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The "no Biopsy Approach" for Heart Transplantation Follow-up
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Cardiac Transplant Rejection | Diagnostic Test: systematic endomyocardial biopsy. |
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 Type : | Observational |
| Actual Enrollment : | 269 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Long-term Outcomes After Non-invasive Assessment of Acute Cardiac Rejection in Heart Transplantation : the Marie Lannelongue Hospital Experience |
| Actual Study Start Date : | November 22, 2017 |
| Actual Primary Completion Date : | March 31, 2018 |
| Actual Study Completion Date : | March 31, 2018 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
1st cohort = "derivation cohort":
1st cohort = "derivation cohort": 1990-1998: cardiac echo + simultaneous systematic endomyocardial biopsy
|
Diagnostic Test: 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 |
|
2nd cohort = "validation cohort"
2nd cohort = "validation cohort": 1999-2016: only cardiac echo with same protocol (endomyocardial biopsy only in case of doubt)
|
- Long-term survival [ Time Frame: 15 years ]Survival of patients
- Sensitivity [ Time Frame: 15 years ]Sensitivity of Cardiac Ultrasound to Diagnose Acute Heart Releases in the 1st Group
- Specificity [ Time Frame: 15 years ]Specificity of Cardiac Ultrasound to Diagnose Acute Heart Releases in the 1st Group
- Positive Predictive Value [ Time Frame: 15 years ]Positive Predictive Value of Cardiac Ultrasound to Diagnose Acute Heart Releases in the 1st Group
- Negative Predictive Value [ Time Frame: 15 years ]Negative Predictive Value of Cardiac Ultrasound to Diagnose Acute Heart Releases in the 1st Group
- Incidence of long-term complications [ Time Frame: 15 years ]Incidence of chronic cardiac rejection (coronary disease of the graft), retransplantation rate
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
| France | |
| Hopital Marie Lannelongue | |
| Le Plessis-Robinson, France, 92350 | |
| Principal Investigator: | Julien Guihaire, MD, PhD | Marie Lannelongue Hospital |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 4, 2018 | ||||
| First Posted Date | May 22, 2019 | ||||
| Last Update Posted Date | May 22, 2019 | ||||
| Actual Study Start Date | November 22, 2017 | ||||
| Actual Primary Completion Date | March 31, 2018 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Long-term survival [ Time Frame: 15 years ] Survival of patients
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
|
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures |
Incidence of long-term complications [ Time Frame: 15 years ] Incidence of chronic cardiac rejection (coronary disease of the graft), retransplantation rate
|
||||
| Original Other Pre-specified Outcome Measures | Same as current | ||||
| Descriptive Information | |||||
| Brief Title | The "no Biopsy Approach" for Heart Transplantation Follow-up | ||||
| Official Title | Long-term Outcomes After Non-invasive Assessment of Acute Cardiac Rejection in Heart Transplantation : the Marie Lannelongue Hospital Experience | ||||
| Brief 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. 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. |
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| 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. |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | 269 patients (alive and deceased) patients transplanted between 1990 and 1998 and 1999 and 2016 | ||||
| Condition | Cardiac Transplant Rejection | ||||
| Intervention | Diagnostic Test: 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 |
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
269 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | March 31, 2018 | ||||
| Actual Primary Completion Date | March 31, 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03959579 | ||||
| Other Study ID Numbers | 2017-28 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Centre Chirurgical Marie Lannelongue | ||||
| Study Sponsor | Centre Chirurgical Marie Lannelongue | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Centre Chirurgical Marie Lannelongue | ||||
| Verification Date | May 2018 | ||||
