Right Ventricle Dysfunction in Patients Undergoing Lung Transplant

NCT05855148 | Completed

• 1 other identifier: 754_2019
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Patients enlisted for bilateral lung transplantation (LUTX) have subclinical right ventricle (RV) dysfunction1, which is usually clinically silent until LUTX. During LUTX, several reasons (i.e., sequential pulmonary arteries cross-clamp, hypoxia, hypercapnia) lead to de-compensation of RV function, cardiac failure and shock2. In this clinical scenario, extracorporeal life support (ECLS) with cardiopulmonary bypass (CBP) or extracorporeal membrane oxygenation (ECMO) is emergently implemented. ECLS is associated with prolonged mechanical ventilation, primary graft dysfunction (PGD), bleeding, and graft rejection3. This may be due to: 1) the activation of pro-inflammatory cascade due to blood-circuit contact; 2) the increased need for allogenic blood components, which per se has been associated to an increased risk of PGD4. Avoiding intraoperative ECLS may thus have significant positive clinical outcomes. In the general cohort of patients undergoing LUTX, pulmonary hypertension, and right ventricular dysfunction have been identified as risk factors for intraoperative ECLS5. At enlistment for LUTX, patients undergo a comprehensive evaluation of right cardiac function comprising: transthoracic echocardiography, pulmonary artery catheterization, and calculation of RV ejection fraction (RVEF) by multiple gated radionuclide ventriculography. Echocardiography is non-invasive, can be performed repeatedly and at the bedside. The free-wall RV longitudinal strain (RVLS) is a novel echocardiographic method for quantification of myocardial deformation6 with high diagnostic accuracy to predict depressed RV ejection fraction. RVLS may be used for non-invasive, repeated and bedside assessment of RV function before LUTX. We envision the employment of RVLS to document subclinical RV dysfunction before LUTX.

Conditions

Lung Transplant; Right Ventricular Failure

Keywords

lung transplant; right ventricle failure; free-wall RV longitudinal strain

Outcome Measures

Primary Outcomes (1)

• free-wall RV longitudinal strain

  echographic measurement of right ventricle contractility

  free-wall RV longitudinal strain will be assessed at the moment of enlistment for lung transplant. Exact time obviously cannot be predicted (given that time from enlistment to transplant may vary widely), but usually is 6 months prior to surgery.

Secondary Outcomes (3)

• TAPSE: tricuspid annular plane systolic excursion

  free-wall RV longitudinal strain will be assessed at the moment of enlistment for lung transplant. Exact time obviously cannot be predicted (given that time from enlistment to transplant may vary widely), but usually is 6 months prior to surgery.

• FAC: fractional area change

  free-wall RV longitudinal strain will be assessed at the moment of enlistment for lung transplant. Exact time obviously cannot be predicted (given that time from enlistment to transplant may vary widely), but usually is 6 months prior to surgery.

• S': tissue Doppler positive peak systolic wave velocity

  free-wall RV longitudinal strain will be assessed at the moment of enlistment for lung transplant. Exact time obviously cannot be predicted (given that time from enlistment to transplant may vary widely), but usually is 6 months prior to surgery.

Study Arms (1)

Lung Transplant Candidates

patients enlisted for lung transplant

Procedure: Enlistment For Lung Transplant

Interventions

Enlistment For Lung Transplant PROCEDURE

All included patients are enlisted for lung transplantation

Lung Transplant Candidates

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients enlisted for lung transplantation

You may qualify if:

• Enlistment for bilateral LUTX
• Age \> 18 years
• Signed informed consent

You may not qualify if:

• Age \< 18 years old
• Urgency enlistment
• Already undergone LUTX
• Extracorporeal membrane oxygenation (ECMO) bridging to LUTX
• Poor acoustic windows which limit the adequate acquisition of the echocardiographic pictures
• Congenital heart disease
• Previous cardiac surgery

Sponsors & Collaborators

• Policlinico Hospital: lead

Study Sites (1)

Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Lung Transplantation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pulmonary Surgical Procedures; Thoracic Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: May 11, 2023
• Study Start: January 1, 2019
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: May 11, 2023

Record last verified: 2023-05

Locations

IT (1)