Clinical trial NCT05485467: The Role of CD34 + Stem Cells and Biomarkers in the Development of CAV in HTX Patients
Official title: The Role of CD34 + Stem Cells and Biological Markers of Angiogenesis in the Development of Coronary Allograft Vasculopathy in Patients After Heart Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vasculopathy
Heart Transplant Failure
Keywords: coronary allograft vasculopathy
CD34+ stem cells
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2022-08-03
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after heart transplantation, treated at Advanced Heart Failure and Transplantation Center, University Medical Center Ljubljana, Slovenia

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.

Eligibility criteria: 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

Primary outcomes:
measure: CD34+ peripheral cell count in heart transplant recipients with and without coronary allograft vasculopathy
timeFrame: at the time of enrollment
Secondary outcomes:
measure: The serum levels of biomarkers of angiogenesis in heart transplant recipients with and without coronary allograft vasculopathy
timeFrame: at the time of enrollment
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Advanced Heart Failure and Transplantation Center, University Medical Center Ljubljana
Study officials:
affiliation: Advanced Heart Failure and Transplantation Center, Dept. of Cardiology, University Medical Center Ljubljana, Slovenia
name: Gregor Poglajen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: bojan.vrtovec@kclj.si
name: Bojan Vrtovec, MD, PhD
role: STUDY_CHAIR
References: