Status:
RECRUITING
LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF
Lead Sponsor:
Tenax Therapeutics, Inc.
Collaborating Sponsors:
Medpace, Inc.
Northwestern University
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
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).
Detailed Description
This is a Phase 3, double-blind, randomized, placebo-controlled study of oral levosimendan in patients with PH-HFpEF. There will be a Screening Period of up to 30 days. Subjects will provide written i...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
January 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT05983250
Start Date
January 10 2024
End Date
October 1 2028
Last Update
December 18 2025
Active Locations (47)
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1
Tenax Investigational Site
Tucson, Arizona, United States, 85721
2
Tenax Investigational Site
La Jolla, California, United States, 92037
3
Tenax Investigational Site
Los Angeles, California, United States, 90033
4
Tenax Investigational Site
Los Angeles, California, United States, 90048