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NCT Number: NCT03102125

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UC San Diego

La Jolla, California, 92037, United States

Location status: Recruiting

Location contact

Paul Kim, MD

CONTACT

[email protected]

8582460638

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Regadenoson

Drug

For use in stress myocardial perfusion imaging.

Other names: Lexiscan

Primary outcomes

  1. Myocardial Perfusion Reserve

    Time frame: 60 months

Secondary outcomes

  1. Rest and stress myocardial blood flow

    Time frame: 60 months

  2. LGE %

    Time frame: 60 months

  3. LVEF

    Time frame: 60 months

  4. LV end-diastolic volume index

    Time frame: 60 months

  5. LV mass index

    Time frame: 60 months

  6. native T1 and T2 myocardial values

    Time frame: 60 months

  7. extracellular volumes

    Time frame: 60 months

  8. myocardial strain rate

    Time frame: 60 months

Other outcomes

  1. Major adverse cardiovascular events

    Time frame: 60 months

    death, re-transplantation, percutaneous coronary intervention and HF hospitalization

  2. Percentage of different T-cell subsets by single cell RNAseq

    Time frame: 60 months

  3. Number of stenotic microvasculopathy by histopathologic review of endomyocardial biopsy samples

    Time frame: 60 months

    Each endomyocardial biopsy slide will be reviewed for stenotic microvasculopathy as per Hiemann et al 2007, Circulation. 1 stenotic blood vessel per view on X200 zoom is diagnostic of stenotic microvasculopathy.

Study contacts

Contact information is provided by the study sponsor or research team.

Paul Kim, MD

CONTACT

[email protected]

8582460638

Sponsors and collaborators

Lead sponsor

Paul Kim

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Apr 5, 2017
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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