HEart trAnsplantation Registry of piTie-Salpetriere University Hospital
NCT ID: NCT03393793
Last Updated: 2019-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
566 participants
OBSERVATIONAL
2009-01-01
2017-12-31
Brief Summary
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Post-HTx complications include but is not limited to: all-cause mortality, AMR, ACR, CAV, AKI, sepsis, cancer, psychological disorders, metabolic disorders.
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Detailed Description
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Post-HTx complications include but is not limited to: all-cause mortality, AMR, ACR, CAV, AKI, sepsis, cancer, psychological disorders, metabolic disorders.
To do so, patients are routinely monitored several times per year, the frequency of which depends on the proximity to the HTx.
An endomyocardial biopsy is performed 3 times per month starting on day 15 until day 65 after HTx, then once every 20 days until four months, then monthly until six months, then once every 45 days until year 1, and every 3 months thereafter until year 2. Afterwards, they become twice per year until year 5, then once a year.
An echocardiography is performed for every visit, with a complete blood analysis, including HLA antibodies screening with DSA evaluation, virologic evaluation.
A coronarography is performed for the anniversary year of HTx, then once every 2 years.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Lee S Nguyen
OTHER
Responsible Party
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Lee S Nguyen
Principal Investigator
Principal Investigators
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Shaida Varnous, MD
Role: STUDY_DIRECTOR
AP-HP, Pitié Salpétrière, Paris, France
References
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Meng P, Nguyen LS, Jabbour F, Ogna A, Clair B, Orlikowski D, Annane D, Lofaso F, Fayssoil A. Accuracy of B-natriuretic peptide for the diagnosis of decompensated heart failure in muscular dystrophies patients with chronic respiratory failure. Neurol Int. 2018 Dec 20;10(4):7917. doi: 10.4081/ni.2018.7917. eCollection 2018 Dec 5.
Nguyen LS, Coutance G, Salem JE, Ouldamar S, Lebreton G, Combes A, Amour J, Laali M, Leprince P, Varnous S. Effect of recipient gender and donor-specific antibodies on antibody-mediated rejection after heart transplantation. Am J Transplant. 2019 Apr;19(4):1160-1167. doi: 10.1111/ajt.15133. Epub 2018 Oct 29.
Other Identifiers
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CIC1421-18-01
Identifier Type: -
Identifier Source: org_study_id
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