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Recruiting INTERVENTIONAL NCT03102125

Allograft Dysfunction in Heart Transplant

Defining Mechanisms for Cardiac Allograft Dysfunction to Improve Allograft Longevity and Survival in Heart-Transplant Patients

Sponsor: Paul Kim

Interventions Regadenoson
Updated 15 times since 2017 Last updated: Apr 27, 2026 Started: Oct 1, 2019 Primary completion: Jan 1, 2027 Completion: Jan 2, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~May 2017 – ~Nov 2017 · 6 months · monthly snapshot~Nov 2017 – ~Jun 2018 · 7 months · monthly snapshot~Jun 2018 – ~May 2019 · 11 months · monthly snapshot~May 2019 – ~Aug 2019 · 3 months · monthly snapshot~Aug 2019 – ~Sep 2020 · 13 months · monthly snapshot~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshot~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshot~Dec 2021 – ~Feb 2023 · 14 months · monthly snapshot~Feb 2023 – ~Feb 2024 · 12 months · monthly snapshot~Feb 2024 – ~Jun 2024 · 4 months · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Mar 2025 · 6 months · monthly snapshot~Mar 2025 – ~May 2026 · 14 months · monthly snapshotMay 4, 2026 – present · 2 months · daily API

Change History

15 versions recorded
  1. May 4, 2026 — Present [daily]

    Recruiting

    Phase: PHASE4None

  2. Mar 2025 — May 2026 [monthly]

    Recruiting PHASE4

  3. Sep 2024 — Mar 2025 [monthly]

    Recruiting PHASE4

  4. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE4

  5. Jun 2024 — Jul 2024 [monthly]

    Recruiting PHASE4

Show 10 earlier versions
  1. Feb 2024 — Jun 2024 [monthly]

    Recruiting PHASE4

  2. Feb 2023 — Feb 2024 [monthly]

    Recruiting PHASE4

  3. Dec 2021 — Feb 2023 [monthly]

    Recruiting PHASE4

  4. Jan 2021 — Dec 2021 [monthly]

    Recruiting PHASE4

  5. Sep 2020 — Jan 2021 [monthly]

    Recruiting PHASE4

  6. Aug 2019 — Sep 2020 [monthly]

    Recruiting PHASE4

  7. May 2019 — Aug 2019 [monthly]

    Recruiting PHASE4

    Status: Not Yet RecruitingRecruiting

  8. Jun 2018 — May 2019 [monthly]

    Not Yet Recruiting PHASE4

  9. Nov 2017 — Jun 2018 [monthly]

    Not Yet Recruiting PHASE4

  10. 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

Sponsor contact:
  • Paul Kim
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations