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LEVOSIMENDANLEVO-CTEPHNCT07914933

The Effect of Levosimendan on Pulmonary Artery Pressure and Right Ventricular Function in the Perioperative Period in Patients With CTEPH After Pulmonary Thromboendarterectomy

A study testing Infusion of levosimendan in people with LEVOSIMENDAN and PULMONARY THROMBOENDARTERECTOMY, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

A single-center pilot prospective randomized placebo-controlled double-blind clinical trial. Study objective - to investigate the efficacy and safety of levosimendan in patients in the perioperative period following pulmonary endarterectomy for chronic thromboembolic pulmonary hypertension (CTEPH). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Infusion of levosimendan
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteRussia
Study dates
29 Apr 2025to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary signed informed consent to participate in the study
  • Scheduled for pulmonary thromboendarterectomy surgery
  • Aged ≥18 years

Who cannot join

  • Patient refusal
  • Language barrier preventing understanding of the study
  • Severe renal failture (creatinine clearance <30 mL/min)
  • Severe hepatic insufficiency (Child-Pugh score >9 points)
  • Participation in other clinical trials
  • History of allergic reaction to levosimendan, Soluvit, or any of their components
Show all 10Show fewer
  • Use of levosimendan within 30 days prior to screening
  • Discontinuation Criteria (or Withdrawal Criteria):
  • Need for extracorporeal membrane oxygenation (ECMO) support during the perioperative period
  • Pulmonary hemorrhage during the perioperative period

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Gleb Moroz, PhD contact

+79833177148

g_moroz@meshalkin.ru

Russia1 site, 1 recruiting

  • Meshalkin Research Institute of Pathology of Circulation

    Novosibirsk, 630055

    Recruiting

Other trials in Russia

About this study

Official title: The Effect of Levosimendan on Pulmonary Artery Pressure and Right Ventricular Function in the Perioperative Period in Patients With CTEPH After Pulmonary Thromboendarterectomy: a Single-center Pilot Prospective Randomized Placebo-controlled Double-blind Clinical Trial

A single-center pilot prospective randomized placebo-controlled double-blind clinical trial.

Study objective - to investigate the efficacy and safety of levosimendan in patients in the perioperative period following pulmonary endarterectomy for chronic thromboembolic pulmonary hypertension (CTEPH).

Read more

Research Objectives:

  1. To assess the impact of levosimendan administration on pulmonary artery pressure during the perioperative period in patients who have undergone pulmonary endarterectomy for CTEPH.
  2. To evaluate the effect of levosimendan administration on right ventricular function parameters during the perioperative period in patients after pulmonary endarterectomy for CTEPH.
  3. To determine the influence of levosimendan on the need for inotropic and vasopressor support (VIS) during the perioperative period in patients following pulmonary endarterectomy for CTEPH.
  4. To examine the effect of levosimendan on the clinical course and complications during the postoperative period in patients after pulmonary endarterectomy for CTEPH.
  5. To evaluate the cardioprotective effect of levosimendan in patients following pulmonary endarterectomy for CTEPH.
  6. To assess the impact of levosimendan on in-hospital mortality in patients after pulmonary endarterectomy for CTEPH.
Read the detailed description

Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare and severe form of pulmonary hypertension resulting from thrombotic obstruction of the pulmonary arteries. It is typically a late complication of acute pulmonary embolism. The incidence of CTEPH has been reported to reach 13 cases per million population per year.

Organized thrombotic masses cause stenosis or obstruction of the pulmonary arteries, leading to increased pulmonary artery pressure and pulmonary vascular resistance. This results in redistribution of pulmonary blood flow, microangiopathy, and remodeling of small-caliber pulmonary vessels. Pulmonary endarterectomy (PEA) is the recommended standard of care for patients with CTEPH and can be curative. In experienced centers, mortality rates are less than 5%.

Residual pulmonary hypertension after PEA, defined as a mean pulmonary artery pressure ≥25 mmHg, occurs in 17-51% of patients. This complication is associated with residual thrombotic material in distal pulmonary arteries and small-vessel disease. Severe pulmonary hypertension causes right ventricular maladaptive remodeling and dysfunction, ultimately leading to right ventricular failure, which is the most important determinant of survival and quality of life. Residual pulmonary hypertension negatively affects long-term survival, with higher mortality associated with mean pulmonary artery pressure ≥36 mmHg and pulmonary vascular resistance ≥416 dyn·s·cm-⁵.

Currently, a multimodal approach to CTEPH is being considered. Surgery addresses the primary component by removing thrombotic masses, but pharmacotherapy is required for the microvascular component and persistently elevated pulmonary artery pressure. Targeted therapies are costly, and their benefit remains unclear. Clinical guidelines currently recommend only symptomatic therapy for patients with residual pulmonary hypertension and right ventricular failure after PEA, and no optimal treatment strategy has been defined for this complication in the early postoperative period.

Rationale for Levosimendan: Levosimendan has shown promising effects in pulmonary hypertension and right ventricular failure. Its mechanism of action involves opening ATP-dependent potassium channels in vascular smooth muscle cells, leading to vasodilation and reduction of both preload and afterload. Additionally, levosimendan binds to cardiac troponin C, increasing myofibril contractility. Previous studies have demonstrated that levosimendan reduces pulmonary artery pressure and pulmonary vascular resistance, improves right ventricular function (including increased TAPSE, ejection fraction, and cardiac output), and suppresses smooth muscle cell proliferation in pulmonary arteries. However, no studies to date have investigated the effect of levosimendan in patients with CTEPH undergoing pulmonary endarterectomy, and the drug has not previously been used in the perioperative management of this patient population.

Study objective is to evaluate the effect of levosimendan on pulmonary artery pressure and right ventricular function in patients undergoing pulmonary endarterectomy for CTEPH.

Being tested
Infusion of levosimendan, Placebo infusion "Soluvit"
Keywords
LEVOSIMENDAN, Pulmonary Thromboendarterectomy, Pulmonary Artery Pressure, Right Ventricular Function, Perioperative Period
Medical subject headings
Hypertension, Pulmonary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Infusion of levosimendanDrug

    Infusion of levosimendan will be initiated after the induction of anesthesia, discontinued at the onset of patient cooling, and resumed at the time of rewarming at 34°C. The drug will be administered using an infusion pump as a continuous infusion at a rate of 0.1 mcg/kg/min. The duration of the drug infusion will be up to 48 hours.

    Preoperative management will be conducted according to the patients' primary and concomitant diseases.

  • Placebo infusion "Soluvit"Drug

    Patients in the placebo group will receive an equivalent amount of a colored solution of Soluvit.Soluvit (ATC B05XC; a yellow vitamin mixture indistinguishable from the investigational drug, levosimendan).

    Preoperative management will be conducted according to the patients' primary and concomitant diseases.

Study groups in NCT07914933
Study groupRoleWhat they receive
LevosimendanExperimentalA levosimendan infusion after induction of anesthesia.
Receives: Drug: Infusion of levosimendan
"Soluvit"Placebo comparatorA placebo infusion after induction of anesthesia.
Receives: Drug: Placebo infusion "Soluvit"

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean pulmonary artery pressure (mPAP)

    Mean pulmonary artery pressure (mPAP) measured 24 hours after the end of surgery

    Measured: 24 hours at the end of surgery

Secondary outcomes (32)

  1. Pulmonary Vascular Resistance (PVR)

    Pulmonary vascular resistance

    Measured: • before skin incision • at the end of surgery • 4 hours after of surgery • 24 hours after of surgery • 48 hours after of surgery • 72 hours after of surgery

  2. Pulmonary Artery Pulsatility Index (PAPI)

    Pulmonary artery pulsatility index. PAPi = (PASP - PADP) / RAP (PASP - PADP): Pulmonary Artery Pulse Pressure. This is the difference between the pressure in the pulmonary artery when the heart contracts (systolic) and relaxes (diastolic).

    RAP: Right Atrial Pressure.

