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Pediatric Heart TransplantationNCT02752789

Impact of Allo- and Autoantibodies on Chronic Cardiac Allograft Function

An observational study of Pediatric Heart Transplantation and Pediatric Heart Transplant Recipients, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multi-center, prospective, single cohort, observational study of pediatric heart transplant recipients designed to determine the impact of preformed versus de novo human leukocyte antigen (HLA) donor-specific antibodies (DSA), and antibodies to the self-antigens cardiac myosin and vimentin, on chronic… Read more about this study

Who is it for?
Ages Up to 20 years
How many people
407 participants
Where
9 sitesin 2 countries
Study dates
15 Jul 2014to 1 Nov 2019
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 Up to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: Participants that were enrolled in CTOTC-04 (ClinicalTrials.gov ID NCT01005316) who consent to long-term follow-up and new participants at the nine designated sites who are listed for isolated orthotopic heart transplantation

Who may be able to join

  • Subject and/or parent guardian able to understand and provide informed consent and where applicable assent
  • Planned long-term follow-up at one of the study sites
  • AND either:
  • -Enrolled in the CTOTC-04 study and actively followed at one of the study sites
  • OR
  • -Listed at participating study sites, less than 21 years of age and not yet transplanted.
  • The inclusion criteria for enrollment of new study patients in the CTOTC-09 Protocol will be the same as the CTOTC-04 study (refer to ClinicalTrials.gov ID NCT01005316).

Who cannot join

  • Parental withdrawal of consent from the CTOTC-04 study
  • Past or current medical problems or findings from physical examination or laboratory testing that, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or may impact the quality or interpretation of the data obtained from the study
  • Listed for simultaneous multiple organ transplant.

Trial locations and contacts

9 sites in 2 countries.

9 sites in 2 countries

United States8 sites

  • Emory University School of Medicine

    Atlanta, Georgia, 30060

  • Children's Hospital Boston

    Boston, Massachusetts, 02115

  • Monroe Carell Jr. Children's Hospital

    Nashville, Tennessee, 37232

  • Columbia University Medical Center

    New York, New York, 10032

  • Children's Hospital at Montefiore

    New York, New York, 10467

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224

  • St. Louis Children's Hospital

    St Louis, Missouri, 63110

Other trials in United States

Canada1 site

  • Hospital for Sick Children

    Toronto, M5G 1X8

Other trials in Canada

About this study

Official title: An Observational Cohort Study to Determine the Impact of Alloantibodies and Antibodies to Self Antigens on Chronic Graft Function up to 5 Years After Pediatric Heart Transplantation (CTOTC-09)

This is a multi-center, prospective, single cohort, observational study of pediatric heart transplant recipients designed to determine the impact of preformed versus de novo human leukocyte antigen (HLA) donor-specific antibodies (DSA), and antibodies to the self-antigens cardiac myosin and vimentin, on chronic allograft function. In addition, the investigators will explore mechanisms of action and predictors of DSA, rejection and altered pathophysiology.

Read the detailed description

Participants that were enrolled in the CTOTC-04 study (ClinicalTrials.gov Identifier NCT01005316) are invited to enroll in this CTOTC-09 study. Conversion from the CTOTC-04 to CTOTC-09 study will occur in such a manner as to avoid/minimize discontinuity of follow-up between the planned CTOTC-04 and CTOTC-09 study visits. In addition, subjects added to the United Network for Organ Sharing (UNOS) system-or Canadian equivalent agency-at a participating study site, who are less than 21 years of age and fulfill all study eligibility criteria, will be invited to enroll in CTOTC-09.

This study focuses on the importance of antibodies against the newly transplanted heart in pediatric heart transplant recipients. The investigators aim to determine if certain antibodies lead to problems with the heart transplant. Antibodies are small proteins in the blood that the body makes to fight off infections, for example with bacteria or viruses. Since a new heart is "foreign" to the recipient's body, their immune system might try to attack it with antibodies, as if it were an infection. For many years it was thought that only white blood cells attacked the new heart, causing rejection.

Now there is new information showing that antibodies may also cause rejection or long-term damage to the heart. At this time, very little is known about how antibodies might cause problems after heart transplantation in transplant recipients younger than 21 years at the time of transplant.

This study will collect a medical history and blood samples at specified times for research. The blood samples will be used to measure antibodies in the blood, and to perform special tests to see how these antibodies might damage the heart.

Participant follow-up is from the day of the heart transplant to year 5 post-transplant.

Keywords
alloantibodies, donor specific antibodies (DSA)-preformed, de novo, self-antigens, chronic allograft function

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02752789
Study groupRoleWhat they receive
Pediatric Heart Transplant RecipientsCTOTC-04 (ClinicalTrials.gov ID NCT01005316) participants who consent to long-term follow-up as part of this study as well as candidates less than 21 years of age who are listed for isolated orthotopic heart transplantation at one of the participating sites

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pulmonary capillary wedge pressure at heart catheterization

    Measured: 3 years post-transplantation

Secondary outcomes (16)

  1. Other invasive cardiac hemodynamic findings at cardiac catheterization

    Cardiac hemodynamic findings: right and left ventricular end diastolic pressures, right atrial pressure, pulmonary artery pressure and cardiac index

    Measured: 3 and 5 years post-transplantation

  2. Frequency of development of post-transplant de novo DSA and autoantibodies to cardiac myosin and vimentin

    Measured: 3 years post-transplantation

  3. Time course of development of post-transplant de novo DSA and autoantibodies to cardiac myosin and vimentin.

    Measured: 3 years post-transplantation

  4. Frequency of first episode of late acute rejection

    Measured: From >1 year to 5 years post-transplantation

  5. Time to first episode of late acute rejection

    Late acute rejection is defined as occurring >1 year post-transplantation

    Measured: From >1 year to 5 years post-transplantation

  6. Frequency to recurrent (two or more) late acute rejections

    Measured: Up to 5 years post-transplantation

  7. Time to recurrent late acute rejections

    Recurrent defined as two or more late acute rejection episodes

    Measured: Up to 5 years post-transplantation

  8. Frequency to first episode of late acute rejection with hemodynamic compromise

    Measured: Up to 5 years post-transplantation

  9. Time to first episode of late acute rejection with hemodynamic compromise

    Measured: Up to 5 years post-transplantation

  10. Time to graft loss (death or retransplantation) conditional to surviving one year post-transplantation

    Measured: One year and up to 5 years post-transplantation

  11. N-terminal pro-brain Natriuretic Peptide (NT-proBNP)/Brain Natriuretic Peptide (BNP)

    Measured: 3 and 5 years post-transplantation

  12. Systolic and diastolic graft function

    Graft function as assessed by echocardiography

    Measured: 3 and 5 years

  13. Proportion of participants with angiographic evidence of coronary artery disease

    Measured: 3 and 5 years post-transplantation

  14. Time to graft loss (death or retransplantation) after first late rejection

    Measured: Up to 5 years post-transplantation

  15. Medication Adherence Measure (MAM) after hospital discharge

    Measured: Up to 5 years post-transplantation

  16. Variability of maintenance tacrolimus levels

    Measured: Up to 5 years post-transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2016 (estimated)
  2. Study start15 Jul 2014
  3. Primary completion1 Nov 2019
  4. Study completion1 Nov 2019

Resources

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
Prospective
Enrolment
407 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02752789
Sponsor's protocol ID
DAIT CTOTC-09
Status last verified
Nov 2019
First submitted
22 Apr 2016
Last updated
29 Nov 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Pediatric Heart Transplantation and Pediatric Heart Transplant Recipients, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 sites in 2 countries.

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 7 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 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States, Canada. 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?

Pulmonary capillary wedge pressure at heart catheterization (time frame: 3 years post-transplantation). 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 NCT02752789.

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 29 Nov 2019.

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