RECRUITINGPhase 3INTERVENTIONAL
LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Levosimendan in Pulmonary Hypertension Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction (PH-HFpEF)
About This Trial
This study will evaluate the efficacy of TNX-103 (oral levosimendan) compared with placebo in subjects with PH-HFpEF as measured by the change in 6-Minute Walk Distance (6 MWD; Day 1 to Week 12).
Who May Be Eligible (Plain English)
Who May Qualify:
1. Men or women, greater than or equal to18 to 85 years of age.
2. NYHA Class II or III or NYHA class IV symptoms.
3. A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics
4. Qualifying Baseline RHC.
5. Qualifying echocardiogram
6. 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, greater than or equal to18 to 85 years of age.
2. NYHA Class II or III or NYHA class IV symptoms.
3. A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics
4. Qualifying Baseline RHC.
5. Qualifying echocardiogram
6. 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 1 mg
DRUG
Placebo
Placebo
Locations (20)
Tenax Investigational Site
Tucson, Arizona, United States
Tenax Investigational Site
La Jolla, California, United States
Tenax Investigational Site
Los Angeles, California, United States
Tenax Investigational Site
Los Angeles, California, United States
Tenax Investigational Site
Sacramento, California, United States
Tenax Investigational Site
San Francisco, California, United States
Tenax Investigational Site
Torrance, California, United States
Tenax Investigational Site
Jacksonville, Florida, United States
Tenax Investigational Site
Winter Haven, Florida, United States
Tenax Investigational Site
Atlanta, Georgia, United States
Tenax Investigational Site
Chicago, Illinois, United States
Tenax Investigational Site
Chicago, Illinois, United States
Tenax Investigational Site
Galesburg, Illinois, United States
Tenax Investigational Site
Indianapolis, Indiana, United States
Tenax Investigational Site
Indianapolis, Indiana, United States
Tenax Investigational Site
Louisville, Kentucky, United States
Tenax Investigational Site
Boston, Massachusetts, United States
Tenax Investigational Site
Minneapolis, Minnesota, United States
Tenax Investigational Site
Rochester, Minnesota, United States
Tenax Investigational Site
St Louis, Missouri, United States