LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2
Start Date
3/3/2026
Completion Date
6/30/2029
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.
Detailed Description
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.
Eligibility Criteria
Age Range: 18 years to 85 years
Interventions
TNX-103
Placebo
Conditions
Locations
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Alexander City, Alabama 35010
United States
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Tamarac, Florida 33321
United States
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Mount Prospect, Illinois 60056
United States
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Peoria, Illinois 61636
United States
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New Orleans, Louisiana 70115-6969
United States
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West Monroe, Louisiana 71291
United States
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Ypsilanti, Michigan 48197
United States
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Reno, Nevada 89502
United States
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New York, New York 10032
United States
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Winston-Salem, North Carolina 27101
United States
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Allentown, Pennsylvania 18105
United States
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Wynnewood, Pennsylvania 19096-3450
United States
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Nashville, Tennessee 37205
United States
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Austin, Texas 78705
United States
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Dallas, Texas 75390
United States
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Houston, Texas 77002
United States
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Norfolk, Virginia 23507-1904
United States
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Marshfield, Wisconsin 54449
United States
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Buenos Aires, Buenos Aires F.D. 1280
Argentina
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Corrientes, Corrientes Province W3400AMZ
Argentina
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San Luis, San Luis Province D5702JRS
Argentina
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Braunau am Inn, 5280
Austria
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Graz, 8036
Austria
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Klagenfurt, 9020
Austria
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Sankt Pölten, 3100
Austria
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Vienna, 1100
Austria
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Salvador, Estado de Bahia 40170-130
Brazil
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Belo Horizonte, Minas Gerais 30220
Brazil
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Curitiba, Paraná 80215-901
Brazil
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Ribeirão Preto, São Paulo 14026-020
Brazil
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Pleven, 5800
Bulgaria
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Sofia, 1407
Bulgaria
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Sofia, 1431
Bulgaria
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Sofia, 1750
Bulgaria
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Ostrava, 72880
Czechia
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Prague, 10034
Czechia
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Prague, 15006
Czechia
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Le Kremlin-Bicêtre, 94270
France
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Montpellier, 34295
France
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Nantes, 44007
France
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Nice, 06001
France
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Pau, 64000
France
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Bad Bevensen, 29549
Germany
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Bad Nauheim, 61231
Germany
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Berlin, 12683
Germany
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Dresden, 01307
Germany
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Hamburg, 20251
Germany
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Jena, 07747
Germany
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Budapest, 1122
Hungary
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Budapest, 1134
Hungary
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Debrecen, 4032
Hungary
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Szeged, 6275
Hungary
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Acquaviva delle Fonti, 70021
Italy
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Messina, 98125
Italy
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Milan, 20132
Italy
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Milan, 20138
Italy
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Milan, 20149
Italy
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Pavia, 27100
Italy
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Pisa, 56126
Italy
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Roma, 00168
Italy
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Rozzano, 20089
Italy
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Poznan, 61848
Poland
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Wroclaw, 50556
Poland
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Wroclaw, 50891
Poland
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Cheongju-si, 28644
South Korea
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Gwangju, 61469
South Korea
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Incheon, 21565
South Korea
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Seoul, 03080
South Korea
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Seoul, 08308
South Korea
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Wŏnju, 26426
South Korea
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Barcelona, 08003
Spain
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Barcelona, 08035
Spain
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Barcelona, 08036
Spain
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Lugo, 27003
Spain
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Madrid, 28041
Spain
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Madrid, 28046
Spain
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Madrid, 28055
Spain
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Marbella, 29603
Spain
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Málaga, 29010
Spain
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Pamplona, 31008
Spain
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Salamanca, 37007
Spain
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Seville, 41009
Spain
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Toledo, 45007
Spain
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Valencia, 46010
Spain
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Valencia, 46020
Spain
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Kaohsiung City, 80756
Taiwan
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Kaohsiung City, 813414
Taiwan
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Taipei, 10449
Taiwan
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Taipei, 110
Taiwan
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Taoyuan, 33305
Taiwan
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Cambridge, CB233RE
United Kingdom
Tenax Investigational Site
Swindon, SN36BB
United Kingdom