Orthotopic Heart TransplantationNCT00208884
Terminal Graft Failure
An observational study of Orthotopic Heart Transplantation and Graft Failure, run by Emory University at 1 site in United States.
Trial summary
One of the risks associated with heart transplantation is failure of the graft. A graft is where the new heart is attached to the original vessels in the body. Approximately 10% of children suffer graft failure which, leads to heart failure and possible death. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Orthotopic Heart Transplantation, Graft Failure
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Nov 2005
- 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
Who may be able to join
- retransplanted at Children's Healthcare of Atlanta for late graft failure
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
About this study
Official title: Terminal Graft Failure: A Combined Pathologic and Clinical Study
One of the risks associated with heart transplantation is failure of the graft. A graft is where the new heart is attached to the original vessels in the body. Approximately 10% of children suffer graft failure which, leads to heart failure and possible death. The problem is that we do not know some of the causes of graft failure thus, it is difficult to diagnose early and treat. Due to graft failure, lots of children are placed back on the transplant list and receive another new heart.
In this study, we plan to perform a retrospective chart review looking to see if we can correlate graft failure with a problem with the vessels called coronary allograft vasculopathy or rejection. In order to do this, we will collect data from patient's charts that have been diagnosed with graft failure and compare their clinical presentation/data to pathology reports of the explanted hearts from these children. Explanted hearts are the old transplanted hearts that are removed in order to put a new heart into the body. Explanted hearts at our institution are always sent to pathology for analysis thus it will be quite easy to perform this review.
Read the detailed description
The objectives are to describe the pathology findings from the examination of the explanted heart and correlate them with clinical variables such as catheterization data.
Children's Healthcare of Atlanta performs approximately 12-15 heart transplants a year. To date, there have been 19 re-transplantations for late graft failure at Children's. The pathologic and clinical records of these 19 patients will be studied. All data collected will be entered into a database for future analysis.
Data Collection
A retrospective review of standard pathology findings from the examination of the explanted hearts will be conducted in order to determine the following:
- Evidence of CAV (coronary allograft vasculopathy)
- Evidence of Endocardial fibroelastosis
- Evidence of Rejection (acute and chronic)
- Evidence of Myocardial infarction
- Evidence of Fibrosis
- Evidence of Fatty infiltration
A retrospective review of patient charts will also be utilized to compare the pathologic findings to clinical data obtained prior to re-transplantation. The following information will be collected:
- Type of transplant method
- Patient age at time of transplant
- Echocardiographic Data including Tissue Doppler Imaging (if available)
- Catheterization data
- CAV as identified by coronary angiography
- Ventricular end-diastolic pressure
- Cardiac index
- Ventricular ejection fraction
- Clinical rejection history
- Conditions
- Orthotopic Heart Transplantation, Graft Failure
- Keywords
- pediatric, orthotopic heart transplantation, graft failure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startOct 2003
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthotopic Heart TransplantationStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Time perspective
- Retrospective
- Enrolment
- 19 participants
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William T. Mahle, MD, Emory University
- Investigators
- William Mahle, MD, Principal investigator, Emory University and Children's Healthcare of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00208884
- Sponsor's protocol ID
- 1001-2003
- Status last verified
- Nov 2013
- First submitted
- 13 Sep 2005
- Last updated
- 27 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Terminal Graft Failure: A Combined Pathologic and Clinical Study
- ClinicalTrials.gov ID
- NCT00208884
- Acronym / sponsor ID
- 1001-2003
- Conditions
- Orthotopic Heart Transplantation, Graft Failure
- Keywords
- pediatric, orthotopic heart transplantation, graft failure
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 19 participants
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Oct 2003
- Study completion
- Nov 2005
- First posted
- 21 Sep 2005 (estimated)
- 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.
One of the risks associated with heart transplantation is failure of the graft. A graft is where the new heart is attached to the original vessels in the body. Approximately 10% of children suffer graft failure which, leads to heart failure and possible death. The problem is that we do not know some of the causes of graft failure thus, it is difficult to diagnose early and treat. Due to graft failure, lots of children are placed back on the transplant list and receive another new heart.
In this study, we plan to perform a retrospective chart review looking to see if we can correlate graft failure with a problem with the vessels called coronary allograft vasculopathy or rejection. In order to do this, we will collect data from patient's charts that have been diagnosed with graft failure and compare their clinical presentation/data to pathology reports of the explanted hearts from these children. Explanted hearts are the old transplanted hearts that are removed in order to put a new heart into the body. Explanted hearts at our institution are always sent to pathology for analysis thus it will be quite easy to perform this review.
Detailed description
The objectives are to describe the pathology findings from the examination of the explanted heart and correlate them with clinical variables such as catheterization data.
Children's Healthcare of Atlanta performs approximately 12-15 heart transplants a year. To date, there have been 19 re-transplantations for late graft failure at Children's. The pathologic and clinical records of these 19 patients will be studied. All data collected will be entered into a database for future analysis.
Data Collection
A retrospective review of standard pathology findings from the examination of the explanted hearts will be conducted in order to determine the following:
- Evidence of CAV (coronary allograft vasculopathy)
- Evidence of Endocardial fibroelastosis
- Evidence of Rejection (acute and chronic)
- Evidence of Myocardial infarction
- Evidence of Fibrosis
- Evidence of Fatty infiltration
A retrospective review of patient charts will also be utilized to compare the pathologic findings to clinical data obtained prior to re-transplantation. The following information will be collected:
- Type of transplant method
- Patient age at time of transplant
- Echocardiographic Data including Tissue Doppler Imaging (if available)
- Catheterization data
- CAV as identified by coronary angiography
- Ventricular end-diastolic pressure
- Cardiac index
- Ventricular ejection fraction
- Clinical rejection history
Study design
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- retransplanted at Children's Healthcare of Atlanta for late graft failure
Key exclusion criteria (1 listed)
- -
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
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2013.
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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.
William Mahle, MD principal investigator
Emory University and Children's Healthcare of Atlanta
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 Orthotopic Heart Transplantation and Graft Failure, run by Emory University at 1 site in United States.
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: stopped early, as of the sponsor's last update on 27 Nov 2013. 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 United States. 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 was stopped early. Results are not available in the source record.
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.
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 27 Nov 2013.