LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2

Last updated: December 15, 2025
Sponsor: Tenax Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Hyponatremia

Chest Pain

Heart Failure

Treatment

TNX-103

Placebo

Clinical Study ID

NCT07288398
TNX-103-07
2025-522475-28-00
  • Ages 18-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Men or women, ≥18 to 85 years of age

  2. NYHA Class II or III or ambulatory NYHA Class IV symptoms

  3. A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifyinghemodynamics verified by right heart catheterization (RHC)

  4. A qualifying baseline RHC

  5. A qualifying echocardiogram

  6. A qualifying 6-MWD

  7. A 48-hour ambulatory cardiac rhythm monitor during the Screening Period

  8. Requirements related to child bearing potential, contraception, and egg/spermdonation)

Exclusion

Exclusion Criteria:

  1. A diagnosis of PH WHO Groups 1, 3, 4, or 5

  2. Echocardiographic evidence for hypertrophic cardiomyopathy, restrictivecardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrativecardiomyopathy

  3. Structural heart repair or replacement of the aortic valve or mitral valve (surgicalor percutaneous) OR, planned valve intervention OR, the presence of significantvalve disease

  4. A diagnosis of pre-existing lung disease

  5. History of severe allergic or anaphylactic reaction or hypersensitivity to theexcipients in the investigational product

  6. Major surgery within 60 days

  7. Prior heart, lung, or heart-lung transplants or life expectancy of <12 months

  8. History of clinically significant other diseases that may limit or complicateparticipation in the study

Study Design

Total Participants: 540
Treatment Group(s): 2
Primary Treatment: TNX-103
Phase: 3
Study Start date:
December 01, 2025
Estimated Completion Date:
June 30, 2029

Study 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.

