EndoVascular Aneurysm Repair: Heart Remodeling and Aortic Stiffness Study

NCT07722793 | Enrolling By Invitation

• 1 other identifier: EVAR-HRAS Study
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Abdominal aortic aneurysm (AAA) is associated with a high burden of cardiovascular morbidity and mortality. Although endovascular aneurysm repair (EVAR) has become the preferred treatment for many patients with infrarenal AAA because of its lower perioperative risk, its impact on arterial stiffness and cardiac function remains insufficiently understood. Experimental and clinical evidence suggests that endograft implantation may increase aortic stiffness by reducing aortic compliance, potentially altering ventricular-arterial coupling and contributing to left ventricular remodeling and dysfunction. This prospective observational study aims to evaluate the effects of elective EVAR on aortic stiffness, left ventricular structure and function, and circulating biomarkers of myocardial stress and extracellular matrix remodeling. Patients with infrarenal AAA scheduled for elective EVAR will be assessed before the procedure and at 48 hours, 6 months, and 12 months after intervention. Aortic stiffness will be assessed using estimated carotid-femoral pulse wave velocity (cfPWV), while left ventricular function and remodeling will be evaluated by transthoracic echocardiography, including global longitudinal strain (GLS). Circulating NT-proBNP and MMP-3 concentrations will also be measured. The study will provide insight into the cardiovascular effects of EVAR and may improve understanding of procedure-related changes in arterial stiffness and cardiac remodeling, thereby supporting better long-term cardiovascular risk assessment and postoperative management in patients undergoing EVAR.

Conditions

Abdominal Aortic Aneurysm; Arterial Stiffness; Left Ventricle Remodeling

Keywords

Abdominal Aortic Aneurysm; Endovascular Aneurysm Repair; Aortic Stiffness; Pulse Wave Velocity; Left Ventricular Remodeling; Global Longitudinal Strain; Echocardiography

Outcome Measures

Primary Outcomes (1)

• Change in arterial stiffness after endovascular aneurysm repair (EVAR)

  Change in arterial stiffness after endovascular aneurysm repair (EVAR)

  Baseline (pre-EVAR) to 12 months after EVAR (2 days, 6 months, 12 months)

Secondary Outcomes (3)

• Early and long-term changes in arterial stiffness after EVAR

  Baseline, 2 days, 6 months, 12 months

• Changes in cardiac function after EVAR

  Baseline, 2 days, 6 months, 12 months

• Changes in circulating biomarkers after EVAR

  Baseline, 2 days, 6 months, 12 months

Study Arms (1)

EVAR patients

Patients undergoing endovascular aneurysm repair (EVAR) with assessment of arterial stiffness and cardiac function before the procedure and during follow-up (2 days, 6 months, and 12 months after EVAR).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with abdominal aortic aneurysm (AAA) scheduled for elective endovascular aneurysm repair (EVAR) will be prospectively enrolled. The study population will include patients undergoing standard-of-care EVAR, who will be followed longitudinally to assess changes in arterial stiffness, cardiac function, and circulating biomarkers before and after the procedure.

You may qualify if:

• Adult patients (≥18 years of age) with diagnosed abdominal aortic aneurysm (AAA) who are scheduled for elective endovascular aneurysm repair (EVAR)
• Patients eligible for EVAR according to current clinical guidelines and anatomical criteria
• Signed informed consent for participation in the study
• Ability to undergo scheduled follow-up examinations (baseline, early post-procedural assessment, and follow-up visits)

You may not qualify if:

• Emergency EVAR for ruptured or symptomatic abdominal aortic aneurysm
• Previous aortic repair or previous endovascular intervention involving the abdominal aorta
• Concomitant major cardiovascular surgery or intervention during the study period
• Active infection or acute inflammatory disease that may influence vascular or inflammatory biomarkers
• Malignancy with active treatment or life expectancy limiting follow-up
• Inability to provide informed consent
• Inability to complete planned follow-up assessments
• Known severe valvular heart disease or advanced heart failure
• Conditions affecting arterial stiffness measurements (e.g. atrial fibrillation, severe arrhythmias, inability to obtain reliable PWV measurements)

Sponsors & Collaborators

• Josip Juraj Strossmayer University of Osijek: lead
• University Hospital Center Osijek: collaborator

Study Sites (1)

Department of Vascular Surgery, University Hospital Center Osijek

Osijek, 31000, Croatia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral venous blood samples will be collected before EVAR and during follow-up visits for analysis of circulating biomarkers related to vascular function, inflammation, and cardiovascular risk. Samples will be stored for the purposes of the present study.

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Ventricular Remodeling

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ana Stupin, MD, PhD

  Faculty of Medicine Osijek

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ana Stupin, Vice-Dean for Science Faculty of Medicine Osijek

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 23, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)