LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF
ConditionPulmonary Hypertension
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorTenax Therapeutics, Inc.
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- TNX-103
- Placebo
Treatment groups
230 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov