Cardiac Transplant DisorderHEARTSNCT03393793
HEart trAnsplantation Registry of piTie-Salpetriere University Hospital
An observational study of Cardiac Transplant Disorder and Cardiac Death, run by Lee S Nguyen.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Transplant Disorder, Cardiac Death, Heart Failure
- How many people
- 566 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2009to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who underwent heart transplantation were included in this cohort.
Who may be able to join
- Heart transplantation
Who cannot join
- None
About this study
Official title: Heart Transplantation Registry of Pitié-Salpétrière 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.
Read the detailed 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.
- Conditions
- Cardiac Transplant Disorder, Cardiac Death, Heart Failure, Acute Cellular Graft Rejection, Antibody-Mediated Graft Rejection, Cardiac Allograft Vasculopathy
- Keywords
- Heart transplantation
- Medical subject headings
- Death, Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
all-cause mortality
Measured: up to five years after inclusion
Acute cellular rejection (ACR)
ACR, biopsy-proven
Measured: up to five years after inclusion
Antibody mediated rejection (AMR)
AMR, biopsy-proven
Measured: up to five years after inclusion
Acute kidney injury (AKI)
AKI, defined by a KDIGO criteria
Measured: up to five years after inclusion
Severe sepsis or septic shock
As defined by Surviving Sepsis Campaign
Measured: up to five years after inclusion
Cardiac allograft vasculopathy (CAV)
CAV, defined ISHLT
Measured: up to five years after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start1 Jan 2009
- Primary completion31 Dec 2015
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac Transplant DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 566 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lee S Nguyen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lee S Nguyen, Groupe Hospitalier Pitie-Salpetriere
- Investigators
- Shaida Varnous, MD, Study director, AP-HP, Pitié Salpétrière, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393793
- Sponsor's protocol ID
- CIC1421-18-01
- Acronym
- HEARTS
- Status last verified
- Sep 2019
- First submitted
- 3 Jan 2018
- Last updated
- 26 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30687469Nguyen 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.
PubMed 30286278
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Transplantation Registry of Pitié-Salpétrière University Hospital
- ClinicalTrials.gov ID
- NCT03393793
- Acronym / sponsor ID
- HEARTS / CIC1421-18-01
- Conditions
- Cardiac Transplant Disorder, Cardiac Death, Heart Failure, Acute Cellular Graft Rejection, Antibody-Mediated Graft Rejection, Cardiac Allograft Vasculopathy
- Keywords
- Heart transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 566 participants (actual)
- Lead sponsor
- Lee S NguyenUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 9 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who underwent heart transplantation were included in this cohort.
Key inclusion criteria (1 listed)
- Heart transplantation
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Background: PubMed 30687469Meng 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.
- Results publication: PubMed 30286278Nguyen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaida Varnous, MD study director
AP-HP, Pitié Salpétrière, Paris, France
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Transplant Disorder and Cardiac Death, run by Lee S Nguyen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: up to five years after inclusion). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03393793, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.