Trajectories of Cardiac Allograft Vasculopathy After Heart Transplantation

Heart Transplantation Clinical Trial

— TRAJ-CAV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04117152
• Other study ID #: ParisTRCOT_CAV
• Status: Completed
• Start date: January 1, 2004
• Est. completion date: June 2020

Study information

• Verified date: September 2020
• Source: Paris Translational Research Center for Organ Transplantation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1300
• Est. completion date: June 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Allograft Arteriopathy
• Heart Transplantation
• Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
Belgium	Maarten Naesens	Leuven
France	Paris Transplant Group	Paris
United States	Jon Kobashigawa	Los Angeles	California

Sponsors (5)

Lead Sponsor	Collaborator
Paris Translational Research Center for Organ Transplantation	Cedars-Sinai Medical Center, European Georges Pompidou Hospital, Groupe Hospitalier Pitie-Salpetriere, Universitaire Ziekenhuizen Leuven

Countries where clinical trial is conducted

United States,  Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of trajectories of Cardiac Allograft Vasculopathy (CAV)	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.	10 years post-transplant
Secondary	Identification of the specific determinants of CAV trajectories	Identification of immune and non-immune determinants using multivariable multinomial logistic regression.	From transplantation to 1-year post-transplant
Secondary	Early prediction of CAV trajectories	Probability of belonging to each trajectory according to the baseline angiogram and independent risk factors for CAV	10 years post-transplant
Secondary	Patients and allograft survival probability according the CAV trajectory	Comparison of prognosis according the CAV trajectory	10 years post-transplant