NCT07288398 · Tenax Therapeutics, Inc.
LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2
(LEVEL-2)
What this study is about
The purpose of this study is to assess the effectiveness and safety of the study drug, levosimendan (given taken by mouth), 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.
View original scientific description
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 can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Men or women, ≥18 to 85 years of age
- NYHA Class II or III or ambulatory NYHA Class IV symptoms
- A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics verified by right heart catheterization (RHC)
- A qualifying baseline RHC
- A qualifying echocardiogram
- A 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)
Exclusion criteria
- 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
Where
- Alexander City, Alabama
- Tamarac, Florida
- Mount Prospect, Illinois
- Peoria, Illinois
- New Orleans, Louisiana
- West Monroe, Louisiana
- Ypsilanti, Michigan
- Reno, Nevada
- New York, New York
- Winston-Salem, North Carolina
- Allentown, Pennsylvania
- Wynnewood, Pennsylvania
And 6 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 16, 2026 · Source of record for eligibility and locations