Development Of Non-invasive Cell-free DNA To Supplant Invasive Biopsy In Heart Transplantation
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 22-007194
NCT ID: NCT05309382
Sponsor Protocol Number: 22-062-TRP
About this study
The purpose of this study is to describe the association between Prospera dd-cfDNA measures and other diagnostic tests used to detect heart allograft rejection and/or njury, including histology, echocardiography and DSA, in the first post-transplant year. Additionally, to inform rates of clinical outcomes in a contemporary cohort of adult heart transplant recipients to determine power for a future randomized, controlled clinical trial.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age 18 years or older at the time of signing informed consent.
- Undergoing transplant evaluation or currently on the heart transplant waiting list and expected to receive a heart transplant.
- Able to read, understand, and provide written informed consent.
- Able and willing to comply with the study visit schedule, study procedures, and study requirements.
Exclusion Criteria:
- Concurrent multiple solid organ or tissue transplants.
- Prior history of any organ or cellular transplantation.
- Pregnant.
Eligibility last updated 7/8/22. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Jose Nativi Nicolau, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available