Trajectories of FEV1 After Lung Transplantation

NCT05934617 | Enrolling By Invitation DMC

• 1 other identifier: TRAJLUNG001
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

For individuals with ESLD, lung transplantation is the best, or only treatment option with increased pulmonary function and quality of life. The forced expiratory volume in one second (FEV1) is the standard to monitor the lung function after transplantation. The goal of this study is to identify and validate the FEV1 trajectories after lung transplantation, as well as their determinants and outcomes, using an international cohort of lung recipients.

Conditions

Lung Transplant Failure and Rejection; Chronic Lung Allograft Dysfunction

Keywords

Lung trajectories; Unsupervised analysis; Determinants of FEV1 trajectories

Outcome Measures

Primary Outcomes (1)

• FEV1 trajectories

  FEV1 trajectories of the lung recipient

  Up to 10 years after lung transplantation

Secondary Outcomes (3)

• Patient death

  Up to 10 years after lung transplantation

• Allograft failure

  Up to 10 years after lung transplantation

• Chronic lung allograft dysfunction

  Up to 10 years after lung transplantation

Study Arms (12)

Foch hospital

Lung recipients from Foch hospital, Suresnes, France

Bichat hospital

Lung recipients from Bichat hospital, Paris, France

Nantes hospital

Lung recipients from Nantes hospital, Nantes, France

San Antonio center

Lung recipients from Pulmonary hypertension center, San Antonio, Texas, US

Marie-Lannelongue hospital

Lung recipients from Marie-Lannelongue hospital, Le Plessis-Robinson, France

Bordeaux hospital

Lung recipients from Bordeaux hospital, Nantes, France

Marseille hospital

Lung recipients from Marseille hospital, Marseille, France

Toulouse hospital

Lung recipients from Toulouse hospital, Toulouse, France

Strasbourg hospital

Lung recipients from Strasbourg hospital, Strasbourg, France

Grenoble hospital

Lung recipients from Grenoble hospital, Grenoble, France

Cochin hospital

Lung recipients from Strasbourg hospital, Paris, France

Hospital center Mayenne North

Lung recipients from Hospital center Mayenne North, Mayenne, France

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 who received a bilateral lung transplantation

You may qualify if:

• Double lung transplant recipients
• Age 18 years or older at the time of transplant
• Transplant between January 1, 2010 and December 31, 2020
• At least 2 PFTs available for analysis

You may not qualify if:

• Did not consent to clinical data use for research purposes
• Multi-organ transplant

Sponsors & Collaborators

• Paris Translational Research Center for Organ Transplantation: lead

Study Sites (1)

Foch hospital

Suresnes, France

Location

Related Publications (4)

• GBD Chronic Respiratory Disease Collaborators. Prevalence and attributable health burden of chronic respiratory diseases, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Respir Med. 2020 Jun;8(6):585-596. doi: 10.1016/S2213-2600(20)30105-3.

  PMID: 32526187 BACKGROUND

• Li X, Cao X, Guo M, Xie M, Liu X. Trends and risk factors of mortality and disability adjusted life years for chronic respiratory diseases from 1990 to 2017: systematic analysis for the Global Burden of Disease Study 2017. BMJ. 2020 Feb 19;368:m234. doi: 10.1136/bmj.m234.

  PMID: 32075787 BACKGROUND

• Brakema EA, Tabyshova A, van der Kleij RMJJ, Sooronbaev T, Lionis C, Anastasaki M, An PL, Nguyen LT, Kirenga B, Walusimbi S, Postma MJ, Chavannes NH, van Boven JFM; FRESH AIR collaborators. The socioeconomic burden of chronic lung disease in low-resource settings across the globe - an observational FRESH AIR study. Respir Res. 2019 Dec 21;20(1):291. doi: 10.1186/s12931-019-1255-z.

  PMID: 31864411 BACKGROUND

• Perch M, Hayes D Jr, Cherikh WS, Zuckermann A, Harhay MO, Hsich E, Potena L, Sadavarte A, Lindblad K, Singh TP, Stehlik J; International Society for Heart and Lung Transplantation. The International Thoracic Organ Transplant Registry of the International Society for Heart and Lung Transplantation: Thirty-ninth adult lung transplantation report-2022; focus on lung transplant recipients with chronic obstructive pulmonary disease. J Heart Lung Transplant. 2022 Oct;41(10):1335-1347. doi: 10.1016/j.healun.2022.08.007. Epub 2022 Aug 20. No abstract available.

  PMID: 36050206 BACKGROUND

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Antoine Roux, MD, PhD

  Foch hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 7, 2023
• Study Start: January 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: July 1, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After publication
• Access Criteria: Via email to the corresponding author

Locations

FR (1)