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Extracorporeal Photopheresis and Early Cardiac Graft Vasculopathy

NCT04226521 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2024-08-13

No results posted yet for this study

Summary

Heart transplantation is a golden standard for the treatment of terminal heart failure. The major cause of death in late posttransplant period is cardiac allograft vasculopathy (CAV). This posttransplant complication develops slowly over several years, and when diagnosed either by conventional coronary angiography or due to graft failure, it is often too advanced and difficult to treat since it is diffuse coronary artery disease.

Therefore, early prevention of CAV is a subject of major interest in the transplant cardiology. Since CAV is associated with immune factors, immunomodulatory therapeutic options, like extracorporeal photopheresis are lately being investigated.

Unlike conventional coronary angiography, optical coherence tomography (OCT) is able to detect the development of CAV in the earliest phase, i.e. even in the first post-transplant year.

In our study, we plan to investigate the prophylactic effect of extracorporeal photopheresis in the early development of cardiac graft vasculopathy detected by OCT.

Conditions

  • Cardiac Allograft Vasculopathy
  • Heart Transplant Rejection

Interventions

PROCEDURE

Extracoropreal photopheresis

Patients who sign informed consent form undergo prophylactic extracorporeal photopheresis after heart transplant according to predetermined protocol

Sponsors & Collaborators

  • University of Zagreb

    collaborator OTHER

  • Bosko Skoric

    lead OTHER

Principal Investigators

  • Boško Skorić · UHC Zagreb

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2023-10-17
Completion
2023-10-17

Countries

  • Croatia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04226521 on ClinicalTrials.gov