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LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2
Sponsor: Tenax Therapeutics, Inc.
Summary
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.
Official title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
540
Start Date
2026-03-03
Completion Date
2029-06-30
Last Updated
2026-03-16
Healthy Volunteers
No
Interventions
TNX-103
Oral levosimendan
Placebo
Matching placebo (oral)
Locations (92)
Tenax Investigational Site
Alexander City, Alabama, United States
Tenax 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
Tenax Investigational Site
Reno, Nevada, United States
Tenax Investigational Site
New York, New York, United States
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Winston-Salem, North Carolina, United States
Tenax Investigational Site
Allentown, Pennsylvania, United States
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Wynnewood, Pennsylvania, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Norfolk, Virginia, United States
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Marshfield, Wisconsin, United States
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Buenos Aires, Buenos Aires F.D., Argentina
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Corrientes, Corrientes Province, Argentina
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San Luis, San Luis Province, Argentina
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Braunau am Inn, Austria
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Graz, Austria
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Klagenfurt, Austria
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Sankt Pölten, Austria
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Vienna, Austria
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Salvador, Estado de Bahia, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Curitiba, Paraná, Brazil
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Ribeirão Preto, São Paulo, Brazil
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Pleven, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Ostrava, Czechia
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Prague, Czechia
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Prague, Czechia
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Le Kremlin-Bicêtre, France
Tenax Investigational Site
Montpellier, France
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Nantes, France
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Nice, France
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Pau, France
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Bad Bevensen, Germany
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Bad Nauheim, Germany
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Berlin, Germany
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Dresden, Germany
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Hamburg, Germany
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Jena, Germany
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Budapest, Hungary
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Budapest, Hungary
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Debrecen, Hungary
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Szeged, Hungary
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Acquaviva delle Fonti, Italy
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Messina, Italy
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Milan, Italy
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Milan, Italy
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Milan, Italy
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Pavia, Italy
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Pisa, Italy
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Roma, Italy
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Rozzano, Italy
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Poznan, Poland
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Wroclaw, Poland
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Wroclaw, Poland
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Cheongju-si, South Korea
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Gwangju, South Korea
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Incheon, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Wŏnju, South Korea
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Barcelona, Spain
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Barcelona, Spain
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Barcelona, Spain
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Lugo, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Marbella, Spain
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Málaga, Spain
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Pamplona, Spain
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Salamanca, Spain
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Seville, Spain
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Toledo, Spain
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Valencia, Spain
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Valencia, Spain
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Kaohsiung City, Taiwan
Tenax Investigational Site
Kaohsiung City, Taiwan
Tenax Investigational Site
Taipei, Taiwan
Tenax Investigational Site
Taipei, Taiwan
Tenax Investigational Site
Taoyuan District, Taiwan
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Cambridge, United Kingdom
Tenax Investigational Site
Swindon, United Kingdom