Levosimendan to see if it helps the heart after PEA in CTEPH

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this single-center pilot study, adults undergoing pulmonary endarterectomy for CTEPH are randomized to receiveslevosimendan or a placebo infusion in the perioperative period. The aim is to see if levosimendan lowers pulmonary artery pressure and improves right ventricular function, while reducing the need for additional inotropic and vasopressor support. Safety and postoperative course are also monitored to identify potential benefits or risks. The study reflects a targeted, early-phase approach to address residual pulmonary hypertension and right heart strain after surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria :

* 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
* 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

Where it's running

• Meshalkin Research Institute of Pathology of Circulation
  Novosibirsk, Russia Recruiting

Study contacts

• Study coordinator: Gleb Moroz, PhD
• Email: g_moroz@meshalkin.ru
• Phone: +79833177148

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.