A study to evaluate the effectiveness of levosimendan in patients with pulmonary hypertension and heart failure with preserved ejection fraction.

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What is this study about?

This study focuses on individuals living with Pulmonary Hypertension, a condition where the blood pressure in the arteries of the lungs is too high, specifically in those who also have Heart Failure with Preserved Ejection Fraction. This type of heart failure occurs when the heart muscle becomes stiff and cannot relax properly to fill with blood between beats, even though the heart’s ability to pump blood out remains relatively normal. The purpose of the study is to evaluate the effectiveness and safety of a medication called levosimendan compared to a placebo.

Participants in the study will be assigned to receive either the active medication, levosimendan, or a placebo, which is an inactive substance, through an oral hard gelatin capsule. This assignment is done through a randomized process, meaning it is determined by chance, and a double-blind method, where neither the participants nor the researchers know which substance is being administered. The treatment period lasts for 26 weeks, during which the effects on physical activity and general health are monitored.

Who Can Join the Study?

  • Participants must be men or women aged between 18 and 85 years.
  • Patients must have symptoms categorized as NYHA Class II, III, or ambulatory Class IV, which refers to a system used to classify the severity of heart failure based on how much physical activity causes shortness of breath or fatigue.
  • A diagnosis of WHO Group 2 Pulmonary Hypertension with preserved left ventricular ejection fraction is required. This means there is high blood pressure in the arteries of the lungs caused by issues with the left side of the heart.
  • The diagnosis must be confirmed through a right heart catheterization, which is a procedure where a thin tube is inserted into the heart to measure blood pressure and oxygen levels directly.
  • A recent echocardiogram (an ultrasound of the heart) performed within 45 days must show a left ventricular ejection fraction of 40% or higher. The ejection fraction is a measurement of how much blood the main pumping chamber of the heart pushes out with each beat.
  • Tests must prove the absence of a pulmonary thromboembolism, which is a blood clot that has traveled to the lungs. This must be confirmed by a ventilation-perfusion scan, a specialized imaging test, or a computed tomography pulmonary angiogram, which is a detailed X-ray scan of the lung arteries.
  • During the initial screening and at the start of the study, patients must be able to walk between 100 and 450 meters in a 6-Minute Walk Test, which is a test used to measure how much distance a person can cover on foot in six minutes to assess their physical endurance.

Who Cannot Join the Study?

