Allograft Dysfunction in Heart Transplant
Defining Mechanisms for Cardiac Allograft Dysfunction to Improve Allograft Longevity and Survival in Heart-Transplant Patients
Sponsor: Paul Kim
Listed as NCT03102125, this observational or N/A phase trial focuses on Heart Transplant Failure and Rejection and remains actively recruiting participants. Sponsored by Paul Kim, it has been updated 15 times since 2019, reflecting substantial change activity. This study contributes longitudinal data to the cardiovascular research landscape.
Study Description(click to expand)Adult heart-transplant patients, excluding those with a GFR less than 30 mL/min/1.73m2, contraindications to MRI and allergies to either regadenoson or gadolinium contrast, will be enrolled over 60 months. Patients will be recruited from UCSD. The investigators will specifically enroll all eligible heart-transplant patients.
Brief protocol:
Cardiac MRI is performed. Cine images in standard views are obtained. T1 and T2 mapping sequences are performed on short axis images pre- and post-gadolinium contrast. For stress imaging, intravenous regadenoson is given as a 0.4 mg bolus followed by a 5 mL saline flush. After 30 seconds, short-axis images are acquired for 30 consecutive heartbeats with administration of gadolinium. Rest imaging is performed 30 minutes after stress imaging. Lastly, late gadolinium enhancement images are obtained in standard views. Images are analyzed offline by a blinded independent reader. Patients will be followed for at least 1 year after enrollment for MACE.
Peripheral blood and endomyocardial biopsies will also be collected, timing as per usual clinical care as well as for-cause, for single cell RNAseq analyses.
Adult heart-transplant patients, excluding those with a GFR less than 30 mL/min/1.73m2, contraindications to MRI and allergies to either regadenoson or gadolinium contrast, will be enrolled over 60 months. Patients will be recruited from UCSD. The investigators will specifically enroll all eligible heart-transplant patients.
Brief protocol:
Cardiac MRI is performed. Cine images in standard views are obtained. T1 and T2 mapping sequences are performed on short axis images pre- and post-gadolinium contrast. For stress imaging, intravenous regadenoson is given as a 0.4 mg bolus followed by a 5 mL saline flush. After 30 seconds, short-axis images are acquired for 30 consecutive heartbeats with administration of gadolinium. Rest imaging is performed 30 minutes after stress imaging. Lastly, late gadolinium enhancement images are obtained in standard views. Images are analyzed offline by a blinded independent reader. Patients will be followed for at least 1 year after enrollment for MACE.
Peripheral blood and endomyocardial biopsies will also be collected, timing as per usual clinical care as well as for-cause, for single cell RNAseq analyses.
Status Flow
Change History
15 versions recorded-
May 4, 2026 — Present [daily]
Recruiting
Phase: PHASE4 → None
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Mar 2025 — May 2026 [monthly]
Recruiting PHASE4
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Sep 2024 — Mar 2025 [monthly]
Recruiting PHASE4
-
Jul 2024 — Sep 2024 [monthly]
Recruiting PHASE4
-
Jun 2024 — Jul 2024 [monthly]
Recruiting PHASE4
▶ Show 10 earlier versions
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Feb 2024 — Jun 2024 [monthly]
Recruiting PHASE4
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Feb 2023 — Feb 2024 [monthly]
Recruiting PHASE4
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Dec 2021 — Feb 2023 [monthly]
Recruiting PHASE4
-
Jan 2021 — Dec 2021 [monthly]
Recruiting PHASE4
-
Sep 2020 — Jan 2021 [monthly]
Recruiting PHASE4
-
Aug 2019 — Sep 2020 [monthly]
Recruiting PHASE4
-
May 2019 — Aug 2019 [monthly]
Recruiting PHASE4
Status: Not Yet Recruiting → Recruiting
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Jun 2018 — May 2019 [monthly]
Not Yet Recruiting PHASE4
-
Nov 2017 — Jun 2018 [monthly]
Not Yet Recruiting PHASE4
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May 2017 — Nov 2017 [monthly]
Not Yet Recruiting PHASE4
First recorded
Eligibility Summary
The investigators will evaluate for early evidence of cardiac allograft dysfunction by cardiac MRI and single cell sequencing to determine underlying molecular and macroscopic causes.
Contact Information
- Paul Kim
For direct contact, visit the study record on ClinicalTrials.gov .