The Registry of the International Society for Heart and Lung Transplantation: Twenty-eighth Adult Heart Transplant Report--2011.
Josef Stehlik, Leah B Edwards, Anna Y Kucheryavaya...
https://pubmed.ncbi.nlm.nih.gov/21962016/Actively Recruiting
Led by Paul Kim · Updated on 2026-05-01
376
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are studying adult heart transplant patients to find early signs of heart transplant problems using cardiac MRI and single cell RNA sequencing. This study focuses on understanding the molecular and larger-scale causes of allograft dysfunction, which can affect the transplanted hearts performance. The study excludes patients with severe kidney problems or those who cannot safely undergo MRI or receive certain contrast agents. Participants will undergo stress cardiac MRI with a drug called regadenoson, along with special imaging sequences before and after gadolinium contrast. This includes capturing cine images, T1 and T2 mapping, and late gadolinium enhancement. Blood samples and heart tissue biopsies will be collected as part of routine care and for detailed molecular analysis. The study groups include patients with different types of heart transplant function, all receiving similar imaging and testing procedures. Participants will be followed for at least one year after enrollment to monitor heart function and major adverse cardiac events. The study will measure heart blood flow reserve, heart function, tissue characteristics, and heart muscle strain over five years. Imaging results will be reviewed by independent readers, and clinical data will be collected regularly to assess heart transplant health and longevity.
CONDITIONS
Allograft Dysfunction in Heart Transplant
P
Paul Kim, MD
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Paul Kim
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Regadenoson-Stress Cardiac MRI (Investigational) | Current-Care: Endomyocardial Biopsy & Standard Surveillance |
|---|---|---|
| What is it? | A noninvasive diagnostic method using Regadenoson as a vasodilator during stress cardiac magnetic resonance imaging (MRI) to assess myocardial perfusion and tissue characteristics in adults after heart transplantation. | Current standard-care surveillance for cardiac transplant patients involves routine endomyocardial biopsy (EMB) and adjunct guideline-directed modalities to detect allograft dysfunction and rejection. |
| Role in the study | Every participant undergoes Regadenoson stress MRI for assessment, covering different clinical categories post-transplant. | Serves as the principal established diagnostic and surveillance pathway outside of investigational trial protocols. |
| Primary use or clinical role | Designed to noninvasively diagnose or characterize cardiac allograft dysfunction, including vasculopathy and rejection, after heart transplantation. | Routine monitoring, early detection, and confirmation of allograft dysfunction and rejection by tissue pathology and/or established surveillance tools. |
| How it is performed | Participants receive an intravenous infusion of Regadenoson followed by cardiac MRI to assess stress-induced changes in perfusion and myocardial tissue, without requiring tissue sampling. | Typically involves fluoroscopy-guided endomyocardial biopsy via venous access to obtain heart tissue samples, often performed on a scheduled basis or as clinically indicated. |
| Evidence status | Evidence for Regadenoson stress MRI in heart transplant patients is growing, with pilot studies and ongoing trials examining its diagnostic accuracy, but large-scale validation is not yet established. | Substantial published evidence and long-term multicenter experience support endomyocardial biopsy as the reference method for transplant surveillance and rejection diagnosis. |
| Important limitations | May not detect all forms of immune or microvascular rejection; cannot be used in patients with contraindications to MRI or Regadenoson; insufficient data for definitive replacement of biopsy in all patients at this time. | Endomyocardial biopsy is invasive, carries procedural risks, and may be subject to sampling error and interobserver variability in pathological diagnosis. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single assessment at enrollment
Participants undergo stress cardiac MRI with regadenoson, late gadolinium enhancement imaging, and T1 and T2 mapping sequences to assess heart function. Peripheral blood and endomyocardial biopsies are collected according to usual clinical care and for-cause for advanced analyses.
1 visit (in-person)
Duration - At least 1 year
Participants are followed for at least 1 year after enrollment to monitor major adverse cardiac events and assess heart transplant graft function over time.
Follow-up visits as per clinical care
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
4
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https://pubmed.ncbi.nlm.nih.gov/3308166/Paul Kim
Lead Sponsor