Cardiac Transplant RejectionNCT03959579
The "no Biopsy Approach" for Heart Transplantation Follow-up
An observational study of Cardiac Transplant Rejection, run by Centre Chirurgical Marie Lannelongue at 1 site in France.
Trial summary
Pathological analysis is the gold standard for diagnosis of acute allograft rejection after heart transplantation (HTx). This method requires repeated endomyocardial biopsies during the first post-operative year. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Transplant Rejection
- What is being tested?
- systematic endomyocardial biopsy.
- How many people
- 269 participants
- Where
- 1 siteFrance
- Study dates
- 22 Nov 2017to 31 Mar 2018
- 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
- Child, Adult, Older adult
Study population: 269 patients (alive and deceased) patients transplanted between 1990 and 1998 and 1999 and 2016
Who may be able to join
- All heart transplant patients, including heart / liver and heart / kidney, and followed at Marie Lannelongue Hospital
- Transplantations carried out between 01/01/1990 and 31/12/2006
- Major and minor patients
Who cannot join
- Patient with missing test data (cardiac ultrasound or endomyocardial biopsy)
- Patient who did not simultaneously benefit from cardiac ultrasound and endomyocardial biopsy (Delayed period of +/- 1 days)
- Patient who had an endomyocardial biopsy without cardiac ultrasound the day before or the day after endomyocardial biopsy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Outcomes After Non-invasive Assessment of Acute Cardiac Rejection in Heart Transplantation : the Marie Lannelongue Hospital Experience
Pathological analysis is the gold standard for diagnosis of acute allograft rejection after heart transplantation (HTx). This method requires repeated endomyocardial biopsies during the first post-operative year. However the sensitivity of endomyocardial biopsy (EMB) is not perfect and can be associated with major complications including fatal tamponade. Moreover, repeated biopsies are associated with reduced quality of life for HTx recipients.
Since almost 20 years, the investigators do not perform routinely EMB for acute rejection screening. Early left ventricular diastolic dysfunction was investigated according to a standardized protocol. The investigators sought to analyze the long-term post-transplant outcomes without systematic EMB. The investigators hypothesize that exclusive echographic screening was not associated with impaired outcomes.
Read the detailed description
Demographic characteristics of heart transplant recipients and organ donors were prospectively collected in a local database. All HTx successively performed in the Hospital Marie Lannelongue from 1990 to 2016 were included. From 1990 to 1997, both EMB and cardiac echo were routinely performed at each medical follow-up date. After 1997, only cardiac echo was used to detect early acute allograft rejection. The investigators collected the results of all EMB and synchronous cardiac echo in patients transplanted between 1990 and 1997 (group A, validation cohort), and clinical events and long-term survival in patients transplanted from 1998 to 2016 (group B, standardization cohort). For our purpose, the investigators graded the histological patterns of acute cardiac rejection according to the 1990 international classification. Cardiac echo assessment included the isovolumic relaxation time, E-wave velocity and E/A ratio. Impaired left ventricular relaxation was consistent with acute cardiac rejection.
The investigators therefore analyzed the rate of positive and negative EMB during the first post-transplant year and compared these results to the synchronous cardiac echo report in group A. Sensibility and specificity of cardiac echo to detect acute cardiac rejection were calculated. The rate of acute cardiac rejection during the first year was collected in group B and compared to group A. Finally, long-term survival was analyzed according to the Kaplan-Meier approach and compared between group A and B (log-rank test). The investigators hypothesize that the participant will not observe any differences between groups considering the rate of acute cardiac rejection during the first year. In addition, the investigators do not expect to find any significant difference in long-term survival between the two cohorts. These findings may have a major impact on HTx follow-up since systematic EMB could be replaced by a standardized cardiac echo protocol focusing on left ventricular wall relaxation. EMB should therefore only be indicated in case of acute allograft dysfunction without evidence of rejection on conventional cardiac echo.
- Conditions
- Cardiac Transplant Rejection
- Being tested
- systematic endomyocardial biopsy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
systematic endomyocardial biopsy.Diagnostic test
We sought to compare the long term survival of HTx recipients followed with or without systematic endomyocardial biopsy. Second, the sensibility and specificity of cardiac echo to diagnose acute allograft rejection will be analyzed.
To show the safety of non-invasively monitoring HTx recipients without systematic endomyocardial biopsy
| Study group | Role | What they receive |
|---|---|---|
| 1st cohort = "derivation cohort": | 1st cohort = "derivation cohort": 1990-1998: cardiac echo + simultaneous systematic endomyocardial biopsy Receives: Diagnostic Test: systematic endomyocardial biopsy. | |
| 2nd cohort = "validation cohort" | 2nd cohort = "validation cohort": 1999-2016: only cardiac echo with same protocol (endomyocardial biopsy only in case of doubt) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term survival
Survival of patients
Measured: 15 years
Secondary outcomes (4)
Sensitivity
Sensitivity of Cardiac Ultrasound to Diagnose Acute Heart Releases in the 1st Group
Measured: 15 years
Specificity
Specificity of Cardiac Ultrasound to Diagnose Acute Heart Releases in the 1st Group
Measured: 15 years
Positive Predictive Value
Positive Predictive Value of Cardiac Ultrasound to Diagnose Acute Heart Releases in the 1st Group
Measured: 15 years
Negative Predictive Value
Negative Predictive Value of Cardiac Ultrasound to Diagnose Acute Heart Releases in the 1st Group
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start22 Nov 2017
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Transplant RejectionStudies 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
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Chirurgical Marie Lannelongue
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien Guihaire, MD, PhD, Principal investigator, Marie Lannelongue Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959579
- Sponsor's protocol ID
- 2017-28
- Status last verified
- May 2018
- First submitted
- 4 May 2018
- Last updated
- 22 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes After Non-invasive Assessment of Acute Cardiac Rejection in Heart Transplantation : the Marie Lannelongue Hospital Experience
- ClinicalTrials.gov ID
- NCT03959579
- Acronym / sponsor ID
- 2017-28
- Conditions
- Cardiac Transplant Rejection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- Centre Chirurgical Marie LannelongueUniversity, hospital or other
- Study start
- 22 Nov 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 22 May 2019 (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.
Pathological analysis is the gold standard for diagnosis of acute allograft rejection after heart transplantation (HTx). This method requires repeated endomyocardial biopsies during the first post-operative year. However the sensitivity of endomyocardial biopsy (EMB) is not perfect and can be associated with major complications including fatal tamponade. Moreover, repeated biopsies are associated with reduced quality of life for HTx recipients.
Since almost 20 years, the investigators do not perform routinely EMB for acute rejection screening. Early left ventricular diastolic dysfunction was investigated according to a standardized protocol. The investigators sought to analyze the long-term post-transplant outcomes without systematic EMB. The investigators hypothesize that exclusive echographic screening was not associated with impaired outcomes.
Detailed description
Demographic characteristics of heart transplant recipients and organ donors were prospectively collected in a local database. All HTx successively performed in the Hospital Marie Lannelongue from 1990 to 2016 were included. From 1990 to 1997, both EMB and cardiac echo were routinely performed at each medical follow-up date. After 1997, only cardiac echo was used to detect early acute allograft rejection. The investigators collected the results of all EMB and synchronous cardiac echo in patients transplanted between 1990 and 1997 (group A, validation cohort), and clinical events and long-term survival in patients transplanted from 1998 to 2016 (group B, standardization cohort). For our purpose, the investigators graded the histological patterns of acute cardiac rejection according to the 1990 international classification. Cardiac echo assessment included the isovolumic relaxation time, E-wave velocity and E/A ratio. Impaired left ventricular relaxation was consistent with acute cardiac rejection.
The investigators therefore analyzed the rate of positive and negative EMB during the first post-transplant year and compared these results to the synchronous cardiac echo report in group A. Sensibility and specificity of cardiac echo to detect acute cardiac rejection were calculated. The rate of acute cardiac rejection during the first year was collected in group B and compared to group A. Finally, long-term survival was analyzed according to the Kaplan-Meier approach and compared between group A and B (log-rank test). The investigators hypothesize that the participant will not observe any differences between groups considering the rate of acute cardiac rejection during the first year. In addition, the investigators do not expect to find any significant difference in long-term survival between the two cohorts. These findings may have a major impact on HTx follow-up since systematic EMB could be replaced by a standardized cardiac echo protocol focusing on left ventricular wall relaxation. EMB should therefore only be indicated in case of acute allograft dysfunction without evidence of rejection on conventional cardiac echo.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1st cohort = "derivation cohort": | – | Diagnostic Test: systematic endomyocardial biopsy.1st cohort = "derivation cohort": 1990-1998: cardiac echo + simultaneous systematic endomyocardial biopsy |
| 2nd cohort = "validation cohort" | – | –2nd cohort = "validation cohort": 1999-2016: only cardiac echo with same protocol (endomyocardial biopsy only in case of doubt) |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 269 patients (alive and deceased) patients transplanted between 1990 and 1998 and 1999 and 2016
Key inclusion criteria (3 listed)
- All heart transplant patients, including heart / liver and heart / kidney, and followed at Marie Lannelongue Hospital
- Transplantations carried out between 01/01/1990 and 31/12/2006
- Major and minor patients
Key exclusion criteria (3 listed)
- Patient with missing test data (cardiac ultrasound or endomyocardial biopsy)
- Patient who did not simultaneously benefit from cardiac ultrasound and endomyocardial biopsy (Delayed period of +/- 1 days)
- Patient who had an endomyocardial biopsy without cardiac ultrasound the day before or the day after endomyocardial biopsy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| systematic endomyocardial biopsy.We sought to compare the long term survival of HTx recipients followed with or without systematic endomyocardial biopsy. Second, the sensibility and specificity of cardiac echo to diagnose acute allograft rejection will be analyzed. To show the safety of non-invasively monitoring HTx recipients without systematic endomyocardial biopsy | Diagnostic test | 1st cohort = "derivation cohort": |
Primary outcome
Long-term survival
Time frame: 15 years
Survival of patients
4 secondary outcomes
Sensitivity
Time frame: 15 years
Specificity
Time frame: 15 years
Positive Predictive Value
Time frame: 15 years
Negative Predictive Value
Time frame: 15 years
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 22 May 2019.
- Individual participant dataSharing planned: No
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Magnetic Resonance Elastography as a Method to Estimate Stiffness of Soft Tissues
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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.
Julien Guihaire, MD, PhD principal investigator
Marie Lannelongue Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Transplant Rejection, run by Centre Chirurgical Marie Lannelongue at 1 site in France.
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 3 inclusion and 3 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 22 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Long-term survival (time frame: 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2019.