LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2

Approximately 540 participants will be randomized in a 2:1 ratio to receive an oral dose of levosimendan or placebo. Participants will be eligible for an open label extension (OLE) of 52-weeks.

Inclusion criteria

• Men or women, ≥18 to 85 years of age
• NYHA Class II or III or ambulatory NYHA Class IV symptoms
• A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics verified by right heart catheterization (RHC)
• A qualifying baseline RHC
• A qualifying echocardiogram
• A qualifying 6-MWD
• A 48-hour ambulatory cardiac rhythm monitor during the Screening Period
• Requirements related to child bearing potential, contraception, and egg/sperm donation)

Exclusion criteria

• A diagnosis of PH WHO Groups 1, 3, 4, or 5
• Echocardiographic evidence for hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrative cardiomyopathy
• Structural heart repair or replacement of the aortic valve or mitral valve (surgical or percutaneous) OR, planned valve intervention OR, the presence of significant valve disease
• A diagnosis of pre-existing lung disease
• History of severe allergic or anaphylactic reaction or hypersensitivity to the excipients in the investigational product
• Major surgery within 60 days
• Prior heart, lung, or heart-lung transplants or life expectancy of <12 months
• History of clinically significant other diseases that may limit or complicate participation in the study