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NCT03695601 · ClinicalTrials.gov registry record
Surveillance HeartCare® Outcomes Registry
A clinical trial of Heart Transplant Rejection, sponsored by CareDx.
- Active
- Registry status
- 2,743
- Enrollment target
- 20
- Study locations
NCT03695601: Active study of Heart Transplant Rejection, sponsored by CareDx.
NCT03695601 is a study of Heart Transplant Rejection that is active but no longer recruiting, run by CareDx. The registered enrollment target is 2,743 participants, above the 192-participant average among 5 other Heart Transplant Rejection trials with a reported enrollment target (1329% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03695601, a study of Heart Transplant Rejection, is active but no longer recruiting, sponsored by CareDx.
- ACTIVE NOT RECRUITING
- Registry status
- 2,743 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The primary endpoint of the study is the proportion of patients who develop de-novo DSA as a surrogate to clinical outcomes at 1, 3 and 5 years post-transplant. The overall incidence of de-novo DSA is between 10-20% in the first year and 10-15% each year subsequently.
Conditions Studied
Interventions
- OTHER Standard of Care
Study Locations (20)
California
- University of California San Diego - La Jolla
- Cedars-Sinai Medical Center - Los Angeles
- University of California, Los Angeles - Los Angeles
- University of Southern California - Los Angeles
- California Pacific Medical Center - San Francisco
- University of California San Fransisco Medical Center - San Francisco
- Stanford University - Stanford
Florida
- Memorial Healthcare System - Hollywood
- Mayo Clinic- Florida - Jacksonville
- University of Miami - Miami
- Advent Health - Orlando
- Tampa General Hospital - Tampa
Illinois
- Northwestern University - Chicago
- University of Chicago Medicine - Chicago
- Loyola University Medical Center - Maywood
Arizona
- Mayo Clinic Arizona - Phoenix
Arkansas
- Baptist Health Arkansas - Little Rock
Connecticut
- Yale New Haven - New Haven
District of Columbia
- Medstar Washington Hospital Center - Washington D.C.
Georgia
- Piedmont Heart Institute - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,743 participants |
| Start Date | 2018-12-28 |
| Est. Completion | 2026-11 |
What the registry record for NCT03695601 still lists
NCT03695601 is an observational study that tracks outcomes without assigning an intervention. Its 2,743 participants enrollment target places it among the larger protocols in the corpus, above the 192-participant average among 5 other Heart Transplant Rejection trials with a reported enrollment target (1329% higher).
The record links to 1 condition, with Heart Transplant Rejection appearing as the primary indexed condition, and to 1 intervention - of which Standard of Care is the first listed.
NCT03695601 names 20 study sites across 8 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT03695601 about?
NCT03695601 is a clinical study titled "Surveillance HeartCare® Outcomes Registry". 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.
What is the current status of trial NCT03695601?
This trial is currently active not recruiting. The enrollment target is 2,743 participants. The study started on 2018-12-28. Estimated completion is 2026-11.
What conditions does trial NCT03695601 study?
This clinical trial studies the following conditions: Heart Transplant Rejection.
What interventions are being tested in trial NCT03695601?
The interventions under investigation include: Standard of Care (OTHER).
Who is sponsoring clinical trial NCT03695601?
This trial is sponsored by CareDx, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03695601 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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