Pericoronary Adipocyte Size Gradient (AdipoCor)

Institute for Clinical and Experimental Medicine

Status: Enrolling

Conditions: Heart Failure; Heart Transplantation

Treatments: Procedure: Heart transplantation for the final stage of heart failure

Study type: Observational

Funder types: Other

Identifiers

NCT07360925

AdipoCor2023

Details and patient eligibility

About

Evaluation of pericoronary adipocyte gradient (PCAT) in relationship with local atherosclerotic changes in a patient undergoing heart transplantation.

Full description

The project is designed to analyze the impact of inflammation spreading from pericoro-nary adipose tissue to the arterial wall or vice versa. Adipocyte size and immunometabolic parameters gradients established from independent analysis of samples closely adjacent to the coronary artery and those more distant from the arterial lumen will be used to establish the direction of inflammation propagation. The coronary arteries, along with adjacent pericoronary adipose tissue, from explanted hearts will be obtained during heart transplantation of patients with advanced atherosclerosis (ischemic heart disease) and with less advanced atherosclerotic disease (dilated cardiomyopathy).

Clinical data (including age, BMI, comorbidities, and concomitant medications) will be recorded. Specifically, previous left ventricular assist device (LVAD) implantation, used as a bridge-to-transplant approach, will be followed to establish the effect of artificial hemodynamic disturbance on coronary artery blood flow on study endpoints.

Enrollment: 60 estimated patients

Sex: All

Ages: 30 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 30-90 years
• Diagnosis of dilatational or ischemic cardiomyopathy
• Patients undergoing heart transplantation in IKEM

Exclusion criteria

• Known combined diagnosis of dilatational and ischemic cardiomyopathy
• Arrhythmogenic cardiomyopathy
• Congenital heart defects
• Non-eligibility due to the absence of informed consent

Trial design

60 participants in 1 patient group

patients with advanced heart failure

Description:

A group of patients with advanced heart failure were indicated for heart transplanta-tion for either ischemic or dilatational cardiomyopathy. The study group will also in-clude subjects with previously implanted LVAD as a bridge-to-transplant approach. Predictory-related subgroups will be evaluated separately.

Treatment:

Procedure: Heart transplantation for the final stage of heart failure