    Measured: • before skin incision • at the end of surgery • 4 hours after of surgery • 24 hours after of surgery • 48 hours after of surgery • 72 hours after of surgery

  3. Pulmonary Artery Pressure (PAP)

    Pulmonary artery pressure

    Measured: • before skin incision • at the end of surgery • 4 hours after of surgery • 24 hours after of surgery • 48 hours after of surgery • 72 hours after of surgery

  4. Arterial Blood Pressure (ABP)

    Arterial blood pressure

    Measured: • before skin incision • at the end of surgery • 4 hours after of surgery • 24 hours after of surgery • 48 hours after of surgery • 72 hours after of surgery

  5. Central Venous Pressure (CVP)

    Central venous pressure

    Measured: • before skin incision • at the end of surgery • 4 hours after of surgery • 24 hours after of surgery • 48 hours after of surgery • 72 hours after of surgery

  6. Cardiac Index (CI)

    Cardiac index

    Measured: • before skin incision • at the end of surgery • 4 hours after of surgery • 24 hours after of surgery • 48 hours after of surgery • 72 hours after of surgery

  7. Systemic Vascular Resistance (SVR)

    Systemic vascular resistance

    Measured: • before skin incision • at the end of surgery • 4 hours after of surgery • 24 hours after of surgery • 48 hours after of surgery • 72 hours after of surgery

  8. Right Ventricular Stroke Work Index (RVSWI)

    Right ventricular stroke work index

    Measured: • before skin incision • at the end of surgery • 4 hours after of surgery • 24 hours after of surgery • 48 hours after of surgery • 72 hours after of surgery

  9. Pulmonary Capillary Wedge Pressure (PAWP)

    Pulmonary capillary wedge pressure

    Measured: • before skin incision • at the end of surgery • 4 hours after of surgery • 24 hours after of surgery • 48 hours after of surgery • 72 hours after of surgery

  10. Ejection fraction

    Ejection fraction (EF) of both the right and left ventricles (LVEF and RVEF)

    Measured: • before skin incision • at the end of surgery • 24 hours after surgery • 48 hours after surgery • 72 hours after surgery

  11. Right Ventricular End-Diastolic Volume (RVEDV)

    Right ventricular end diastolic volume

    Measured: • before skin incision • at the end of surgery • 24 hours after surgery • 48 hours after surgery • 72 hours after surgery

  12. Right Ventricular systolic pressure (RVSP)

    Right ventricular systolic pressure

    Measured: • before skin incision • at the end of surgery • 24 hours after surgery • 48 hours after surgery • 72 hours after surgery

  13. Fractional area change (FAC) of the right ventricle

    Fractional area change (FAC) of the right ventricle

    Measured: • before skin incision • at the end of surgery • 24 hours after surgery • 48 hours after surgery • 72 hours after surgery

  14. Tricuspid annular plane systolic excursion (TAPSE)

    Tricuspid annular plane systolic excursion

    Measured: • before skin incision • at the end of surgery • 24 hours after surgery • 48 hours after surgery • 72 hours after surgery

  15. Right ventricular free-wall longitudinal strain (RV FW LS)

    Right ventricular free-wall longitudinal strain

    Measured: • before skin incision • at the end of surgery • 24 hours after surgery • 48 hours after surgery • 72 hours after surgery

  16. Quantitative troponin I level

    Quantitative concentration of troponin I

    Measured: • before skin incision• 24 hours after the end of surgery• 48 hours after surgery

  17. Vasoactive Inotropic Support

    In the perioperative period, the Vasoactive-Inotropic Score (VIS) will be calculated using the following formula:

    VIS = dobutamine (mcg/kg/min) + dopamine (mcg/kg/min) + (100 × epinephrine (mcg/kg/min) + (100 × norepinephrine (mcg/kg/min)) + (10 × milrinone (mcg/kg/min))

    Measured: • before skin incision • at the end of surgery • 4 hours after surgery • 24 hours after surgery • 48 hours after surgery • 72 hours after surgery

  18. Residual Pulmonary Hypertension

    Number of participants with residual pulmonary hypertension, defined as postoperative mean pulmonary artery pressure (mPAP) > 25 mm Hg, measured by right heart catheterization in the postoperative period (up to 72 hours after surgery).

    Measured: From the end of surgery up to 72 hours postoperatively

  19. Incidence of reperfusion pulmonary edema

    Number of participants who develop pulmonary edema within 24 hours following pulmonary endarterectomy (PEA), confirmed by chest X-ray or chest CT and clinical criteria (including dyspnea, hypoxemia, and bilateral infiltrates), characterized by the presence of frothy secretions in the endotracheal tube (ETT), asymmetric opacities on chest X-ray, and an oxygenation index (PaO₂/FiO₂) < 300 mm Hg in the early postoperative period (up to 72 hours)

    Measured: From the end of surgery up to 72 hours postoperatively

  20. Incidence of cardiac arrhythmias

    Proportion of participants who develop any new-onset cardiac arrhythmia (including atrial fibrillation/flutter, ventricular tachycardia) during the study period, as documented by 12-lead ECG or continuous cardiac monitoring.

    Measured: 30 days

  21. Cardiovascular events: myocardial infarction or stroke

    Number of participants with cardiovascular events, defined as myocardial infarction (MI) or stroke (cerebrovascular accident, CVA), occurring during the postoperative period.Myocardial infarction is defined according to the Fourth Universal Definition of Myocardial Infarction (elevated cardiac troponin with at least one of the following: ischemic symptoms, new ischemic ECG changes, or imaging evidence of new loss of viable myocardium). Stroke is defined as an acute episode of focal or global neurological dysfunction caused by infarction or hemorrhage in the brain, spinal cord, or retina, confirmed by neuroimaging (CT or MRI).

    Measured: 30 days

  22. Respiratory Complications: Pneumothorax

    Number of participants with postoperative pneumothorax, defined as the presence of air in the pleural cavity, confirmed by chest X-ray or chest CT, occurring during the postoperative period.

    Measured: 30 days

  23. Neurological Complications: Seizures

    Number of participants with postoperative seizures, defined as a transient occurrence of signs and/or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. Diagnosis is based on clinical assessment and, when available, confirmed by electroencephalography (EEG).

    Measured: From enrollment to the end of treatment at 30 days

  24. Renal complications: acute kidney injury (AKI) according to KDIGO criteria

    Number of participants with postoperative acute kidney injury (AKI), defined and staged according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria, occurring during the early postoperative period (up to 48 hours after surgery). AKI is defined as any of the following: increase in serum creatinine by ≥ 0.3 mg/dL (≥ 26.5 μmol/L) within 48 hours; or increase in serum creatinine to ≥ 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or urine output < 0.5 mL/kg/hour for 6 hours. AKI is staged as follows: Stage 1 (serum creatinine 1.5-1.9 times baseline or ≥ 0.3 mg/dL increase, or urine output < 0.5 mL/kg/hour for 6-12 hours), Stage 2 (serum creatinine 2.0-2.9 times baseline, or urine output < 0.5 mL/kg/hour for ≥ 12 hours), and Stage 3 (serum creatinine ≥ 3.0 times baseline, or increase to ≥ 4.0 mg/dL, or initiation of renal replacement therapy, or urine output < 0.3 mL/kg/hour for ≥ 24 hours, or anuria for ≥ 12 hours).

    Measured: 30 days

  25. Renal replacement therapy (RRT)

    Number of participants who require renal replacement therapy (RRT) in the early postoperative period

    Measured: From enrollment to the end of treatment at 30 days

  26. Use of inhaled nitric oxide (NO) and/or iloprost

    Number of participants requiring administration of inhaled nitric oxide (NO) and/or inhaled iloprost in the postoperative period. for the management of residual pulmonary hypertension or right ventricular dysfunction. This includes administration as monotherapy or in combination

    Measured: 30 days

  27. Blood transfusion

    Number of participants requiring perioperative blood transfusion, including packed red blood cells (PRBCs), fresh frozen plasma (FFP), platelet concentrates, or cryoprecipitate, in the postoperative period. Transfusion requirements will be recorded as the number of participants receiving any transfusion.

    Measured: 30 days

  28. Inotropic/vasopressor support

    Number of participants requiring postoperative inotropic and/or vasopressor support in the early postoperative period

    Measured: From the end of surgery up to 72 hours postoperatively

  29. Duration of mechanical ventilation (MV)

    Total duration of invasive mechanical ventilation (MV) measured in hours (or days) from the time of intubation in the operating room or ICU until successful extubation. This includes the total time on the ventilator, both in the operating room and in the ICU, and includes any episodes of reintubation.

