At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- TNX-103 (drug), Placebo (drug)
- How long the study runs
- Study runs about 39 months (dates as stated)
- About the drug or intervention
- TNX-103 — drug: Oral levosimendan · Placebo — drug: Matching placebo (oral)
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, called LEVEL-2, is looking at whether a medicine called levosimendan can help improve exercise limits in people with a type of pulmonary hypertension (high blood pressure in the lungs) linked to heart failure where the heart pumps normally but is stiff (called PH-HFpEF). It is funded by Tenax Therapeutics, Inc. Not stated — ask the trial team for more detail on what the study involves.
Who can take part
- Men or women aged 18 to 85
- Heart symptom classes NYHA (New York Heart Association) Class II, III, or ambulatory Class IV — a doctor grades how much symptoms limit activity
- A diagnosis of WHO (World Health Organization) Group 2 PH-HFpEF, confirmed with a test called right heart catheterisation (a thin tube into the heart to measure pressures)
- A qualifying baseline right heart catheterisation test
- A qualifying echocardiogram (heart ultrasound scan)
- A qualifying 6-minute walking distance test
- Wearing a heart rhythm monitor for 48 hours during the screening period
- Rules about pregnancy risk, contraception, and egg or sperm donation apply — ask the trial team
Who may not be able to
- Pulmonary hypertension from WHO Groups 1, 3, 4, or 5
- Heart conditions such as hypertrophic or restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrative cardiomyopathy seen on a heart scan
- Heart valve repair or replacement (surgery or keyhole), planned valve treatment, or significant valve disease
- Existing lung disease
- Severe allergy or bad reaction to ingredients in the study medicine
- Major surgery in the last 60 days
- Previous heart, lung, or heart-lung transplant, or a life expectancy of under 12 months
- Other serious health problems that could make taking part difficult
What taking part involves
- • The study medicine is levosimendan. Not stated — ask the trial team how it is given, how often, and for how long
Time commitment: Not stated — ask the trial team how many visits there are, how long the study lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 85 Years
- Who
- All
- Number of participants
- 540
- Started
- 2026-03-03
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for pulmonary hypertension associated with hfpef
- • Phase3 - 540 participants
- • 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 take part?
- • Ages 18 Years to 85 Years
- • Diagnosed with pulmonary hypertension associated with hfpef
Where?
- • Cambridge - Tenax Investigational Site
- • Glasgow - Tenax Investigational Site
- • London - Tenax Investigational Site
- • London - Tenax Investigational Site
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
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.
More detail
Approximately 540 participants will be randomized in a 2:1 ratio to receive an oral dose of levosimendan or placebo. Participants will be eligible for an open label extension (OLE) of 52-weeks.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 85 Years
- Who can join: All genders
What the study is looking for
- ✓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...
- ✓A qualifying baseline RHC
- ✓A qualifying echocardiogram
Who cannot take part
- ✗A diagnosis of PH WHO Groups 1, 3, 4, or 5
- ✗Echocardiographic evidence for hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis,...
- ✗Structural heart repair or replacement of the aortic valve or mitral valve (surgical or percutaneous) OR, planned...
- ✗A diagnosis of pre-existing lung disease
- ✗History of severe allergic or anaphylactic reaction or hypersensitivity to the excipients in the the the study treatment
See the full criteria
Where Is This Study? (6 UK sites)
Tenax Investigational Site
Cambridge CB233RE, United Kingdom
Tenax Investigational Site
Glasgow G81 4HS, United Kingdom
Tenax Investigational Site
London SW3 6NP, United Kingdom
Tenax Investigational Site
London W12 0HS, United Kingdom
Tenax Investigational Site
Sheffield S10 2JF, United Kingdom
Tenax Investigational Site
Swindon SN36BB, United Kingdom
How to Get in Touch
Akshata Ashokkumar
Sponsor contactCONTACT
Katelyn Jansson
Sponsor contactCONTACT