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Trajectories of Cardiac Allograft Vasculopathy After Heart Transplantation (TRAJ-CAV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04117152
Recruitment Status : Completed
First Posted : October 7, 2019
Last Update Posted : September 16, 2020
Sponsor:
Collaborators:
Groupe Hospitalier Pitie-Salpetriere
European Georges Pompidou Hospital
Universitaire Ziekenhuizen Leuven
Cedars-Sinai Medical Center
Information provided by (Responsible Party):
Paris Translational Research Center for Organ Transplantation

Brief Summary:
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.

Condition or disease Intervention/treatment
Heart Transplantation Allograft Arteriopathy Other: Latent class mixed modeling

Detailed Description:

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Multicenter International Observational Study to Identify Trajectories of Cardiac Allograft Vasculopathy After Heart Transplantation and Their Specific Determinants
Actual Study Start Date : January 1, 2004
Actual Primary Completion Date : May 2020
Actual Study Completion Date : June 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Latent class mixed modeling
    To identify CAV trajectories after heart transplantation using a contemporary unsupervised trajectory-based approach known as latent class mixed modeling


Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Heart recipients aged over 18 and of all genders recruited between 2004 and 2015 from European and North American centers, who had at least two coronary angiograms during follow-up.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04117152


Locations
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United States, California
Jon Kobashigawa
Los Angeles, California, United States, 90211
Belgium
Maarten Naesens
Leuven, Belgium
France
Paris Transplant Group
Paris, France, 75015
Sponsors and Collaborators
Paris Translational Research Center for Organ Transplantation
Groupe Hospitalier Pitie-Salpetriere
European Georges Pompidou Hospital
Universitaire Ziekenhuizen Leuven
Cedars-Sinai Medical Center
Investigators
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Principal Investigator: Alexandre Loupy, MD, PhD Paris Transplant Group
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Paris Translational Research Center for Organ Transplantation
ClinicalTrials.gov Identifier: NCT04117152    
Other Study ID Numbers: ParisTRCOT_CAV
First Posted: October 7, 2019    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases