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Enrolling by Invitation

NCT Number: NCT07722793

EndoVascular Aneurysm Repair: Heart Remodeling and Aortic Stiffness Study

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.

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Key information

Conditions

Abdominal Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Arterial Stiffness Cardiovascular Diseases Left Ventricle Remodeling Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Diseases Ventricular Remodeling

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Vascular Surgery, University Hospital Center Osijek

Osijek, 31000, Croatia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Change in arterial stiffness after endovascular aneurysm repair (EVAR)

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

    Change in arterial stiffness after endovascular aneurysm repair (EVAR)

Secondary outcomes

  1. Early and long-term changes in arterial stiffness after EVAR

    Time frame: Baseline, 2 days, 6 months, 12 months

    Changes in PWV at 2 days, 6 months, and 12 months after EVAR compared with baseline.

  2. Changes in cardiac function after EVAR

    Time frame: Baseline, 2 days, 6 months, 12 months

    Changes in echocardiographic parameters of cardiac structure and function (LVEF, E/e', LA volume, LV volume, LA strain, LV strain etc.) following EVAR.

  3. Changes in circulating biomarkers after EVAR

    Time frame: Baseline, 2 days, 6 months, 12 months

    Changes in circulating biomarkers associated with vascular function, inflammation, and cardiovascular risk after EVAR.

Sponsors and collaborators

Lead sponsor

Josip Juraj Strossmayer University of Osijek

Other

Collaborators

  • University Hospital Center Osijek

Registry information

Official study title

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

Acronym: EVAR-HRAS

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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