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
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Tucson, Arizona 85724
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Sacramento, California 95816
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San Francisco, California 94143
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Stanford, California 94305-5208
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Torrance, California 90502
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Athens, Georgia 30606
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Atlanta, Georgia 30322
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Chicago, Illinois 60611-4494
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Chicago, Illinois 60637
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Mount Prospect, Illinois 60056
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Peoria, Illinois 61636
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Indianapolis, Indiana 46260
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New Orleans, Louisiana 70115-6969
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West Monroe, Louisiana 71291
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Boston, Massachusetts 02114-2621
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Ann Arbor, Michigan 48109
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Ypsilanti, Michigan 48197
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Minneapolis, Minnesota 55455
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Rochester, Minnesota 55905
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Kansas City, Missouri 64111
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St Louis, Missouri 63136
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Omaha, Nebraska 68198
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Reno, Nevada 89502
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New York, New York 10021
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New York, New York 10032
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Rochester, New York 14617
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Durham, North Carolina 27710
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Winston-Salem, North Carolina 27101
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Cleveland, Ohio 44195-0001
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Columbus, Ohio 43210
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Allentown, Pennsylvania 18105
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Pittsburgh, Pennsylvania 15212
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Wynnewood, Pennsylvania 19096-3450
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Charleston, South Carolina 29425
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Nashville, Tennessee 37205
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Austin, Texas 78705
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Dallas, Texas 75390
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El Paso, Texas 79905-2707
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Houston, Texas 77002
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Houston, Texas 77030-2342
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Charlottesville, Virginia 22908
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Norfolk, Virginia 23507-1904
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Seattle, Washington 98122
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Madison, Wisconsin 53706
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Marshfield, Wisconsin 54449
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San Juan Bautista, Buenos Aires 1888
Argentina
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Buenos Aires, Buenos Aires F.D. 1280
Argentina
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Buenos Aires, C1180AAX
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Buenos Aires, C1428ART
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Corrientes, W3400AMZ
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Córdoba, 5000
Argentina
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Córdoba, X5016KET
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San Luis, D5702JRS
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Santa Fe, S2002KDS
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Vienna, State of Vienna 1090
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Braunau am Inn, 5280
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Graz, 8036
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Klagenfurt, 9020
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Sankt Pölten, 3100
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Vienna, 1100
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Salvador, Estado de Bahia 40170-130
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Goiânia, Goiás 74605
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Belo Horizonte, Minas Gerais 30220
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Curitiba, Paraná 80215-901
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Porto Alegre, Rio Grande do Sul 90020-090
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Porto Alegre, Rio Grande do Sul 90035-903
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Ribeirão Preto, São Paulo 14026-020
Brazil
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Burgas, 8000
Bulgaria
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Pleven, 5800
Bulgaria
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Sofia, 1309
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Sofia, 1407
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Sofia, 1431
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Sofia, 1750
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Ostrava, 72880
Czechia
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Prague, 10034
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Prague, 15006
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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
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Poitiers, 86000
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Bad Bevensen, 29549
Germany
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Bad Nauheim, 61231
Germany
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Berlin, 12683
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Dresden, 01307
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Hamburg, 20251
Germany
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Jena, 07747
Germany
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Mainz, 55131
Germany
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Budapest, 1122
Hungary
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Budapest, 1134
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Debrecen, 4032
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Szeged, 6275
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Acquaviva delle Fonti, 70021
Italy
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Bergamo, 24127
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Messina, 98125
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Milan, 20132
Italy
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Milan, 20138
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Milan, 20149
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Pavia, 27100
Italy
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Pisa, 56126
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Roma, 00168
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Rozzano, 20089
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Grodzisk Mazowiecki, 05-825
Poland
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Poznan, 61848
Poland
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Wroclaw, 50556
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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
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Seoul, 08308
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Wŏnju, 26426
South Korea
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Barcelona, 08003
Spain
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Barcelona, 08035
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Barcelona, 08036
Spain
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Lugo, 27003
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Madrid, 28041
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Madrid, 28046
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Madrid, 28055
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Marbella, 29603
Spain
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Málaga, 29010
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Pamplona, 31008
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Salamanca, 37007
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Seville, 41009
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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
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Kaohsiung City, 813414
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Tainan, 71004
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Taipei, 10449
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Taipei, 110
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Taoyuan, 33305
Taiwan
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Cambridge, CB233RE
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Glasgow, G81 4HS
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London, SW3 6NP
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London, W12 0HS
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Sheffield, S10 2JF
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Swindon, SN36BB
United Kingdom