LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF

What this study is about

This study will evaluate the efficacy of TNX-103 (oral levosimendan) compared with placebo in subjects with PH-HFpEF as measured by the change in 6-Minute Walk Distance (6 MWD; Day 1 to Week 12).

Who can join (things the study team will check)

✅ You may be able to join if…

• Men or women, greater than or equal to18 to 85 years of age.
• NYHA Class II or III or NYHA class IV symptoms.
• A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics
• Qualifying Baseline RHC.
• Qualifying echocardiogram
• 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

🚫 You may not be able to join if…

• 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.

Where this trial is running

• Tenax Investigational Site, Tucson, Arizona, United States
• Tenax Investigational Site, La Jolla, California, United States
• Tenax Investigational Site, Los Angeles, California, United States
• Tenax Investigational Site, Los Angeles, California, United States
• Tenax Investigational Site, Sacramento, California, United States
• Tenax Investigational Site, San Francisco, California, United States
• Tenax Investigational Site, Torrance, California, United States
• Tenax Investigational Site, Jacksonville, Florida, United States
• Tenax Investigational Site, Winter Haven, Florida, United States
• Tenax Investigational Site, Atlanta, Georgia, United States
• Tenax Investigational Site, Chicago, Illinois, United States
• Tenax Investigational Site, Chicago, Illinois, United States

+ 32 more sites.

Who to contact

Kevin Crawford · 19198552145 · k.crawford@tenaxthera.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05983250.