HEart trAnsplantation Registry of piTie-Salpetriere University Hospital

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.

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Key information

Conditions

Cardiac Transplant Disorder Acute Cellular Graft Rejection Antibody-Mediated Graft Rejection Cardiac Allograft Vasculopathy Cardiac Death Cardiovascular Diseases Death Heart Diseases Heart Failure Heart Transplant Rejection Immune Tolerance Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Heart transplantation

Exclusion criteria

None

Treatment and study plan

Primary outcomes

All-cause mortality

Time frame: up to five years after inclusion

all-cause mortality
Acute cellular rejection (ACR)

Time frame: up to five years after inclusion

ACR, biopsy-proven
Antibody mediated rejection (AMR)

Time frame: up to five years after inclusion

AMR, biopsy-proven
Acute kidney injury (AKI)

Time frame: up to five years after inclusion

AKI, defined by a KDIGO criteria
Severe sepsis or septic shock

Time frame: up to five years after inclusion

As defined by Surviving Sepsis Campaign
Cardiac allograft vasculopathy (CAV)

Time frame: up to five years after inclusion

CAV, defined ISHLT

Sponsors and collaborators

Lead sponsor

Lee S Nguyen

Other

Registry information

Official study title

Heart Transplantation Registry of Pitié-Salpétrière University Hospital

Acronym: HEARTS

Important dates

Study start: 2009
Primary completion: 2015
Study completion: 2017
First posted: Jan 9, 2018
Registry last updated: Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed