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RECRUITINGPhase 3INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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) Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

TNX-103

Oral levosimendan

DRUG

Placebo

Matching placebo (oral)

Locations (20)

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