Gender
All
Age Group
18 Years to 85 Years
Accepting Healthy Volunteers
No
Inclusion Criteria:
1. Men or women, greater than or equal to18 to 85 years of age.
2. NYHA Class II or III or NYHA class IV symptoms.
3. A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying
hemodynamics
4. Qualifying Baseline RHC.
5. Qualifying echocardiogram
6. Qualifying 6-MWD
7. A 48-hour ambulatory cardiac rhythm monitor during the Screening Period.
8. Requirements related to child bearing potential, contraception, and egg/sperm
donation
Exclusion Criteria:
1. A diagnosis of PH WHO Groups 1, 3, 4, or 5.
2. Echocardiographic evidence for hypertrophic cardiomyopathy, restrictive
cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrative
cardiomyopathy
3. 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
4. A diagnosis of pre-existing lung disease
5. History of severe allergic or anaphylactic reaction or hypersensitivity to the
excipients in the investigational product.
6. Major surgery within 60 days.
7. Prior heart, lung, or heart-lung transplants or life expectancy of <12 months
8. History of clinically significant other diseases that may limit or complicate
participation in the study.