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EndoVascular Aneurysm Repair: Heart Remodeling and Aortic Stiffness Study

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07722793
Acronym
EVAR-HRAS
Enrollment
60
Registered
2026-07-23
Start date
2026-07-01
Completion date
2029-06-30
Last updated
2026-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

None listed

Sponsors

Josip Juraj Strossmayer University of Osijek
Lead SponsorOTHER
University Hospital Center Osijek
CollaboratorUNKNOWN

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in arterial stiffness after endovascular aneurysm repair (EVAR)Baseline (pre-EVAR) to 12 months after EVAR (2 days, 6 months, 12 months)Change in arterial stiffness after endovascular aneurysm repair (EVAR)

Secondary

MeasureTime frameDescription
Early and long-term changes in arterial stiffness after EVARBaseline, 2 days, 6 months, 12 monthsChanges in PWV at 2 days, 6 months, and 12 months after EVAR compared with baseline.
Change in left ventricular ejection fraction (LVEF)Baseline, 2 days, 6 months, 12 monthsChanges in left ventricular ejection fraction following endovascular aneurysm repair (EVAR), assessed by transthoracic echocardiography.
Changes in circulating biomarkers after EVARBaseline, 2 days, 6 months, 12 monthsChanges in circulating biomarkers associated with vascular function, inflammation, and cardiovascular risk after EVAR.
Change in left ventricular filling pressure (E/e')Baseline, 2 days, 6 months, 12 monthsChanges in the E/e' ratio, an echocardiographic marker of left ventricular filling pressure and diastolic function, following EVAR.
Change in left atrial volume index (LAVI)Baseline, 2 days, 6 months, 12 monthsChanges in left atrial volume index following EVAR, assessed by transthoracic echocardiography.
Change in left ventricular end-diastolic volume (LVEDV)Baseline, 2 days, 6 months, 12 monthsChanges in left ventricular end-diastolic volume following EVAR, assessed by transthoracic echocardiography.
Change in left ventricular global longitudinal strain (LV GLS)Baseline, 2 days, 6 months, 12 monthsChanges in left ventricular global longitudinal strain, a sensitive marker of left ventricular systolic function, following EVAR.
Change in left atrial reservoir strain (LA reservoir strain)Baseline, 2 days, 6 months, 12 monthsChanges in left atrial reservoir strain following EVAR, assessed using speckle-tracking echocardiography.

Countries

Croatia

Contacts

STUDY_CHAIRAna Stupin, MD, PhD

Faculty of Medicine Osijek

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 6, 2026