A Phase 3 Study of Fenfluramine Hydrochloride in Rett Syndrome

Exclusion criteria

• ✕. Greater than trace aortic valve regurgitation.
• ✕. Greater than mild mitral valve regurgitation.
• ✕. Possible signs of pulmonary arterial hypertension (PAH) with abnormal pulmonary artery systolic pressure (PASP) or PASP ≥35 mmHg.
• ✕. Evidence of left ventricular dysfunction (systolic or diastolic).
• ✕. Clinically significant structural cardiac abnormality, including but not limited to mitral valve prolapse, atrial or ventricular septal defects, or patent ductus arteriosus with reversal of shunt (right to left shunt). Note: Patent foramen ovale without a reversal of shunt or a bicuspid aortic valve is not considered exclusionary