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The "no Biopsy Approach" for Heart Transplantation Follow-up

NCT03959579 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 269

Last updated 2019-05-22

No results posted yet for this study

Summary

Pathological analysis is the gold standard for diagnosis of acute allograft rejection after heart transplantation (HTx). This method requires repeated endomyocardial biopsies during the first post-operative year. However the sensitivity of endomyocardial biopsy (EMB) is not perfect and can be associated with major complications including fatal tamponade. Moreover, repeated biopsies are associated with reduced quality of life for HTx recipients.

Since almost 20 years, the investigators do not perform routinely EMB for acute rejection screening. Early left ventricular diastolic dysfunction was investigated according to a standardized protocol. The investigators sought to analyze the long-term post-transplant outcomes without systematic EMB. The investigators hypothesize that exclusive echographic screening was not associated with impaired outcomes.

Conditions

  • Cardiac Transplant Rejection

Interventions

DIAGNOSTIC_TEST

systematic endomyocardial biopsy.

We sought to compare the long term survival of HTx recipients followed with or without systematic endomyocardial biopsy. Second, the sensibility and specificity of cardiac echo to diagnose acute allograft rejection will be analyzed. To show the safety of non-invasively monitoring HTx recipients without systematic endomyocardial biopsy

Sponsors & Collaborators

  • Centre Chirurgical Marie Lannelongue

    lead OTHER

Principal Investigators

  • Julien Guihaire, MD, PhD · Marie Lannelongue Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-22
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • France

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 NCT03959579 on ClinicalTrials.gov