EndoVascular Aneurysm Repair: Heart Remodeling and Aortic Stiffness Study (EVAR-HRAS)

Impact of Endovascular Abdominal Aortic Aneurysm Repair on Aortic Stiffness and Left Ventricular Remodeling

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Abdominal Aortic Aneurysm; Arterial Stiffness; Left Ventricle Remodeling

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• Croatia
  • Osijek, Croatia, 31000
    • Department of Vascular Surgery, University Hospital Center Osijek

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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
• Severe hemodynamic instability or critical illness at the time of inclusion
• 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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early and long-term changes in arterial stiffness after EVAR	Changes in PWV at 2 days, 6 months, and 12 months after EVAR compared with baseline.	Baseline, 2 days, 6 months, 12 months
Changes in cardiac function after EVAR	Changes in echocardiographic parameters of cardiac structure and function (LVEF, E/e', LA volume, LV volume, LA strain, LV strain etc.) following EVAR.	Baseline, 2 days, 6 months, 12 months
Changes in circulating biomarkers after EVAR	Changes in circulating biomarkers associated with vascular function, inflammation, and cardiovascular risk after EVAR.	Baseline, 2 days, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Josip Juraj Strossmayer University of Osijek
• Collaborators: University Hospital Center Osijek
• Investigators: Study Chair: Ana Stupin, MD, PhD, Faculty of Medicine Osijek

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: July 20, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Pulse Wave Velocity; Echocardiography; Abdominal Aortic Aneurysm; Endovascular Aneurysm Repair; Left Ventricular Remodeling; Aortic Stiffness; Global Longitudinal Strain
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Diseases; Aneurysm; Aortic Aneurysm; Pathological Conditions, Signs and Symptoms; Aortic Aneurysm, Abdominal; Ventricular Remodeling
• Other Study ID Numbers: EVAR-HRAS Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No