcomes.
OBJECTIVE: The optimal dose of Fasudil is still controversial in congenital heart disease accompanied with severe pulmonary hypertension (CHD-PAH). This study aimed to compare acute hemodynamic changes after different doses of Fasudil in 60 consecutive adult patients with CHD-PAH. DESIGN: Prospective randomized controlled trial. SETTING: Tertiary cardiology center. PATIENTS: Adult patients with CHD-PAH. INTERVENTIONS: Patients were randomized to Fasudil 30 or 60 mg. OUTCOME MEASURES: The hemodynamic parameters were measured at baseline and after 30 minutes of Fasudil through right cardiac catheterization. Blood gas results were obtained from the pulmonary artery, right ventricle, right atrium, superior and inferior vena cava, and femoral artery. Pulmonary vascular resistance (PVR) and systemic arterial resistance (SVR) were calculated. RESULTS: The changes in systolic pulmonary artery pressure (sPAP) (-13.1% vs -9.3%, P < .05), diastolic PAP (dPAP) (-17.6% vs -14.5%, P < .05), mean PAP (mPAP) (-12.4% vs -8.5%, P < .05), and PVR (-35.8% vs -22.2%, P < .05) were more pronounced in the 60-mg group than in the 30-mg group. All patients had no obvious adverse reactions related to peripheral blood pressure. CONCLUSIONS: Fasudil could improve the hemodynamics of patients with CHD-PAH, especially with the 60-mg dose. There were no serious adverse reactions.
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Zhang et al. (2019) studied this question.
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