RecruitingPhase 3NCT05983250
LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction (PH-HFpEF)
Sponsor
Tenax Therapeutics, Inc.
Enrollment
230 participants
Start Date
Jan 10, 2024
Study Type
INTERVENTIONAL
Conditions
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).
Eligibility
Min Age: 18 YearsMax Age: 85 Years
Inclusion Criteria8
- 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 Criteria8
- 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.
Interventions
DRUGTNX-103
oral levosimendan 1 mg
DRUGPlacebo
Placebo
Locations(44)
View Full Details on ClinicalTrials.gov
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NCT05983250
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