Skip to main content
OpenTrials
Completed

NCT Number: NCT04117152

Trajectories of Cardiac Allograft Vasculopathy After Heart Transplantation

This project aims: i) to identify Cardiac Allograft Vasculopathy (CAV) trajectories after heat transplantation using latent class mixed modeling, ii) to characterize the global and specific determinants of different trajectories and iii) to provide an easily accessible tool to project individual probability of CAV trajectory belonging.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maarten Naesens, Leuven, Belgium

Loading trial locations.

About this study

Background:

Cardiac Allograft Vasculopathy (CAV) is the third cause of late mortality and the leading cause of late allograft dysfunction. The field of heart transplantation currently lacks longitudinal description of CAV profiles. Identifying relevant CAV trajectories, or evolution profiles, and their respective determinants is an unmet clinical need. CAV trajectories requires an additional level of understanding and characterization over the current paradigm. Understanding the mechanisms and clinical factors involved in the development of CAV will be useful to provide a more nuanced picture of disease progression, which may ultimately contribute to risk stratification and ultimately guiding the care of HTx patients.

Main Outcome(s) and Measure(s):

  • Identification of CAV trajectories after transplantation using an unsupervised latent class mixed modeling. CAV angiograms were recorded per center protocol for all patients after transplantation. CAV was graded according to the current ISHLT classification as CAV 0 (not significant), 1 (mild), 2 (moderate) and 3 (severe).
  • Determination of clinical, functional, structural, immunological factors associated with the trajectories. In the derivation cohort, the associations between CAV trajectories and clinical, histological, functional, and immunological parameters at the time of transplantation, during the first year and at one-year post-transplant were assessed using multinomial logistic regression.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Heart recipient with at least two coronary angiograms after heart transplantation,
  • Heart recipient over 18 years of age.

Exclusion criteria

  • Patient with < 2 coronary angiograms during follow-up

Treatment and study plan

Latent class mixed modeling

Other

To identify CAV trajectories after heart transplantation using a contemporary unsupervised trajectory-based approach known as latent class mixed modeling

Primary outcomes

  1. Identification of trajectories of Cardiac Allograft Vasculopathy (CAV)

    Time frame: 10 years post-transplant

    Identification of different evolutive profiles of CAV using latent classes mixed models. Each coronary angiogram was graded from 0 (no CAV) to 3 (severe CAV) according to ISHLT classification.

Secondary outcomes

  1. Identification of the specific determinants of CAV trajectories

    Time frame: From transplantation to 1-year post-transplant

    Identification of immune and non-immune determinants using multivariable multinomial logistic regression.

  2. Early prediction of CAV trajectories

    Time frame: 10 years post-transplant

    Probability of belonging to each trajectory according to the baseline angiogram and independent risk factors for CAV

  3. Patients and allograft survival probability according the CAV trajectory

    Time frame: 10 years post-transplant

    Comparison of prognosis according the CAV trajectory

Sponsors and collaborators

Lead sponsor

Paris Translational Research Center for Organ Transplantation

Other

Collaborators

  • Cedars-Sinai Medical Center
  • European Georges Pompidou Hospital
  • Groupe Hospitalier Pitie-Salpetriere
  • Universitaire Ziekenhuizen KU Leuven

Registry information

Official study title

Multicenter International Observational Study to Identify Trajectories of Cardiac Allograft Vasculopathy After Heart Transplantation and Their Specific Determinants

Acronym: TRAJ-CAV

Important dates

Study start
2004
Primary completion
2020
Study completion
2020
First posted
Oct 7, 2019
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.