    Measured: 30 days

  30. Duration of ICU stay

    Total length of stay in the intensive care unit (ICU) measured in days from the time of admission to the ICU after surgery until discharge from the ICU to the general ward.

    Measured: 90 days

  31. Duration of hospital stay

    Total length of hospital stay measured in days

    Measured: 90 days

  32. In-hospital mortality

    yes/no

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2026
  2. Study start29 Apr 2025
  3. Primary completionNov 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients undergoing pulmonary endarterectomy under conditions of cardiopulmonary bypass and circulatory arrest will be randomized into two groups: 1. Patients who will receive a levosimendan infusion after induction of anesthesia. 2. Patients who will receive a placebo infusion after induction of anesthesia.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07914933
Sponsor's protocol ID
323
Acronym
LEVO-CTEPH
Status last verified
Jun 2026
First submitted
28 Apr 2026
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data sharing is not planned as this is a single-center study and institutional regulations do not permit sharing of individual patient data.

Publications

  • Kleber FX, Bollmann T, Borst MM, Costard-Jackle A, Ewert R, Kivikko M, Petterson T, Pohjanjousi P, Sonntag S, Wikstrom G. Repetitive dosing of intravenous levosimendan improves pulmonary hemodynamics in patients with pulmonary hypertension: results of a pilot study. J Clin Pharmacol. 2009 Jan;49(1):109-15. doi: 10.1177/0091270008325150. Epub 2008 Nov 3. No abstract available.

    PubMed 18981240

  • Bharathi KS, Pruthi G, Dhananjaya M, Simha PP. The effect of levosimendan on the right ventricular function in patients with right ventricular dysfunction undergoing mitral valve surgery. Ann Card Anaesth. 2023 Jan-Mar;26(1):50-56. doi: 10.4103/aca.aca_179_21.

    PubMed 36722588

  • Kundra TS, Nagaraja PS, Bharathi KS, Kaur P, Manjunatha N. Inhaled levosimendan versus intravenous levosimendan in patients with pulmonary hypertension undergoing mitral valve replacement. Ann Card Anaesth. 2018 Jul-Sep;21(3):328-332. doi: 10.4103/aca.ACA_19_18.

    PubMed 30052230

  • Robertson IM, Baryshnikova OK, Li MX, Sykes BD. Defining the binding site of levosimendan and its analogues in a regulatory cardiac troponin C-troponin I complex. Biochemistry. 2008 Jul 15;47(28):7485-95. doi: 10.1021/bi800438k. Epub 2008 Jun 21.

    PubMed 18570382

  • Ali R, Sajjad W, Mushtaq I, Farooqi H, Sohail A, Wazir Khan H, Tabasum P, Haseeb A, Ismail WU. Unlocking the Therapeutic Symphony: A Systematic Review Exploring the Role of Levosimendan in the Management of Heart Failure. Cureus. 2024 Jun 20;16(6):e62799. doi: 10.7759/cureus.62799. eCollection 2024 Jun.

    PubMed 39036117

  • Hansen MS, Andersen A, Nielsen-Kudsk JE. Levosimendan in pulmonary hypertension and right heart failure. Pulm Circ. 2018 Jul-Sep;8(3):2045894018790905. doi: 10.1177/2045894018790905. Epub 2018 Jul 6.

    PubMed 29979110

  • Cannon JE, Su L, Kiely DG, Page K, Toshner M, Swietlik E, Treacy C, Ponnaberanam A, Condliffe R, Sheares K, Taboada D, Dunning J, Tsui S, Ng C, Gopalan D, Screaton N, Elliot C, Gibbs S, Howard L, Corris P, Lordan J, Johnson M, Peacock A, MacKenzie-Ross R, Schreiber B, Coghlan G, Dimopoulos K, Wort SJ, Gaine S, Moledina S, Jenkins DP, Pepke-Zaba J. Dynamic Risk Stratification of Patient Long-Term Outcome After Pulmonary Endarterectomy: Results From the United Kingdom National Cohort. Circulation. 2016 May 3;133(18):1761-71. doi: 10.1161/CIRCULATIONAHA.115.019470. Epub 2016 Apr 6.

    PubMed 27052413

  • Ishida K, Kohno H, Matsuura K, Sugiura T, Sanada TJ, Naito A, Shigeta A, Suda R, Sekine A, Masuda M, Sakao S, Tanabe N, Tatsumi K, Matsumiya G. Impact of residual pulmonary hypertension on long-term outcomes after pulmonary endarterectomy in the modern era. Pulm Circ. 2023 Apr 1;13(2):e12215. doi: 10.1002/pul2.12215. eCollection 2023 Apr.

    PubMed 37051490

  • Mayer E, Jenkins D, Lindner J, D'Armini A, Kloek J, Meyns B, Ilkjaer LB, Klepetko W, Delcroix M, Lang I, Pepke-Zaba J, Simonneau G, Dartevelle P. Surgical management and outcome of patients with chronic thromboembolic pulmonary hypertension: results from an international prospective registry. J Thorac Cardiovasc Surg. 2011 Mar;141(3):702-10. doi: 10.1016/j.jtcvs.2010.11.024.

    PubMed 21335128

  • Delcroix M, Lang I, Pepke-Zaba J, Jansa P, D'Armini AM, Snijder R, Bresser P, Torbicki A, Mellemkjaer S, Lewczuk J, Simkova I, Barbera JA, de Perrot M, Hoeper MM, Gaine S, Speich R, Gomez-Sanchez MA, Kovacs G, Jais X, Ambroz D, Treacy C, Morsolini M, Jenkins D, Lindner J, Dartevelle P, Mayer E, Simonneau G. Long-Term Outcome of Patients With Chronic Thromboembolic Pulmonary Hypertension: Results From an International Prospective Registry. Circulation. 2016 Mar 1;133(9):859-71. doi: 10.1161/CIRCULATIONAHA.115.016522. Epub 2016 Jan 29.

    PubMed 26826181

  • Llucia-Valldeperas A, de Man FS, Bogaard HJ. Adaptation and Maladaptation of the Right Ventricle in Pulmonary Vascular Diseases. Clin Chest Med. 2021 Mar;42(1):179-194. doi: 10.1016/j.ccm.2020.11.010. Epub 2021 Jan 12.

    PubMed 33541611

  • Jujo T, Sakao S, Ishibashi-Ueda H, Ishida K, Naito A, Sugiura T, Shigeta A, Tanabe N, Masuda M, Tatsumi K. Evaluation of the Microcirculation in Chronic Thromboembolic Pulmonary Hypertension Patients: The Impact of Pulmonary Arterial Remodeling on Postoperative and Follow-Up Pulmonary Arterial Pressure and Vascular Resistance. PLoS One. 2015 Aug 7;10(8):e0133167. doi: 10.1371/journal.pone.0133167. eCollection 2015.

    PubMed 26252755

  • Kim NH, D'Armini AM, Delcroix M, Jais X, Jevnikar M, Madani MM, Matsubara H, Palazzini M, Wiedenroth CB, Simonneau G, Jenkins DP. Chronic thromboembolic pulmonary disease. Eur Respir J. 2024 Oct 31;64(4):2401294. doi: 10.1183/13993003.01294-2024. Print 2024 Oct.

    PubMed 39209473

  • Jenkins D. Pulmonary endarterectomy: the potentially curative treatment for patients with chronic thromboembolic pulmonary hypertension. Eur Respir Rev. 2015 Jun;24(136):263-71. doi: 10.1183/16000617.00000815.

    PubMed 26028638

  • Dartevelle P, Fadel E, Mussot S, Chapelier A, Herve P, de Perrot M, Cerrina J, Ladurie FL, Lehouerou D, Humbert M, Sitbon O, Simonneau G. Chronic thromboembolic pulmonary hypertension. Eur Respir J. 2004 Apr;23(4):637-48. doi: 10.1183/09031936.04.00079704.

    PubMed 15083767

Questions about this trial

What is this clinical trial studying?

A study testing Infusion of levosimendan in people with LEVOSIMENDAN and PULMONARY THROMBOENDARTERECTOMY, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gleb Moroz, PhD (+79833177148, g_moroz@meshalkin.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean pulmonary artery pressure (mPAP) (time frame: 24 hours at the end of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07914933, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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