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Enrolling by invitation NCT07722793

EndoVascular Aneurysm Repair: Heart Remodeling and Aortic Stiffness Study

— Observational Abdominal Aortic Aneurysm Arterial Stiffness Left Ventricle Remodeling

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Abdominal Aortic Aneurysm, Arterial Stiffness, Left Ventricle Remodeling. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Croatia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Primary outcome measures

  • 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)]
Secondary outcome measures (8)
  • Early and long-term changes in arterial stiffness after EVAR [Time frame: Baseline, 2 days, 6 months, 12 months]
  • Change in left ventricular ejection fraction (LVEF) [Time frame: Baseline, 2 days, 6 months, 12 months]
  • Changes in circulating biomarkers after EVAR [Time frame: Baseline, 2 days, 6 months, 12 months]
  • Change in left ventricular filling pressure (E/e') [Time frame: Baseline, 2 days, 6 months, 12 months]
  • Change in left atrial volume index (LAVI) [Time frame: Baseline, 2 days, 6 months, 12 months]
  • Change in left ventricular end-diastolic volume (LVEDV) [Time frame: Baseline, 2 days, 6 months, 12 months]
  • Change in left ventricular global longitudinal strain (LV GLS) [Time frame: Baseline, 2 days, 6 months, 12 months]
  • Change in left atrial reservoir strain (LA reservoir strain) [Time frame: Baseline, 2 days, 6 months, 12 months]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Croatia · 1 center
  • Department of Vascular Surgery, University Hospital Center Osijek — Osijek

Identifiers

NCT: NCT07722793 · EVAR-HRAS Study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