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HeartCare for Heart Transplant Rejection (SHORE Trial)

N/A
Waitlist Available
Led By Jeffrey Teuteberg
Research Sponsored by CareDx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up dec-2026
Awards & highlights

Summary

This is an observational registry to assess the clinical utility of surveillance using HeartCare testing services, in association with clinical care of heart transplant recipients.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~dec-2026
This trial's timeline: 3 weeks for screening, Varies for treatment, and dec-2026 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of patients who develop de-novo DSA as a surrogate to clinical outcomes at 1, 3 and 5 years post-transplant.

Side effects data

From 2016 Phase 4 trial • 8 Patients • NCT01833897
38%
sedation
25%
headache
13%
phosphenes
13%
hypomania
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ketamine and DCS Treatment

Trial Design

2Treatment groups
Experimental Treatment
Group I: HeartCareExperimental Treatment1 Intervention
Diagnostic Test: Heart Care 2300 patients managed with HeartCare (AlloMap® and AlloSure-Heart® )
Group II: ControlExperimental Treatment1 Intervention
A historical control group will be matched to the estimated 1150 HeartCare group patients who complete at least two years of HeartCare surveillance use and inclusive of year 3 post-transplant clinical follow-up for outcome. The criteria for the matched controls will be based on allograft donor type, age, gender, ethnicity/race, and other clinical factors. Propensity scores will be used to perform the matching.

Find a Location

Who is running the clinical trial?

CareDxLead Sponsor
25 Previous Clinical Trials
12,701 Total Patients Enrolled
James P Yee, MD, PhDStudy DirectorCareDx
1 Previous Clinical Trials
2,444 Total Patients Enrolled
Sham DholakiaStudy DirectorCareDx
2 Previous Clinical Trials
748 Total Patients Enrolled
~730 spots leftby Nov 2026
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