LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorTenax Therapeutics, Inc.
About this trial
The purpose of this study is to assess the efficacy and safety of the study drug, levosimendan (given orally), compared to placebo in participants with pulmonary hypertension with heart failure with preserved left ventricular ejection fraction (PH-HFpEF) as measured by the change in 6-Minute Walk Distance.
Eligibility criteria
Qualifiers
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
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
540 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov