NCT07914933Recruiting
The Effect of Levosimendan on Pulmonary Artery Pressure and Right Ventricular Function in the Perioperative Period in Patients With CTEPH After Pulmonary Thromboendarterectomy
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
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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). 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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 28 Apr 2026
- Start date
- 29 Apr 2025
- Primary completion date
- Nov 2027
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- NCT number
- NCT07914933
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 29 Apr 2025 to the primary completion date, Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of levosimendan within 30 days prior to screening
- Discontinuation Criteria (or Withdrawal Criteria):
Other illness
- Severe hepatic insufficiency (Child-Pugh score \>9 points)
- History of allergic reaction to levosimendan, Soluvit, or any of their components
- Pulmonary hemorrhage during the perioperative period
Lab values
- Severe renal failture (creatinine clearance \<30 mL/min)
Other
- Patient refusal
- Language barrier preventing understanding of the study
- Participation in other clinical trials
- Need for extracorporeal membrane oxygenation (ECMO) support during the perioperative period
Who the study is looking for
- Voluntary signed informed consent to participate in the study
- Scheduled for pulmonary thromboendarterectomy surgery
- Aged ≥18 years
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Meshalkin Research Institute of Pathology of Circulation Coordinator of this site? Confirm its status | Novosibirsk | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.