  • You cannot join if you have certain types of Pulmonary Hypertension (high blood pressure in the lung arteries) that fall into specific medical categories known as WHO Groups 1, 3, 4, or 5.
  • You are excluded if an echocardiogram (an ultrasound of the heart) shows specific heart muscle or lining problems, such as hypertrophic cardiomyopathy (thickened heart muscle), restrictive cardiomyopathy (stiff heart muscle), constrictive pericarditis (inflammation that prevents the heart from filling properly), cardiac amyloidosis (buildup of abnormal proteins in the heart), or infiltrative cardiomyopathy (heart muscle affected by substances that seep into the tissue).
  • You cannot participate if you had heart surgery to repair or replace the aortic valve or mitral valve in the last 24 months, or if you have a surgery planned for these valves in the next 24 months.
  • You are excluded if an echocardiogram shows significant valve disease, specifically mitral regurgitation (blood leaking backward through the mitral valve) at a high grade, mitral stenosis (narrowing of the mitral valve), aortic regurgitation (blood leaking backward through the aortic valve) at a certain grade, or aortic stenosis (narrowing of the aortic valve).
  • You cannot join if your recent blood tests show hemoglobin (a protein in red blood cells that carries oxygen) levels below 10 g/dL.
  • You are excluded if your liver tests, specifically ALT, AST, or total bilirubin (indicators of liver health), are more than three times the upper limit of normal.
  • You cannot participate if your ECG (a test that records the electrical activity of the heart) shows a QT interval (the time it takes for the heart muscle to recharge between beats) that is too long, measured using a specific formula, unless you have a specific heart rhythm condition like a bundle branch block or a paced rhythm (heartbeat controlled by a device).
  • You are excluded if your platelet count (cells that help blood clot) is below 75,000/mm3.
  • You cannot join if you have physical issues that might affect breathing, such as congenital abnormalities (birth defects) of the lungs, chest, or diaphragm, having had a pneumonectomy (removal of part or all of a lung), or having received radiation therapy to the lungs or middle of the chest.
  • You are excluded if there is recent evidence of significant underlying lung disease.
  • You cannot participate if you had a pulmonary thromboembolism (a blood clot in the lung) in the last 12 months, confirmed by special imaging scans.
  • You are excluded if you have certain heart-related conditions, such as untreated coronary artery disease (narrowing of the heart’s blood vessels) or acute coronary syndrome (a sudden reduction of blood flow to the heart).
  • You cannot join if you had a coronary artery bypass graft (surgery to redirect blood flow around blocked arteries) or a percutaneous coronary intervention (a procedure to open blocked heart arteries) within the last 180 days.
  • You are excluded if you have an uncontrolled heart rate caused by atrial fibrillation or atrial flutter (irregular or rapid heart rhythms).
  • You cannot participate if you have a history of untreated, life-threatening arrhythmia (irregular heartbeat) or if you are expected to receive a heart transplant or a ventricular assist device (a mechanical pump to help the heart).
  • You are excluded if you are scheduled to get a pacemaker (a small device that regulates the heartbeat) or if you received one within the last 30 days.
  • You cannot join if you had a myocardial infarction (a heart attack) caused by heart artery disease within the last 180 days.
  • You are excluded if you have uncontrolled systemic hypertension (high blood pressure throughout the body) with a top number (systolic blood pressure) higher than 170 mmHg.
  • You cannot participate if you had a stroke within the last 90 days.
  • You are excluded if your systolic blood pressure (the pressure in your arteries when your heart beats) is lower than 100 mmHg during your initial checks.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Central Hospital Of Northern Pest Military Hospital Budapest Hungary
Noe LGA Gesundheit Region Mitte GmbH St. Poelten Austria
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Hospital Clinic De Barcelona Barcelona Spain
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Centre Hospitalier Universitaire De Montpellier Montpellier France
Klinik Favoriten Vienna Austria
Hospital Universitario Lucus Augusti Lugo Spain
Centre Hospitalier Universitaire De Nantes Nantes France
Kerckhoff-Klinik GmbH Bad Nauheim Germany
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
A.O.U. Policlinico G. Martino Di Messina Messina Italy
Centro Cardiologico Monzino S.p.A. Milan Italy
Fondazione Toscana Gabriele Monasterio Pisa Italy
A.O. Krankenhaus St. Josef Braunau GmbH Braunau Am Inn Austria
BG Klinikum Unfallkrankenhaus Berlin gGmbH Berlin Germany
Consorci Mar Parc De Salut De Barcelona Barcelona Spain
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
University Of Debrecen Debrecen Hungary
Semmelweis University Budapest Hungary
Centre Hospitalier Universitaire De Nice Nice France
Hopital Beaujon Clichy France
Multi-profile Hospital for Active Treatment Heart and Brain EAD Pleven Bulgaria
University Of Szeged Szeged Hungary
Samodzielny Publiczny Specjalistyczny Szpital Zachodni Im.Sw.Jana Pawla II Grodzisk Mazowiecki Poland
Hospital Costa del Sol Marbella Spain
Centre Hospitalier De Pau Pau France
Hospital Universitario Virgen De La Victoria Malaga Spain
Mestska Nemocnice Ostrava Prispevkova Organizace Moravska Ostrava A Privoz Czechia
Udqsjtltnh Hbhshndz Lppwqswn Sofia Bulgaria
Uvuutdglob Mannndy Cggydp Hkjbyzkmyeqjlhfqp Hamburg Germany
Fijjhkud namkapftv Mporn a Huupdek Prague Czechia
Kzmhmraz Kreasewmvx ap Wmzguqioio Klagenfurt am Wörthersee Austria
Fixlritpq Pmgl Lk Iqbomliypetnb Bkfdwcnoa Dtk Haxesuza Uxscoqruenfpz Lg Pjd Madrid Spain
Dxcueooiaw Czwdqkbjmfbr Crsjex (ajvk &rwaxwzrlnlp Asvzeqapzio Exrp Sofia Bulgaria
Hsbcottl Vjyl dxbftcmc Barcelona Spain
Mpctfjn Cwyavz Mmhlzydrrc &xskhun Bpctmc Burgas Bulgaria
Iugdo Ociuubdz Axekstamah Smq Lrid Milan Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
05.01.2026
Bulgaria Bulgaria
Not yet recruiting
05.01.2026
Czechia Czechia
Not yet recruiting
05.01.2026
France France
Not yet recruiting
05.01.2026
Germany Germany
Not yet recruiting
05.01.2026
Hungary Hungary
Not yet recruiting
05.01.2026
Italy Italy
Not yet recruiting
05.01.2026
Poland Poland
Not yet recruiting
05.01.2026
Spain Spain
Not yet recruiting
05.01.2026

Trial locations

Investigated drugs:

Levosimendan is a medication taken by mouth that is being studied to see how well it helps people with pulmonary hypertension who also have heart failure. It is intended to improve the patient’s ability to walk and overall physical function.

Pulmonary hypertension with heart failure with preserved ejection fraction – This condition occurs when there is high blood pressure in the arteries that connect the heart to the lungs. At the same time, the left side of the heart becomes stiff and cannot relax properly between beats. This stiffness prevents the heart from filling with enough blood to pump effectively. As the disease progresses, the increased pressure in the lung vessels makes it harder for the heart to move blood through the body. This can lead to a buildup of fluid and increased strain on the heart muscles.

Trial ID:
2025-522475-28-00
Protocol code:
TNX-103-07
NCT ID:
NCT05983250
Trial Phase:
Therapeutic confirmatory (Phase III)

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