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).
This is a Phase 3, double-blind, randomized, placebo-controlled study of oral levosimendan in patients with PH-HFpEF. There will be a Screening Period of up to 30 days. Subjects will provide written informed consent prior to completing any study procedures. Upon meeting all eligibility criteria, patients will continue to the 12-week randomized, double-blind treatment phase. Approximately 230 subjects will be randomized in a 1:1 ratio to receive an oral dose of levosimendan or placebo All randomized subjects will have the option to enter the 92-week OLE following the completion of all study events at Week 12.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
230
Change in Six-minute walk distance
Time frame: 12 weeks
KCCQ
Change in KCCQ
Time frame: 12 weeks
Clinical Worsening Events
Time frame: 12 weeks
Change in NT-proBNP
Decreases in NT-proBNP may indicate an improvement in symptoms
Time frame: 12 weeks
Change NYHA functional class
On a scale of I-IV. Lower scores may indicate improvement in symptoms
Time frame: 12 weeks
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Tenax Investigational Site
Tucson, Arizona, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Atlanta, Georgia, United States
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