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.
Approximately 540 participants will be randomized in a 2:1 ratio to receive an oral dose of levosimendan or placebo. Participants will be eligible for an open label extension (OLE) of 52-weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
540
6-Minute Walk Distance (6MWD)
Change in 6-minute walk distance
Time frame: 26 weeks
KCCQ
Change in KCCQ Total Symptom Score
Time frame: 26 weeks
Clinical Worsening Events
Number of Clinical Worsening Events
Time frame: 26 weeks
Clinical Worsening Event
Time to first occurrence of a Clinical Worsening Event
Time frame: 26 weeks
NYHA Functional Class
Change in NYHA Functional Class
Time frame: 26 weeks
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Tenax Investigational Site
Alexander City, Alabama, United States
NOT_YET_RECRUITINGTenax Investigational Site
Tamarac, Florida, United States
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Mount Prospect, Illinois, United States
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Peoria, Illinois, United States
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New Orleans, Louisiana, United States
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West Monroe, Louisiana, United States
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Ypsilanti, Michigan, United States
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Reno, Nevada, United States
NOT_YET_RECRUITINGTenax Investigational Site
New York, New York, United States
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Winston-Salem, North Carolina, United States
NOT_YET_RECRUITING...and 81 more locations