A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients with Heart Failure with Left Ventricular Ejection fraction

To evaluate the efficacy of levosimendan (TNX-103) compared with placebo in patients with pulmonary hypertension with heart failure with preserved left ventricular ejection fraction (PH-HFpEF) as measured by the change in 6-Minute Walk Distance (6-MWD) (Day 1 to Week 26).

• Adults 18-85 years of age
• A diagnosis of WHO Group 2 Pulmonary Hypertension associated with Heart Failure with Preserved Ejection Fraction (PH-HFpEF)
• No Pulmonary Thromboembolism or Pulmonary Hypertension WHO Groups 1,3,4, or 5
• No walking activity that is limited by arthritis and rheumatologic disorders, muscular disorders, neurologic disorders, symptomatic peripheral vascular disease, or generalized weakness

• Right Heart Catheterization (RHC)
• Completing questionnaires
• Echocardiograms (ECG) and arrhythmia monitoring
• 6-minute walk test
• Urine and blood tests
• In-clinic visits as well as virtual visits completed via phone