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New treatment option for Pulmonary Hypertension
Official title LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF
ClinicalTrials.gov ID: NCT05983250
What this study is testing
What is TNX-103?
TNX-103 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for pulmonary hypertension.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Men or women, greater than or equal to18 to 85 years of age.
- NYHA Class II or III or NYHA class IV symptoms.
- A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics
- Qualifying Baseline RHC.
- Qualifying echocardiogram
You likely can't join if
- A diagnosis of PH WHO Groups 1, 3, 4, or 5.
- Echocardiographic evidence for hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or...
- Structural heart repair or replacement of the aortic valve or mitral valve (surgical or percutaneous). OR, planned valve intervention. OR, the...
- A diagnosis of pre-existing lung disease
- History of severe allergic or anaphylactic reaction or hypersensitivity to the excipients in the investigational product.
- Major surgery within 60 days.
See the full eligibility criteria
- Men or women, greater than or equal to18 to 85 years of age.
- NYHA Class II or III or NYHA class IV symptoms.
- A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics
- Qualifying Baseline RHC.
- Qualifying echocardiogram
- Qualifying 6-MWD
- A 48-hour ambulatory cardiac rhythm monitor during the Screening Period.
- Requirements related to child bearing potential, contraception, and egg/sperm donation
- A diagnosis of PH WHO Groups 1, 3, 4, or 5.
- Echocardiographic evidence for hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrative cardiomyopathy
- 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
- A diagnosis of pre-existing lung disease
- History of severe allergic or anaphylactic reaction or hypersensitivity to the excipients in the investigational product.
- Major surgery within 60 days.
- Prior heart, lung, or heart-lung transplants or life expectancy of \<12 months
- History of clinically significant other diseases that may limit or complicate participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Torrance, California, United States
- Jacksonville, Florida, United States
- Winter Haven, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Galesburg, Illinois, United States
- Indianapolis, Indiana, United States
- Louisville, Kentucky, United States
- Boston, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Rochester, New York, United States
+ 17 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; La Jolla, California, United States; Los Angeles, California, United States; Sacramento, California, United States; San Francisco, California, United States; Torrance, California, United States and 31 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.