Heart and Vascular Care
The cardiologists and cardiovascular surgeons at Main Line Health work together to improve the detection and prevention of heart disease with the latest treatment options.
Clinical Trials
Clinical Trial Number: LEVEL-2
| Study ID: | LEVEL-2 |
|---|---|
| Phase | III |
| Physician Investigator(s) | |
| Study Locations |
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