Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID03102125

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

Led by Paul Kim · Updated on 2026-05-01

376

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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 heart's 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

Brief Title

Allograft Dysfunction in Heart Transplant

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than or equal to 18 years old.
  • At least three months status post heart transplantation.
Not Eligible

You will not qualify if you...

  • Biopsy proven acute rejection episode in the past 3 months.
  • 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.
  • 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.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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)

Long-term Monitoring

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

Trial Site Locations

Total: 1 location

1

UC San Diego

La Jolla, California, United States, 92037

Actively Recruiting

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Research Team

P

Paul Kim, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

4

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Published Research Related To This Trial

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

The ISHLT working formulation for pathologic diagnosis of antibody-mediated rejection in heart transplantation: evolution and current status (2005-2011).

Gerald J Berry, Annalisa Angelini, Margaret M Burke...

https://pubmed.ncbi.nlm.nih.gov/21555100

The International Society of Heart and Lung Transplantation Guidelines for the care of heart transplant recipients.

Maria Rosa Costanzo, Anne Dipchand, Randall Starling...

https://pubmed.ncbi.nlm.nih.gov/20643330

Development of coronary artery disease in cardiac transplant patients receiving immunosuppressive therapy with cyclosporine and prednisone.

B F Uretsky, S Murali, P S Reddy...

https://pubmed.ncbi.nlm.nih.gov/3308166

Detection and prediction of acute heart transplant rejection with the myocardial T2 determination provided by a black-blood magnetic resonance imaging sequence.

P Y Marie, M Angioï, J P Carteaux...

https://pubmed.ncbi.nlm.nih.gov/11693758