The Effect of Levosimendan on Pulmonary Artery Pressure and Right Ventricular Function in the Perioperative Period in Patients With CTEPH After Pulmonary Thromboendarterectomy
NCT07914933, Not applicable, Recruiting, Meshalkin Research Institute of Pathology of Circulation
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | The Effect of Levosimendan on Pulmonary Artery Pressure and Right Ventricular Function in the Perioperative Period in Patients With CTEPH After Pulmonary Thromboendarterectomy | ClinicalTrials.gov |
| NCT number | NCT07914933 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 50 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Meshalkin Research Institute of Pathology of Circulation | ClinicalTrials.gov |
| Conditions | LEVOSIMENDAN, PULMONARY THROMBOENDARTERECTOMY, Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Pulmonary Hypertension | ClinicalTrials.gov |
| Interventions | Infusion of levosimendan, Placebo infusion "Soluvit" | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Mean pulmonary artery pressure (mPAP) | 24 hours at the end of surgery | Mean pulmonary artery pressure (mPAP) measured 24 hours after the end of surgery | ClinicalTrials.gov |
| Secondary | Pulmonary Vascular Resistance (PVR) | • 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 | Pulmonary vascular resistance | ClinicalTrials.gov |
| Secondary | Pulmonary Artery Pulsatility Index (PAPI) | • 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 | 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. | ClinicalTrials.gov |
| Secondary | Pulmonary Artery Pressure (PAP) | • 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 | Pulmonary artery pressure | ClinicalTrials.gov |
| Secondary | Arterial Blood Pressure (ABP) | • 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 | Arterial blood pressure | ClinicalTrials.gov |
| Secondary | Central Venous Pressure (CVP) | • 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 | Central venous pressure | ClinicalTrials.gov |
| Secondary | Cardiac Index (CI) | • 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 | Cardiac index | ClinicalTrials.gov |
| Secondary | Systemic Vascular Resistance (SVR) | • 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 | Systemic vascular resistance | ClinicalTrials.gov |
| Secondary | Right Ventricular Stroke Work Index (RVSWI) | • 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 | Right ventricular stroke work index | ClinicalTrials.gov |
| Secondary | Pulmonary Capillary Wedge Pressure (PAWP) | • 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 | Pulmonary capillary wedge pressure | ClinicalTrials.gov |
| Secondary | Ejection fraction | • before skin incision • at the end of surgery • 24 hours after surgery • 48 hours after surgery • 72 hours after surgery | Ejection fraction (EF) of both the right and left ventricles (LVEF and RVEF) | ClinicalTrials.gov |
| Secondary | Right Ventricular End-Diastolic Volume (RVEDV) | • before skin incision • at the end of surgery • 24 hours after surgery • 48 hours after surgery • 72 hours after surgery | Right ventricular end diastolic volume | ClinicalTrials.gov |
| Secondary | Right Ventricular systolic pressure (RVSP) | • before skin incision • at the end of surgery • 24 hours after surgery • 48 hours after surgery • 72 hours after surgery | Right ventricular systolic pressure | ClinicalTrials.gov |
| Secondary | Fractional area change (FAC) of the right ventricle | • before skin incision • at the end of surgery • 24 hours after surgery • 48 hours after surgery • 72 hours after surgery | Fractional area change (FAC) of the right ventricle | ClinicalTrials.gov |
| Secondary | Tricuspid annular plane systolic excursion (TAPSE) | • before skin incision • at the end of surgery • 24 hours after surgery • 48 hours after surgery • 72 hours after surgery | Tricuspid annular plane systolic excursion | ClinicalTrials.gov |
| Secondary | Right ventricular free-wall longitudinal strain (RV FW LS) | • before skin incision • at the end of surgery • 24 hours after surgery • 48 hours after surgery • 72 hours after surgery | Right ventricular free-wall longitudinal strain | ClinicalTrials.gov |
| Secondary | Quantitative troponin I level | • before skin incision• 24 hours after the end of surgery• 48 hours after surgery | Quantitative concentration of troponin I | ClinicalTrials.gov |
| Secondary | Vasoactive Inotropic Support | • before skin incision • at the end of surgery • 4 hours after surgery • 24 hours after surgery • 48 hours after surgery • 72 hours after surgery | 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)) | ClinicalTrials.gov |
| Secondary | Residual Pulmonary Hypertension | From the end of surgery up to 72 hours postoperatively | 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). | ClinicalTrials.gov |
| Secondary | Incidence of reperfusion pulmonary edema | From the end of surgery up to 72 hours postoperatively | 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) | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 19
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 15083767 | BACKGROUND | PubMed |
| 18570382 | BACKGROUND | PubMed |
| 18981240 | BACKGROUND | PubMed |
| 21335128 | BACKGROUND | PubMed |
| 26028638 | BACKGROUND | PubMed |
| 26252755 | BACKGROUND | PubMed |
| 26826181 | BACKGROUND | PubMed |
| 27052413 | BACKGROUND | PubMed |
| 29979110 | BACKGROUND | PubMed |
| 30052230 | BACKGROUND | PubMed |
| 30545968 | BACKGROUND | PubMed |
| 33541611 | BACKGROUND | PubMed |
| 36028254 | BACKGROUND | PubMed |
| 36722588 | BACKGROUND | PubMed |
| 37051026 | BACKGROUND | PubMed |
| 37051490 | BACKGROUND | PubMed |
| 38302154 | BACKGROUND | PubMed |
| 39036117 | BACKGROUND | PubMed |
| 39209473 | BACKGROUND | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)