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

NCT05485467 | Completed

• 1 other identifier: 02
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Vasculopathy; Heart Transplant Failure

Keywords

coronary allograft vasculopathy; CD34+ stem cells

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The serum levels of biomarkers of angiogenesis in heart transplant recipients with and without coronary allograft vasculopathy

  at the time of enrollment

Study Arms (1)

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, 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

Diagnostic Test: coronary CT angiography

Interventions

coronary CT angiography DIAGNOSTIC_TEST

Coronary CT angiography will be performed on multislice Siemens Somat Force CT scanner

Heart transplant recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients after heart transplantation, treated at Advanced Heart Failure and Transplantation Center, University Medical Center Ljubljana, Slovenia

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

Advanced Heart Failure and Transplantation Center, University Medical Center Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Gregor Poglajen, MD, PhD

  Advanced Heart Failure and Transplantation Center, Dept. of Cardiology, University Medical Center Ljubljana, Slovenia

  PRINCIPAL INVESTIGATOR

• Bojan Vrtovec, MD, PhD

  bojan.vrtovec@kclj.si

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: August 3, 2022
• Study Start: June 1, 2022
• Primary Completion: August 15, 2022
• Study Completion: August 31, 2022
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)