Connect with a study center

  • Tenax Investigational Site

    Buenos Aires 3435910, Buenos Aires F.D. 3433955 1280
    Argentina

    Site Not Available

  • Tenax Investigational Site

    Corrientes 3435217, Corrientes Province 3435214 W3400AMZ
    Argentina

    Site Not Available

  • Tenax Investigational Site

    San Luis 3837056, San Luis Province 3837029 D5702JRS
    Argentina

    Site Not Available

  • Tenax Investigational Site

    Braunau am Inn 2781520, 5280
    Austria

    Site Not Available

  • Tenax Investigational Site

    Graz 2778067, 8036
    Austria

    Site Not Available

  • Tenax Investigational Site

    Klagenfurt 2774326, 9020
    Austria

    Site Not Available

  • Tenax Investigational Site

    Sankt Pölten 2766429, 3100
    Austria

    Site Not Available

  • Tenax Investigational Site

    Vienna 2761369, 1100
    Austria

    Site Not Available

  • Tenax Investigational Site

    Salvador 3450554, Estado de Bahia 3471168 40170-130
    Brazil

    Site Not Available

  • Tenax Investigational Site

    Belo Horizonte 3470127, Minas Gerais 3457153 30220
    Brazil

    Site Not Available

  • Tenax Investigational Site

    Curitiba 3464975, Paraná 3455077 80215-901
    Brazil

    Site Not Available

  • Tenax Investigational Site

    Ribeirão Preto 3451328, São Paulo 3448433 14026-020
    Brazil

    Site Not Available

  • Tenax Investigational Site

    Pleven 728203, 5800
    Bulgaria

    Site Not Available

  • Tenax Investigational Site

    Sofia 727011, 1407
    Bulgaria

    Site Not Available

  • Tenax Investigational Site

    Ostrava 3068799, 72880
    Czechia

    Site Not Available

  • Tenax Investigational Site

    Prague 3067696, 15006
    Czechia

    Site Not Available

  • Tenax Investigational Site

    Le Kremlin-Bicêtre 3003737, 94270
    France

    Site Not Available

  • Tenax Investigational Site

    Montpellier 2992166, 34295
    France

    Site Not Available

  • Tenax Investigational Site

    Nantes 2990969, 44007
    France

    Site Not Available

  • Tenax Investigational Site

    Nice 2990440, 06001
    France

    Site Not Available

  • Tenax Investigational Site

    Pau 2988358, 64000
    France

    Site Not Available

  • Tenax Investigational Site

    Bad Bevensen 2949511, 29549
    Germany

    Site Not Available

  • Tenax Investigational Site

    Bad Nauheim 2953395, 61231
    Germany

    Site Not Available

  • Tenax Investigational Site

    Berlin 2950159, 12683
    Germany

    Site Not Available

  • Tenax Investigational Site

    Dresden 2935022, 01307
    Germany

    Site Not Available

  • Tenax Investigational Site

    Hamburg 2911298, 20251
    Germany

    Site Not Available

  • Tenax Investigational Site

    Jena 2895044, 07747
    Germany

    Site Not Available

  • Tenax Investigational Site

    Budapest 3054643, 1134
    Hungary

    Site Not Available

  • Tenax Investigational Site

    Debrecen 721472, 4032
    Hungary

    Site Not Available

  • Tenax Investigational Site

    Szeged 715429, 6275
    Hungary

    Site Not Available

  • Tenax Investigational Site

    Acquaviva delle Fonti 3183494, 70021
    Italy

    Site Not Available

  • Tenax Investigational Site

    Messina 2524170, 98125
    Italy

    Site Not Available

  • Tenax Investigational Site

    Milan 6951411, 20132
    Italy

    Site Not Available

  • Tenax Investigational Site

    Pavia 3171366, 27100
    Italy

    Site Not Available

  • Tenax Investigational Site

    Pisa 3170647, 56126
    Italy

    Site Not Available

  • Tenax Investigational Site

    Roma 8957247, 00168
    Italy

    Site Not Available

  • Tenax Investigational Site

    Rozzano 3168837, 20089
    Italy

    Site Not Available

  • Tenax Investigational Site

    Poznan 3088171, 61848
    Poland

    Site Not Available

  • Tenax Investigational Site

    Wroclaw 3081368, 50556
    Poland

    Site Not Available

  • Tenax Investigational Site

    Cheongju-si 1845604, 28644
    South Korea

    Site Not Available

  • Tenax Investigational Site

    Gwangju 1841811, 61469
    South Korea

    Site Not Available

  • Tenax Investigational Site

    Incheon 1843564, 21565
    South Korea

    Site Not Available

  • Tenax Investigational Site

    Seoul 1835848, 03080
    South Korea

    Site Not Available

  • Tenax Investigational Site

    Wŏnju 1833105, 26426
    South Korea

    Site Not Available

  • Tenax Investigational Site

    Barcelona 3128760, 08035
    Spain

    Site Not Available

  • Tenax Investigational Site

    Lugo 3117814, 27003
    Spain

    Site Not Available

  • Tenax Investigational Site

    Madrid 3117735, 28046
    Spain

    Site Not Available

  • Tenax Investigational Site

    Marbella 2514169, 29603
    Spain

    Site Not Available

  • Tenax Investigational Site

    Málaga 2514256, 29010
    Spain

    Site Not Available

  • Tenax Investigational Site

    Pamplona 3114472, 31008
    Spain

    Site Not Available

  • Tenax Investigational Site

    Salamanca 3111108, 37007
    Spain

    Site Not Available

  • Tenax Investigational Site

    Seville 2510911, 41009
    Spain

    Site Not Available

  • Tenax Investigational Site

    Toledo 2510409, 45007
    Spain

    Site Not Available

  • Tenax Investigational Site

    Valencia 2509954, 46020
    Spain

    Site Not Available

  • Tenax Investigational Site

    Kaohsiung City 1673820, 813414
    Taiwan

    Site Not Available

  • Tenax Investigational Site

    Taipei 1668341, 10449
    Taiwan

    Site Not Available

  • Tenax Investigational Site

    Taoyuan District 1667905, 33305
    Taiwan

    Site Not Available

  • Tenax Investigational Site

    Cambridge 2653941, CB233RE
    United Kingdom

    Site Not Available

  • Tenax Investigational Site

    Swindon 2636389, SN36BB
    United Kingdom

    Site Not Available

  • Tenax Investigational Site

    Alexander City 4829843, Alabama 4829764 35010
    United States

    Site Not Available

  • Tenax Investigational Site

    Tamarac 4174738, Florida 4155751 33321
    United States

    Site Not Available

  • Tenax Investigational Site

    Mount Prospect 4903024, Illinois 4896861 60056
    United States

    Site Not Available

  • Tenax Investigational Site

    Peoria 4905687, Illinois 4896861 61636
    United States

    Site Not Available

  • Tenax Investigational Site

    New Orleans 4335045, Louisiana 4331987 70115-6969
    United States

    Site Not Available

  • Tenax Investigational Site

    West Monroe 4345850, Louisiana 4331987 71291
    United States

    Site Not Available

  • Tenax Investigational Site

    Ypsilanti 5015688, Michigan 5001836 48197
    United States

    Site Not Available

  • Tenax Investigational Site

    Reno 5511077, Nevada 5509151 89502
    United States

    Site Not Available

  • Tenax Investigational Site

    New York 5128581, New York 5128638 10032
    United States

    Site Not Available

  • Tenax Investigational Site

    Winston-Salem 4499612, North Carolina 4482348 27101
    United States

    Site Not Available

  • Tenax Investigational Site

    Allentown 5178127, Pennsylvania 6254927 18105
    United States

    Site Not Available

  • Tenax Investigational Site

    Wynnewood 5220230, Pennsylvania 6254927 19096-3450
    United States

    Site Not Available

  • Tenax Investigational Site

    Nashville 4644585, Tennessee 4662168 37205
    United States

    Site Not Available

  • Tenax Investigational Site

    Austin 4671654, Texas 4736286 78705
    United States

    Site Not Available

  • Tenax Investigational Site

    Houston 4699066, Texas 4736286 77002
    United States

    Active - Recruiting

  • Tenax Investigational Site

    Norfolk 4776222, Virginia 6254928 23507-1904
    United States

    Site Not Available

  • Tenax Investigational Site

    Marshfield 5261969, Wisconsin 5279468 54449
    United States

    Site Not Available

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