Health TrialsbyHealthPanel

Allograft Dysfunction in Heart Transplant

ConditionHeart Transplant Failure and Rejection
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorPaul Kim

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age greater than or equal to 18 years old.

At least three months status post heart transplantation.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Regadenoson

    Drug

    For use in stress myocardial perfusion imaging.

Treatment groups

376 Participants
are divided into 4 treatment groups
Group A: Nonspecific allograft dysfunctionExperimental treatment 1 intervention
Group B: Normal graft functionExperimental treatment 1 intervention
Group C: Cardiac allograft vasculopathyExperimental treatment 1 intervention
Group D: ACR/AMRExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

1

Major adverse cardiovascular events

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

Time frame
60 months
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

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.

Time frame
60 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Paul Kim

Lead sponsor

University of California, San Diego

Sponsor institution

Source ClinicalTrials.gov
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