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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
TNX-103
Drugoral levosimendan 1 mg
Placebo
DrugPlacebo
Treatment groups
230 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: TNX-103Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Six-minute walk distance
Time frame
12 weeksSecondary outcomes
1
KCCQ
Change in KCCQ
Time frame
12 weeks2
Clinical Worsening Events
Time frame
12 weeks3
Change in NT-proBNP
Decreases in NT-proBNP may indicate an improvement in symptoms
Time frame
12 weeks4
Change NYHA functional class
On a scale of I-IV. Lower scores may indicate improvement in symptoms
Time frame
12 weeksSponsors and contacts
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Source ClinicalTrials.gov