The Role of CD34 + Stem Cells and Biomarkers in the Development of CAV in HTX Patients

Completed

• Conditions: Heart Transplant Failure; Vasculopathy
• Interventions: Diagnostic Test: coronary CT angiography

• Registration Number: NCT05485467
• Lead Sponsor: University Medical Centre Ljubljana

Brief Summary

Coronary allograft vasculopathy represents one of the major limiting factors of long-term survival in heart transplant recipients. While extensively researched, the underlying mechanisms of coronary allograft vasculopathy (CAV) after heart transplantation remain incompletely understood. As CD34+ cells represent one of the key determinants of coronary vascular homeostasis we investigated the potential association between CAV and CD34+ cell count in heart transplant recipients.

Detailed Description

In a single-center prospective pilot cohort study, we aim to enroll 55 adult heart transplant recipients. All patients will undergo coronary CT angiography and the presence of CAV will be defined in accordance with the ISHLT criteria. At the time of CT angiography, patient will undergo detailed clinical evaluation, cardiac echo and we will also collect blood samples, perform extensive biochemical analysis and measure CD34+ cell count in peripheral venous blood using Beckman-Coulter Navios EX flow cytometry with standard antibodies according to ISAGE protocol. Biomarkers of angiogenesis will be evaluated using Luminex assay kit.

Study Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2022-06-23
• Study First Submitted QC: 2022-08-02
• Study First Posted: 2022-08-03
• Primary Completion: 2022-08-15
• Study Completion: 2022-08-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-05
• Last Update Posted: 2023-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• heart transplant recipient
• age > 18 years
• signed informed consent

Exclusion Criteria

• multiorgan transplantation
• eGFR < 30 ml/min
• known hypersensitivity to the contrast media
• history of any malignancy treated with radiation or chemotherapy
• therapy with mTOR inhibitors
• rejection > 1R within 90 days before enrollment
• G-CSF therapy within 30 days of enrollment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Heart transplant recipients	coronary CT angiography	All patients will undergo coronary CT angiography and the presence of CAV will be defined in accordance with the ISHLT criteria. At the time of CT angiography, the patient will undergo a detailed clinical evaluation, and cardiac echo and we will also collect blood samples, perform extensive biochemical analysis and measure CD34+ cell count in peripheral venous blood

Primary Outcome Measures

Name	Time	Method
CD34+ peripheral cell count in heart transplant recipients with and without coronary allograft vasculopathy	at the time of enrollment	CD34+ peripheral cell count in heart transplant recipients with and without coronary allograft vasculopathy

Secondary Outcome Measures

Name	Time	Method
The serum levels of biomarkers of angiogenesis in heart transplant recipients with and without coronary allograft vasculopathy	at the time of enrollment	The serum levels of biomarkers of angiogenesis (HIF 1a, SDF-1, IL-1, IL-6, TNFa, VEGF, FGF, EGF, Angiopoetin-2) in heart transplant recipients with and without coronary allograft vasculopathy

Trial Locations

Locations (1)

Advanced Heart Failure and Transplantation Center, University Medical Center Ljubljana; 🇸🇮 Ljubljana, Slovenia