Evaluating heart transplant dysfunction using MRI and sequencing
Defining Mechanisms for Cardiac Allograft Dysfunction to Improve Allograft Longevity and Survival in Heart-Transplant Patients
This study is testing if heart scans and genetic analysis can help find early signs of problems in heart transplant patients to improve their care.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 376 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT03102125 on ClinicalTrials.gov |
What this trial studies
This study aims to assess early signs of cardiac allograft dysfunction in heart transplant patients through cardiac MRI and single cell sequencing. Adult participants, who are at least three months post-heart transplantation and meet specific eligibility criteria, will undergo various imaging techniques and biopsies to identify molecular and macroscopic causes of dysfunction. The study will take place over 60 months at UC San Diego, with follow-up for major adverse cardiac events for at least one year after enrollment.
Who should consider this trial
Good fit: Ideal candidates are adult heart transplant recipients who are at least three months post-transplant and do not have contraindications to MRI or specific medical conditions.
Not a fit: Patients with recent acute rejection episodes, significant renal dysfunction, or contraindications to MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved detection and management of heart transplant dysfunction, potentially enhancing patient outcomes.
How similar studies have performed: Other studies utilizing cardiac MRI for transplant assessment have shown promise, indicating that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
La Jolla, California
- UC San Diego — La Jolla, California, United States (Recruiting)
Study contacts
- Principal investigator: Paul Kim, MD — UC San Diego
- Study coordinator: Paul Kim, MD
- Email: pjk017@ucsd.edu
- Phone: 8582460638
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.