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NCT05768230

Using TEE to Evaluate the Effect of Levosimendan on Patients With ARDS Associated With RVD During MV

Status unknown Phase 2, PHASE3 Last updated 14 March 2023
What this trial tests

Phase 2, PHASE3 trial testing levosimendan in Transesophageal Echocardiography in 58 participants. Status unknown.

Timeline
22 March 2023
Primary endpoint
1 December 2025
1 December 2025

Quick facts

Lead sponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
PhasePhase 2, PHASE3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment58
Start date22 March 2023
Primary completion1 December 2025
Estimated completion1 December 2025
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Who can join

Adults 18 to 80, any sex, with Transesophageal Echocardiography or Acute Respiratory Distress Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Acute respiratory distress syndrome (ARDS) is often complicated by right ventricular dysfunction (RVD), Acute cor pulmonale is the most serious form of ARDS complicated with RVD.Levosimendan is indicated for short-term treatment of acute decompensated heart failure that is not responding well to conventional therapy and requires increased myocardial contractile force.In 2016, the European Society of Cardiology issued recommendations for the management of acute right heart failure, stating that levosimendan can improve right ventriculo-pulmonary artery coupling by both increasing right heart contractility and reducing pulmonary vascular resistance.However, the clinical application of levosimendan in the treatment of ARDS right heart dysfunction is insufficient.Therefore, this study intends to use transesophageal ultrasound to evaluate right ventricular function, reduce the limitation of poor right ventricular window in transthoracic echocardiography, and conduct a multi-center randomized controlled study to further explore the effects of levosimendan on right ventricular function in ARDS patients, such as tricuspid ring systolic displacement (TAPSE) and tricuspid ring systolic displacement velocity (S '). Effects of right ventricular area change fraction (RV FAC), right ventricular end-diastolic area/left ventricular end-diastolic area (RVEDA/LVEDA), pulmonary circulation resistance (PVR), hemodynamics and mortality.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of levosimendan

Trials testing the same drug.

Other recruiting trials for Transesophageal Echocardiography

Currently open trials in the same condition.

Other Union Hospital, Tongji Medical College, Huazhong University of Science and Technology trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05768230.

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