RecruitingPhase 3NCT07288398

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

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction

Sponsor

Tenax Therapeutics, Inc.

Enrollment

540 participants

Start Date

Mar 3, 2026

Study Type

INTERVENTIONAL

Conditions

Pulmonary Hypertension Associated With HFpEF

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

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing levosimendan — a drug that makes the heart pump more efficiently — in people with pulmonary hypertension caused by heart failure with preserved ejection fraction (PH-HFpEF), to see if it improves exercise capacity. **You may be eligible if...** - You are between 18 and 85 years old - You have been diagnosed with WHO Group 2 pulmonary hypertension related to heart failure with preserved ejection fraction (PH-HFpEF) - This diagnosis has been confirmed by a right heart catheterization procedure - You have NYHA Class II, III, or ambulatory Class IV symptoms (ranging from mild to severe limitation during activity) - You have had an echocardiogram and a 6-minute walk test as part of the assessment **You may NOT be eligible if...** - Your pulmonary hypertension belongs to WHO Groups 1, 3, 4, or 5 (other causes) - You have hypertrophic cardiomyopathy, restrictive cardiomyopathy, cardiac amyloidosis, or constrictive pericarditis - You have had a recent heart valve repair or replacement - You have other serious conditions that would prevent safe participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTNX-103

Oral levosimendan

DRUGPlacebo

Matching placebo (oral)

Locations(141)

Tenax Investigational Site

Alexander City, Alabama, United States

Tenax Investigational Site

Tucson, Arizona, United States

Tenax Investigational Site

Sacramento, California, United States

Tenax Investigational Site

San Francisco, California, United States

Tenax Investigational Site

Stanford, California, United States

Tenax Investigational Site

Torrance, California, United States

Tenax Investigational Site

Athens, Georgia, United States

Tenax Investigational Site

Atlanta, Georgia, United States

Tenax Investigational Site

Chicago, Illinois, United States

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Chicago, Illinois, United States

Tenax Investigational Site

Mount Prospect, Illinois, United States

Tenax Investigational Site

Peoria, Illinois, United States

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Indianapolis, Indiana, United States

Tenax Investigational Site

New Orleans, Louisiana, United States

Tenax Investigational Site

West Monroe, Louisiana, United States

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Boston, Massachusetts, United States

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Ann Arbor, Michigan, United States

Tenax Investigational Site

Ypsilanti, Michigan, United States

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Minneapolis, Minnesota, United States

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Rochester, Minnesota, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Reno, Nevada, United States

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New York, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Durham, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Allentown, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Wynnewood, Pennsylvania, United States

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Charleston, South Carolina, 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

Tenax Investigational Site

El Paso, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Charlottesville, Virginia, United States

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Norfolk, Virginia, United States

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Seattle, Washington, United States

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Madison, Wisconsin, United States

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Marshfield, Wisconsin, United States

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San Juan Bautista, Buenos Aires, Argentina

Tenax Investigational Site

Buenos Aires, Buenos Aires F.D., Argentina

Tenax Investigational Site

Buenos Aires, Argentina

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Buenos Aires, Argentina

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Corrientes, Argentina

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Córdoba, Argentina

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Córdoba, Argentina

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San Luis, Argentina

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Santa Fe, Argentina

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Vienna, State of Vienna, Austria

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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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Goiânia, Goiás, Brazil

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Belo Horizonte, Minas Gerais, Brazil

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Curitiba, Paraná, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Ribeirão Preto, São Paulo, Brazil

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Burgas, Bulgaria

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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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Sofia, Bulgaria

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Ostrava, Czechia

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Prague, Czechia

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Prague, Czechia

Tenax Investigational Site

Le Kremlin-Bicêtre, France

Tenax Investigational Site

Montpellier, France

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Nantes, France

Tenax Investigational Site

Nice, France

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Pau, France

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Poitiers, 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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Mainz, 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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Bergamo, 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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Grodzisk Mazowiecki, Poland

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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

Tenax Investigational Site

Gwangju, South Korea

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Incheon, South Korea

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Seoul, South Korea

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Seoul, South Korea

Tenax Investigational Site

Wŏnju, South Korea

Tenax Investigational Site

Barcelona, Spain

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Barcelona, Spain

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Barcelona, Spain

Tenax Investigational Site

Lugo, Spain

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Madrid, Spain

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Madrid, Spain

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Madrid, Spain

Tenax Investigational Site

Marbella, Spain

Tenax Investigational Site

Málaga, Spain

Tenax Investigational Site

Pamplona, Spain

Tenax Investigational Site

Salamanca, Spain

Tenax Investigational Site

Seville, Spain

Tenax Investigational Site

Toledo, Spain

Tenax Investigational Site

Valencia, Spain

Tenax Investigational Site

Valencia, Spain

Tenax Investigational Site

Kaohsiung City, Taiwan

Tenax Investigational Site

Kaohsiung City, Taiwan

Tenax Investigational Site

Tainan, Taiwan

Tenax Investigational Site

Taipei, Taiwan

Tenax Investigational Site

Taipei, Taiwan

Tenax Investigational Site

Taoyuan, Taiwan

Tenax Investigational Site

Cambridge, United Kingdom

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Glasgow, United Kingdom

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London, United Kingdom

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London, United Kingdom

Tenax Investigational Site

Sheffield, United Kingdom

Tenax Investigational Site

Swindon, United Kingdom

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NCT07288398

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