Heart Transplant Clinical Trials

Clinical trials related to Heart Transplant Procedure

Predictive Modeling of Acute Rejection in Pediatric Heart Transplant Recipients

Status: Recruiting
Location: See all (22) locations...
Study Type: Observational
SUMMARY

Acute rejection remains a major cause of morbidity and mortality in pediatric patients after heart transplant. In order to screen for rejection, most centers perform heart catheterizations with endomyocardial biopsies frequently in the first year post transplant and then every 1-2 years thereafter; these biopsies are associated with complications, can cause significant anxiety in patients and family members, and are a significant cost for the healthcare system. This project will evaluate non-invasive methods of detecting rejection using cardiac magnetic resonance imaging and blood testing with a goal to reduce the required number of cardiac catheterizations.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 25
Healthy Volunteers: f
View:

• Received heart transplant at age \< 21 years old

• \> 2 months from transplant

• ≥6 years old and ≤ 25 years old and able to undergo cardiac MRI (CMR)

• CMR can be scheduled within 5 days from heart biopsy\*

• Heart catheterization with biopsy is scheduled for cause to confirm suspected AR or Heart catheterization with biopsy is scheduled for surveillance

Locations
United States
Arkansas
Arkansas Children's Hospital
RECRUITING
Little Rock
California
Children's Hospital of Los Angeles
RECRUITING
Los Angeles
UCLA
RECRUITING
Los Angeles
Lucile Packard Children's Hospital at Stanford
RECRUITING
Palo Alto
Rady Children's Hospital
RECRUITING
San Diego
Colorado
Children's Hospital Colorado
RECRUITING
Denver
Florida
University of Florida
RECRUITING
Gainesville
Joe DiMaggio Children's Hospital
RECRUITING
Hollywood
Georgia
Children's Hospital of Atlanta
RECRUITING
Atlanta
Illinois
Lurie Children's Hospital
RECRUITING
Chicago
Indiana
Riley Children's Hospital
RECRUITING
Indianapolis
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Michigan
University of Michigan
RECRUITING
Ann Arbor
Missouri
Washington University
RECRUITING
St Louis
New York
Columbia University
RECRUITING
New York
Mount Sinai Kravis Children's Hospital
RECRUITING
New York
Ohio
Nationwide Children's Hospital
RECRUITING
Columbus
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
Texas Children's Hospital
RECRUITING
Houston
UT Health Houston
RECRUITING
Houston
Washington
Seattle Children's Hospital
RECRUITING
Seattle
Wisconsin
Medical College of Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Jonathan Soslow, MD MSCI
PEACE@vumc.org
615-322-7447
Time Frame
Start Date: 2023-03-29
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 200
Treatments
Healthy pediatric heart transplant recipients
Pediatric heart transplant recipients not having rejection
Pediatric heart transplant recipients with acute rejection
Pediatric heart transplant recipients with acute rejection (ACR or AMR) as defined by the the core pathologist.
Healthy controls
Healthy control patients retrospectively enrolled at each site to standardize parametric mapping.
Related Therapeutic Areas
Sponsors
Leads: Vanderbilt University Medical Center
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov