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

Heart Transplant Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05485467
• Other study ID #: 02
• Status: Completed
• Start date: June 1, 2022
• Est. completion date: August 31, 2022

Study information

• Verified date: November 2023
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: August 31, 2022
• Est. primary completion date: August 15, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Transplant Failure
• Vascular Diseases
• Vasculopathy

Intervention

Diagnostic Test:
• coronary CT angiography
Coronary CT angiography will be performed on multislice Siemens Somat Force CT scanner

Locations

Country	Name	City	State
Slovenia	Advanced Heart Failure and Transplantation Center, University Medical Center Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CD34+ peripheral cell count in heart transplant recipients with and without coronary allograft vasculopathy	CD34+ peripheral cell count in heart transplant recipients with and without coronary allograft vasculopathy	at the time of enrollment
Secondary	The serum levels of biomarkers of angiogenesis in heart transplant recipients with and without coronary allograft vasculopathy	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	at the time of enrollment