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

NCT03959579 | Completed

• 1 other identifier: 2017-28
• Study Type: observational
• Target: 269
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Long-term survival

  Survival of patients

  15 years

Secondary Outcomes (4)

• Sensitivity

  15 years

• Specificity

  15 years

• Positive Predictive Value

  15 years

• Negative Predictive Value

  15 years

Other Outcomes (1)

• Incidence of long-term complications

  15 years

Study Arms (2)

1st cohort = "derivation cohort":

1st cohort = "derivation cohort": 1990-1998: cardiac echo + simultaneous systematic endomyocardial biopsy

Diagnostic Test: systematic endomyocardial biopsy.

2nd cohort = "validation cohort"

2nd cohort = "validation cohort": 1999-2016: only cardiac echo with same protocol (endomyocardial biopsy only in case of doubt)

Interventions

systematic endomyocardial biopsy. DIAGNOSTIC_TEST

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

1st cohort = "derivation cohort":

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

269 patients (alive and deceased) patients transplanted between 1990 and 1998 and 1999 and 2016

You may qualify if:

• All heart transplant patients, including heart / liver and heart / kidney, and followed at Marie Lannelongue Hospital
• Transplantations carried out between 01/01/1990 and 31/12/2006
• Major and minor patients

You may not qualify if:

• Patient with missing test data (cardiac ultrasound or endomyocardial biopsy)
• Patient who did not simultaneously benefit from cardiac ultrasound and endomyocardial biopsy (Delayed period of +/- 1 days)
• Patient who had an endomyocardial biopsy without cardiac ultrasound the day before or the day after endomyocardial biopsy.

Sponsors & Collaborators

• Centre Chirurgical Marie Lannelongue: lead

Study Sites (1)

Hopital Marie Lannelongue

Le Plessis-Robinson, 92350, France

Location

Study Officials

• Julien Guihaire, MD, PhD

  Marie Lannelongue Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2018
• First Posted: May 22, 2019
• Study Start: November 22, 2017
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: May 22, 2019

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)