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NCT07288398PHASE3Recruiting

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

Tenax Therapeutics, Inc.

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

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 qualifying hemodynamics 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/sperm donation) Exclusion Criteria: 1. A diagnosis of PH WHO Groups 1, 3, 4, or 5 2. Echocardiographic evidence for hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrative cardiomyopathy 3. Structural heart repair or replacement of the aortic valve or mitral valve (surgical or percutaneous) OR, planned valve intervention OR, the presence of significant valve disease 4. A diagnosis of pre-existing lung disease 5. History of severe allergic or anaphylactic reaction or hypersensitivity to the excipients 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 complicate participation in the study

Interventions

DRUG

TNX-103

DRUG

Placebo

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Conditions

Pulmonary Hypertension Associated With HFpEF

Locations

Tenax Investigational Site

Alexander City, Alabama 35010

United States

Tenax Investigational Site

Tamarac, Florida 33321

United States

Tenax Investigational Site

Mount Prospect, Illinois 60056

United States

Tenax Investigational Site

Peoria, Illinois 61636

United States

Tenax Investigational Site

New Orleans, Louisiana 70115-6969

United States

Tenax Investigational Site

West Monroe, Louisiana 71291

United States

Tenax Investigational Site

Ypsilanti, Michigan 48197

United States

Tenax Investigational Site

Reno, Nevada 89502

United States

Tenax Investigational Site

New York, New York 10032

United States

Tenax Investigational Site

Winston-Salem, North Carolina 27101

United States

Tenax Investigational Site

Allentown, Pennsylvania 18105

United States

Tenax Investigational Site

Wynnewood, Pennsylvania 19096-3450

United States

Tenax Investigational Site

Nashville, Tennessee 37205

United States

Tenax Investigational Site

Austin, Texas 78705

United States

Tenax Investigational Site

Dallas, Texas 75390

United States

Tenax Investigational Site

Houston, Texas 77002

United States

Tenax Investigational Site

Norfolk, Virginia 23507-1904

United States

Tenax Investigational Site

Marshfield, Wisconsin 54449

United States

Tenax Investigational Site

Buenos Aires, Buenos Aires F.D. 1280

Argentina

Tenax Investigational Site

Corrientes, Corrientes Province W3400AMZ

Argentina

Tenax Investigational Site

San Luis, San Luis Province D5702JRS

Argentina

Tenax Investigational Site

Braunau am Inn, 5280

Austria

Tenax Investigational Site

Graz, 8036

Austria

Tenax Investigational Site

Klagenfurt, 9020

Austria

Tenax Investigational Site

Sankt Pölten, 3100

Austria

Tenax Investigational Site

Vienna, 1100

Austria

Tenax Investigational Site

Salvador, Estado de Bahia 40170-130

Brazil

Tenax Investigational Site

Belo Horizonte, Minas Gerais 30220

Brazil

Tenax Investigational Site

Curitiba, Paraná 80215-901

Brazil

Tenax Investigational Site

Ribeirão Preto, São Paulo 14026-020

Brazil

Tenax Investigational Site

Pleven, 5800

Bulgaria

Tenax Investigational Site

Sofia, 1407

Bulgaria

Tenax Investigational Site

Sofia, 1431

Bulgaria

Tenax Investigational Site

Sofia, 1750

Bulgaria

Tenax Investigational Site

Ostrava, 72880

Czechia

Tenax Investigational Site

Prague, 10034

Czechia

Tenax Investigational Site

Prague, 15006

Czechia

Tenax Investigational Site

Le Kremlin-Bicêtre, 94270

France

Tenax Investigational Site

Montpellier, 34295

France

Tenax Investigational Site

Nantes, 44007

France

Tenax Investigational Site

Nice, 06001

France

Tenax Investigational Site

Pau, 64000

France

Tenax Investigational Site

Bad Bevensen, 29549

Germany

Tenax Investigational Site

Bad Nauheim, 61231

Germany

Tenax Investigational Site

Berlin, 12683

Germany

Tenax Investigational Site

Dresden, 01307

Germany

Tenax Investigational Site

Hamburg, 20251

Germany

Tenax Investigational Site

Jena, 07747

Germany

Tenax Investigational Site

Budapest, 1122

Hungary

Tenax Investigational Site

Budapest, 1134

Hungary

Tenax Investigational Site

Debrecen, 4032

Hungary

Tenax Investigational Site

Szeged, 6275

Hungary

Tenax Investigational Site

Acquaviva delle Fonti, 70021

Italy

Tenax Investigational Site

Messina, 98125

Italy

Tenax Investigational Site

Milan, 20132

Italy

Tenax Investigational Site

Milan, 20138

Italy

Tenax Investigational Site

Milan, 20149

Italy

Tenax Investigational Site

Pavia, 27100

Italy

Tenax Investigational Site

Pisa, 56126

Italy

Tenax Investigational Site

Roma, 00168

Italy

Tenax Investigational Site

Rozzano, 20089

Italy

Tenax Investigational Site

Poznan, 61848

Poland

Tenax Investigational Site

Wroclaw, 50556

Poland

Tenax Investigational Site

Wroclaw, 50891

Poland

Tenax Investigational Site

Cheongju-si, 28644

South Korea

Tenax Investigational Site

Gwangju, 61469

South Korea

Tenax Investigational Site

Incheon, 21565

South Korea

Tenax Investigational Site

Seoul, 03080

South Korea

Tenax Investigational Site

Seoul, 08308

South Korea

Tenax Investigational Site

Wŏnju, 26426

South Korea

Tenax Investigational Site

Barcelona, 08003

Spain

Tenax Investigational Site

Barcelona, 08035

Spain

Tenax Investigational Site

Barcelona, 08036

Spain

Tenax Investigational Site

Lugo, 27003

Spain

Tenax Investigational Site

Madrid, 28041

Spain

Tenax Investigational Site

Madrid, 28046

Spain

Tenax Investigational Site

Madrid, 28055

Spain

Tenax Investigational Site

Marbella, 29603

Spain

Tenax Investigational Site

Málaga, 29010

Spain

Tenax Investigational Site

Pamplona, 31008

Spain

Tenax Investigational Site

Salamanca, 37007

Spain

Tenax Investigational Site

Seville, 41009

Spain

Tenax Investigational Site

Toledo, 45007

Spain

Tenax Investigational Site

Valencia, 46010

Spain

Tenax Investigational Site

Valencia, 46020

Spain

Tenax Investigational Site

Kaohsiung City, 80756

Taiwan

Tenax Investigational Site

Kaohsiung City, 813414

Taiwan

Tenax Investigational Site

Taipei, 10449

Taiwan

Tenax Investigational Site

Taipei, 110

Taiwan

Tenax Investigational Site

Taoyuan, 33305

Taiwan

Tenax Investigational Site

Cambridge, CB233RE

United Kingdom

Tenax Investigational Site

Swindon, SN36BB

United Kingdom