Allograft Dysfunction in Heart Transplant
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.
Conditions:
🦠 Heart Transplant Failure and Rejection
🗓️ Study Start (Actual) 1 October 2019
🗓️ Primary Completion (Estimated) 1 December 2024
✅ Study Completion (Estimated) 2 December 2024
👥 Enrollment (Estimated) 376
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 La Jolla, California, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Age greater than or equal to 18 years old.
    • * At least three months status post heart transplantation.

    Exclusion Criteria:

    • * Biopsy proven acute rejection episode in the past 3 months.
    • * Patients with symptoms or signs of acute myocardial ischemia or recent acute coronary syndrome in the past 3 months.
    • * Uncontrolled obstructive ventilatory disease including asthma and COPD.
    • * History of generalized tonic-clonic seizures.
    • * Second or third degree AV nodal block.
    • * Sinus node dysfunction.
    • * Contraindications to MRI including cardiovascular implantable electronic devices.
    • * Renal dysfunction with an estimated GFR less than 30 mL/min/1.73m2.
    • * Prior adverse reaction to either regadenoson or gadolinium contrast. Prior adverse reaction to adenosine or dipyridamole will be assessed on a case-by-case basis.
    • * Systolic blood pressure greater than 180 or less than 85 mmHg.
    • * Diastolic blood pressure greater than 120 or less than 40 mmHg.
    • * Resting heart rate greater than 120 or less than 45 beats per minute. - Severe claustrophobia.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 29 March 2017
  • First Submitted that Met QC Criteria 29 March 2017
  • First Posted 5 April 2017

Study Record Updates

  • Last Update Submitted that Met QC Criteria 6 May 2024
  • Last Update Posted 8 May 2024
  • Last Verified January 2024