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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGTNX-103

Oral levosimendan

DRUGPlacebo

Matching placebo (oral)

Locations(92)

Tenax Investigational Site

Alexander City, Alabama, United States

Tenax Investigational Site

Tamarac, Florida, United States

Tenax Investigational Site

Mount Prospect, Illinois, United States

Tenax Investigational Site

Peoria, Illinois, United States

Tenax Investigational Site

New Orleans, Louisiana, United States

Tenax Investigational Site

West Monroe, Louisiana, United States

Tenax Investigational Site

Ypsilanti, Michigan, United States

Tenax Investigational Site

Reno, Nevada, United States

Tenax Investigational Site

New York, New York, United States

Tenax Investigational Site

Winston-Salem, North Carolina, United States

Tenax Investigational Site

Allentown, Pennsylvania, United States

Tenax Investigational Site

Wynnewood, Pennsylvania, United States

Tenax Investigational Site

Nashville, Tennessee, United States

Tenax Investigational Site

Austin, Texas, United States

Tenax Investigational Site

Dallas, Texas, United States

Tenax Investigational Site

Houston, Texas, United States

Tenax Investigational Site

Norfolk, Virginia, United States

Tenax Investigational Site

Marshfield, Wisconsin, United States

Tenax Investigational Site

Buenos Aires, Buenos Aires F.D., Argentina

Tenax Investigational Site

Corrientes, Corrientes Province, Argentina

Tenax Investigational Site

San Luis, San Luis Province, Argentina

Tenax Investigational Site

Braunau am Inn, Austria

Tenax Investigational Site

Graz, Austria

Tenax Investigational Site

Klagenfurt, Austria

Tenax Investigational Site

Sankt Pölten, Austria

Tenax Investigational Site

Vienna, Austria

Tenax Investigational Site

Salvador, Estado de Bahia, Brazil

Tenax Investigational Site

Belo Horizonte, Minas Gerais, Brazil

Tenax Investigational Site

Curitiba, Paraná, Brazil

Tenax Investigational Site

Ribeirão Preto, São Paulo, Brazil

Tenax Investigational Site

Pleven, Bulgaria

Tenax Investigational Site

Sofia, Bulgaria

Tenax Investigational Site

Sofia, Bulgaria

Tenax Investigational Site

Sofia, Bulgaria

Tenax Investigational Site

Ostrava, Czechia

Tenax Investigational Site

Prague, Czechia

Tenax Investigational Site

Prague, Czechia

Tenax Investigational Site

Le Kremlin-Bicêtre, France

Tenax Investigational Site

Montpellier, France

Tenax Investigational Site

Nantes, France

Tenax Investigational Site

Nice, France

Tenax Investigational Site

Pau, France

Tenax Investigational Site

Bad Bevensen, Germany

Tenax Investigational Site

Bad Nauheim, Germany

Tenax Investigational Site

Berlin, Germany

Tenax Investigational Site

Dresden, Germany

Tenax Investigational Site

Hamburg, Germany

Tenax Investigational Site

Jena, Germany

Tenax Investigational Site

Budapest, Hungary

Tenax Investigational Site

Budapest, Hungary

Tenax Investigational Site

Debrecen, Hungary

Tenax Investigational Site

Szeged, Hungary

Tenax Investigational Site

Acquaviva delle Fonti, Italy

Tenax Investigational Site

Messina, Italy

Tenax Investigational Site

Milan, Italy

Tenax Investigational Site

Milan, Italy

Tenax Investigational Site

Milan, Italy

Tenax Investigational Site

Pavia, Italy

Tenax Investigational Site

Pisa, Italy

Tenax Investigational Site

Roma, Italy

Tenax Investigational Site

Rozzano, Italy

Tenax Investigational Site

Poznan, Poland

Tenax Investigational Site

Wroclaw, Poland

Tenax Investigational Site

Wroclaw, Poland

Tenax Investigational Site

Cheongju-si, South Korea

Tenax Investigational Site

Gwangju, South Korea

Tenax Investigational Site

Incheon, South Korea

Tenax Investigational Site

Seoul, South Korea

Tenax Investigational Site

Seoul, South Korea

Tenax Investigational Site

Wŏnju, South Korea

Tenax Investigational Site

Barcelona, Spain

Tenax Investigational Site

Barcelona, Spain

Tenax Investigational Site

Barcelona, Spain

Tenax Investigational Site

Lugo, Spain

Tenax Investigational Site

Madrid, Spain

Tenax Investigational Site

Madrid, Spain

Tenax Investigational Site

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

Taipei, Taiwan

Tenax Investigational Site

Taipei, Taiwan

Tenax Investigational Site

Taoyuan, Taiwan

Tenax Investigational Site

Cambridge, United Kingdom

Tenax Investigational Site

Swindon, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07288398