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Severe CAV MRI in Heart Transplant Recipient

Evaluation of Genomic, Structural and Molecular Changes Associated With Severe Cardiac Allograft Vasculopathy in Heart Transplant Recipients

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02777255
Enrollment
0
Registered
2016-05-19
Start date
2012-05-31
Completion date
2014-12-31
Last updated
2016-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Allograft Vasculopathy

Brief summary

Hypothesis: CAV is associated with fibrotic changes on cardiac MRI, altered levels of pathogenetically-related biomarkers, and specific RNA expression changes in the blood

Detailed description

Cardiac allograft vasculopathy (CAV) is a major limitation to longevity after heart transplantation (HT), accounting for almost 30% of deaths after year 5. The only cure is re-transplant which is associated with a 30-day mortality of 30%, and raises ethical issues due to limited resources. Standard preventive measures, such as statin therapy, have limited success due to the multi-factorial nature of the process and influence of transplant-specific risk factors. Consensus regarding the management of CAV is lacking due to the absence of prospective studies evaluating timing of initiation of therapy, effect of therapies on long-term outcomes, and effective diagnostic strategies. Primary prevention of CAV, which will be evaluated in the proposed study, could improve longevity of heart transplant recipients and optimize use of a limited resource. The current gold standard for evaluation of CAV is surveillance coronary angiogram, which is highly insensitive, particularly in early disease. Intravascular ultrasound (IVUS) is the most sensitive tool for the diagnosis of CAV, providing specific information such as the appearance and thickness of the intima and media, however it is not widely used in the clinical setting. Physiologic studies of the coronary arteries are also useful in assessing risk, but are not practical in a clinical setting. These invasive studies expose the heart transplant recipient to radiation, nephrotoxic contrast, and potential vascular complications. During the evolution of CAV, there are important structural, functional, and genomic changes that occur in parallel and possibly before. Study Objectives 1. Determine the structural, functional and genomic changes associated with severe CAV 2. Identify novel and noninvasive markers of CAV Study Design This is a cross-sectional study which will evaluate structural, functional and genomic changes associated with severe CAV in heart transplant recipients within 15 years of transplant. 30 heart transplant recipients identified via our study database and the transplant clinic will be enrolled into the study. We will enroll 15 heart transplant patients with severe CAV and 15 without CAV. Subjects will undergo a one-time assessment of radial artery elasticity, blood draw for gene expression profiles, and cardiac MRI.

Interventions

None listed

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥ 18 years * Provide informed consent * Successful orthotopic heart transplant within 15 years of enrollment

Exclusion criteria

* Chronic kidney disease with creatinine \>2.5 mg/dl * Ejection fraction \<45% if CAV or \<50% if no CAV * IV contrast allergy or reaction (gadolinium) * Active infection (febrile illness, cytomegalovirus or other significant infection) * Treated humoral rejection or cellular rejection grade 3A/2R or greater within 3 months * Contraindication to MRI

Design outcomes

Primary

MeasureTime frameDescription
Changes from baseline associated with severe CAV1 yearDetermine the structural (degree of fibrosis), functional and genomic changes associated with severe CAV

Secondary

MeasureTime frameDescription
Novel noninvasive markers of CAV from baseline1 yearIdentify novel and noninvasive markers of CAV

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026