HEart trAnsplantation Registry of piTie-Salpetriere University Hospital

Heart Failure Clinical Trial

— HEARTS  

Official title:

Heart Transplantation Registry of Pitié-Salpétrière University Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03393793
• Other study ID #: CIC1421-18-01
• Status: Completed
• Start date: January 1, 2009
• Est. completion date: December 31, 2017

Study information

• Verified date: September 2019
• Source: Groupe Hospitalier Pitie-Salpetriere
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 566
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Heart transplantation

Exclusion Criteria:

• None

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lee S Nguyen

References & 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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	all-cause mortality	up to five years after inclusion
Primary	Acute cellular rejection (ACR)	ACR, biopsy-proven	up to five years after inclusion
Primary	Antibody mediated rejection (AMR)	AMR, biopsy-proven	up to five years after inclusion
Primary	Acute kidney injury (AKI)	AKI, defined by a KDIGO criteria	up to five years after inclusion
Primary	Severe sepsis or septic shock	As defined by Surviving Sepsis Campaign	up to five years after inclusion
Primary	Cardiac allograft vasculopathy (CAV)	CAV, defined ISHLT	up to five years after inclusion