HEart trAnsplantation Registry of piTie-Salpetriere University Hospital

NCT03393793 | Completed

• 1 other identifier: CIC1421-18-01
• Study Type: observational
• Target: 566
• Locations: 0 countries
• Sites: N/A

Brief Summary

Heart transplantation (HTx) is a procedure which is hindered by several complications. The HEARTS registry aims to allow the analysis of risk factors of all post-HTx complications. It consists in an exhaustive data collection at the moment of inclusion, i.e. HTx, knowing that patients underwent a full-fledged evaluation beforehand to evaluate their aptitude to being transplanted. Post-HTx complications include but is not limited to: all-cause mortality, AMR, ACR, CAV, AKI, sepsis, cancer, psychological disorders, metabolic disorders.

Conditions

Cardiac Transplant Disorder; Cardiac Death; Heart Failure; Acute Cellular Graft Rejection; Antibody-Mediated Graft Rejection; Cardiac Allograft Vasculopathy; Heart Transplant Rejection; Immune Tolerance

Keywords

Heart transplantation

Outcome Measures

Primary Outcomes (6)

• All-cause mortality

  all-cause mortality

  up to five years after inclusion

• Acute cellular rejection (ACR)

  ACR, biopsy-proven

  up to five years after inclusion

• Antibody mediated rejection (AMR)

  AMR, biopsy-proven

  up to five years after inclusion

• Acute kidney injury (AKI)

  AKI, defined by a KDIGO criteria

  up to five years after inclusion

• Severe sepsis or septic shock

  As defined by Surviving Sepsis Campaign

  up to five years after inclusion

• Cardiac allograft vasculopathy (CAV)

  CAV, defined ISHLT

  up to five years after inclusion

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who underwent heart transplantation were included in this cohort.

You may qualify if:

• Heart transplantation

You may not qualify if:

• None

Sponsors & Collaborators

• Lee S Nguyen: lead

Related Publications (2)

• 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.

  PMID: 30687469 BACKGROUND

• 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.

  PMID: 30286278 RESULT

MeSH Terms

Conditions

Death; Heart Failure

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Study Officials

• Shaida Varnous, MD

  AP-HP, Pitié Salpétrière, Paris, France

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 3, 2018
• First Posted: January 9, 2018
• Study Start: January 1, 2009
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2017
• Last Updated: September 26, 2019

Record last verified: 2019-09