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LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2
EU CTIS ID: 2025-522475-28-00
What this study is testing
"Efficacy: Evaluate the efficacy of 26 weeks of treatment with levosimendan (TNX-103) compared with placebo in patients with PH-HFpEF as measured by the change in 6-Minute Walk Distance (6 MWD) Safety: To evaluate the safety and tolerability of oral levosimendan versus placebo"
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Men or women, ≥18 to 85 years of age.
- 2. NYHA Class II or III or ambulatory NYHA Class IV symptoms.
- 3. A diagnosis of WHO Group 2 PH-HFpEF with qualifying hemodynamics verified by right heart catheterization
- 4. A qualifying echocardiogram performed within 45 days of Day 1 (ie within the Screening Period) showing a left ventricular ejection fraction ≥40%.
- 5. Documentation of the absence of pulmonary thromboembolism by ventilation-perfusion scan, computed tomography pulmonary angiogram, or pulmonary angiography performed within 45 days of Day 1.
- 6. A qualifying 6-MWD of at least 100 meters, but not more than 450 meters at Screening (within 45 days of Day 1) AND at the baseline 6-Minute Walk Test (6-MWT) on Day 1.
You likely can't join if
- 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 within the past 24 months. OR, planned valve intervention in the next 24 months. OR, the presence of echocardiographic findings of significant valve disease as assessed from the qualifying echocardiogram and defined as: a. Mitral valve disease grade ≥3 mitral regurgitation or ≥moderate mitral stenosis. b. Aortic valve disease grade ≥2 aortic regurgitation or ≥moderate aortic stenosis
- 4. Any of the following clinical laboratory values within 45 days of Day 1 as specified: a. Hemoglobin <10 g/dL. b. Serum ALT or AST levels >3×ULN or total bilirubin >3×ULN. c. ECG with a heart rate-corrected QT interval using Fridericia’s formula >450 msec for males and >470 msec for females at Screening in the absence of a bundle branch block or ventricularly paced rhythm. d. Platelet count <75,000/mm3.
- 5. Any of the following structural conditions that may compromise pulmonary function: a. Congenital abnormalities of the lungs, thorax or diaphragm, that may significantly contribute to the severity of PH in the opinion of the Investigator. b. A full or partial pneumonectomy. c. Previous therapeutic radiation of lungs or mediastinum.
- 6. Recent documentation of significant underlying lung disease.
See the full eligibility criteria
Who can join
- 1. Men or women, ≥18 to 85 years of age.
- 2. NYHA Class II or III or ambulatory NYHA Class IV symptoms.
- 3. A diagnosis of WHO Group 2 PH-HFpEF with qualifying hemodynamics verified by right heart catheterization
- 4. A qualifying echocardiogram performed within 45 days of Day 1 (ie within the Screening Period) showing a left ventricular ejection fraction ≥40%.
- 5. Documentation of the absence of pulmonary thromboembolism by ventilation-perfusion scan, computed tomography pulmonary angiogram, or pulmonary angiography performed within 45 days of Day 1.
- 6. A qualifying 6-MWD of at least 100 meters, but not more than 450 meters at Screening (within 45 days of Day 1) AND at the baseline 6-Minute Walk Test (6-MWT) on Day 1.
What rules you out
- 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 within the past 24 months. OR, planned valve intervention in the next 24 months. OR, the presence of echocardiographic findings of significant valve disease as assessed from the qualifying echocardiogram and defined as: a. Mitral valve disease grade ≥3 mitral regurgitation or ≥moderate mitral stenosis. b. Aortic valve disease grade ≥2 aortic regurgitation or ≥moderate aortic stenosis
- 4. Any of the following clinical laboratory values within 45 days of Day 1 as specified: a. Hemoglobin <10 g/dL. b. Serum ALT or AST levels >3×ULN or total bilirubin >3×ULN. c. ECG with a heart rate-corrected QT interval using Fridericia’s formula >450 msec for males and >470 msec for females at Screening in the absence of a bundle branch block or ventricularly paced rhythm. d. Platelet count <75,000/mm3.
- 5. Any of the following structural conditions that may compromise pulmonary function: a. Congenital abnormalities of the lungs, thorax or diaphragm, that may significantly contribute to the severity of PH in the opinion of the Investigator. b. A full or partial pneumonectomy. c. Previous therapeutic radiation of lungs or mediastinum.
- 6. Recent documentation of significant underlying lung disease.
- 7. Documentation of pulmonary thromboembolism in the last 12 months by a ventilation-perfusion scan, CT pulmonary angiogram, or a pulmonary angiography with an interpretation other than a normal or low probability result.
- 8. Cardiovascular comorbidities, which include the following: a. Symptomatic or untreated coronary artery disease. b. Acute coronary syndrome, coronary artery bypass graft, or percutaneous coronary intervention; any within 180 days of Day 1. c. Uncontrolled resting heart rate due to atrial fibrillation or atrial flutter at the time of the Screening ambulatory cardiac monitoring. d. History of untreated serious life-threatening or hemodynamically significant arrhythmia. e. History of or anticipated heart transplant or ventricular assist device implantation. f. Anticipated implantation of a pacemaker, or pacemaker implantation within 30 days of Screening. g. Occurrence of myocardial infarction due to epicardial coronary artery disease within 180 days of Day 1. h. Uncontrolled systemic hypertension as evidenced by sitting systolic BP >170 mmHg after a period of rest during the Screening Period. i. Stroke within 90 days of Day 1. j. Systolic BP <100 mmHg at Screening and Day 1.
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- United States
- Korea, Democratic People's Republic of
- United Kingdom
- Taiwan
- Argentina
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brazil; United States; Korea, Democratic People's Republic of; United Kingdom; Taiwan; Argentina. 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 EU CTIS; the study team decides eligibility.