Heart Transplant RejectionTOGETHERNCT03833050
The TOGETHER Project - Heart
An observational study of Heart Transplant Rejection, run by Mayo Clinic at 3 sites in United States.
Trial summary
The researchers are trying to develop a way to measure the risk of transplant rejection with a blood test. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Transplant Rejection
- How many people
- 101 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Dec 2017to 22 Sep 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Heart Transplant recipients
Who may be able to join
- Patients who meet all of the following criteria are eligible for enrollment as study participants:
- Adult (≥18 years) solitary heart transplant recipient
- Patient is willing and able to provide informed written consent
Who cannot join
- Patients who meet any of these criteria are not eligible for enrollment as study participants:
- Adult (<18 years) heart transplant recipient
- Patient refusal to enroll in the studyc3. Any simultaneous heart and extra organ transplant, including pancreas, liver, lung, kidney, etc. Subjects who have had previous transplants may be included.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Mayo Clinic
Jacksonville, Florida, 32224
Mayo Clinic
Phoenix, Arizona, 85054
Mayo Clinic
Rochester, Minnesota, 559055
About this study
Official title: The TOGETHER Project - Transplant Organ Genomics to Help Prevent Rejection in Heart Transplant Recipients
The researchers are trying to develop a way to measure the risk of transplant rejection with a blood test.
Read the detailed description
The study will utilize peripheral blood assays collected at time points that are considered standard of care at most institutions. Subjects will have peripheral blood collected at 1 month, 3 months, 6 months, and 12 months after heart transplantation, as well as any for cause time points. These samples will then be used for purposes of developing an RNA-seq based peripheral blood assay in adult heart transplant recipients.
- Conditions
- Heart Transplant Rejection
- Keywords
- heart transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Heart Transplant Recipients | Heart Transplant Recipients meeting the criteria for enrollment and consented will be followed post transplant for 1 year after enrollment into the study. Blood samples will be obtained at their 1, 3, 6, 12 months and any for cause heart biopsy's obtained. There will be no active intervention for recipients that are enrolled. Results from the samples will not be obtained in real time. |
What is being measured
The primary outcome is the main question the study is designed to answer.
RNA-seq based peripheral blood assay in heart transplant recipients
Cases will be reviewed and a subset of the peripheral blood specimens will be sent to Mayo Clinic Laboratories for development of the RNA-seq signature. The number of specimens analyzed will be determined based on the incidence of rejection and the incidence of biopsies for cause needed to develop the signature.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start7 Dec 2017
- Primary completion22 Sep 2020
- Study completion22 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Transplant RejectionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naveen L. Pereira, Mayo Clinic
- Investigators
- Naveen Pereira, M.D., Principal investigator, Mayo ClinicMark D Stegall, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03833050
- Sponsor's protocol ID
- 17-000682
- Acronym
- TOGETHER
- Status last verified
- Jun 2022
- First submitted
- 5 Feb 2019
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The TOGETHER Project - Transplant Organ Genomics to Help Prevent Rejection in Heart Transplant Recipients
- ClinicalTrials.gov ID
- NCT03833050
- Acronym / sponsor ID
- TOGETHER / 17-000682
- Conditions
- Heart Transplant Rejection
- Keywords
- heart transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 7 Dec 2017 (actual)
- Primary completion
- 22 Sep 2020 (actual)
- Study completion
- 22 Sep 2020 (actual)
- First posted
- 6 Feb 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.
The researchers are trying to develop a way to measure the risk of transplant rejection with a blood test.
Detailed description
The study will utilize peripheral blood assays collected at time points that are considered standard of care at most institutions. Subjects will have peripheral blood collected at 1 month, 3 months, 6 months, and 12 months after heart transplantation, as well as any for cause time points. These samples will then be used for purposes of developing an RNA-seq based peripheral blood assay in adult heart transplant recipients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Transplant Recipients | – | –Heart Transplant Recipients meeting the criteria for enrollment and consented will be followed post transplant for 1 year after enrollment into the study. Blood samples will be obtained at their 1, 3, 6, 12 months and any for cause heart biopsy's obtained. There will be no active intervention for recipients that are enrolled. Results from the samples will not be obtained in real time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart Transplant recipients
Key inclusion criteria (3 listed)
- Patients who meet all of the following criteria are eligible for enrollment as study participants:
- Adult (≥18 years) solitary heart transplant recipient
- Patient is willing and able to provide informed written consent
Key exclusion criteria (3 listed)
- Patients who meet any of these criteria are not eligible for enrollment as study participants:
- Adult (<18 years) heart transplant recipient
- Patient refusal to enroll in the studyc3. Any simultaneous heart and extra organ transplant, including pancreas, liver, lung, kidney, etc. Subjects who have had previous transplants may be included.
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
RNA-seq based peripheral blood assay in heart transplant recipients
Time frame: 3 years
Cases will be reviewed and a subset of the peripheral blood specimens will be sent to Mayo Clinic Laboratories for development of the RNA-seq signature. The number of specimens analyzed will be determined based on the incidence of rejection and the incidence of biopsies for cause needed to develop the signature.
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 14 Jun 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Heart Transplant Rejection
Enrolling by invitationObservational study
Donor Derived Cell Free DNA (Dd-cfDNA) as a Biomarker for Allograft Rejection in Heart Transplant Recipients
Heart Transplantation
RecruitingObservational study
Magnetic Resonance Elastography as a Method to Estimate Stiffness of Soft Tissues
Heart Failure, Liver Fibrosis
RecruitingObservational study
Trifecta-Heart cfDNA-MMDx Study
Heart Transplant Rejection
RecruitingPhase 2/3
Valganciclovir vs. Letermovir for CMV Prophylaxis in Heart Transplant
CMV Viremia, Heart Transplant Infection
RecruitingPhase 1/2
Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Prevent Rejection in Heart Transplant Children
Heart Transplantation
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.
Naveen Pereira, M.D. principal investigator
Mayo Clinic
Mark D Stegall, M.D. principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Transplant Rejection, run by Mayo Clinic at 3 sites 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 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 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 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?
RNA-seq based peripheral blood assay in heart transplant recipients (time frame: 3 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 14 Jun 2022.