Abdominal Aortic AneurysmEVAR-HRASNCT07722793
EndoVascular Aneurysm Repair: Heart Remodeling and Aortic Stiffness Study
An observational study of Abdominal Aortic Aneurysm and Arterial Stiffness, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm, Arterial Stiffness, Left Ventricle Remodeling
- How many people
- 60 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Jul 2026to 30 Jun 2029
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site
Department of Vascular Surgery, University Hospital Center Osijek
Osijek, 31000
About this study
Official title: 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.
- Keywords
- Abdominal Aortic Aneurysm, Endovascular Aneurysm Repair, Aortic Stiffness, Pulse Wave Velocity, Left Ventricular Remodeling, Global Longitudinal Strain, Echocardiography
- Medical subject headings
- Aortic Aneurysm, Abdominal, Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in arterial stiffness after endovascular aneurysm repair (EVAR)
Change in arterial stiffness after endovascular aneurysm repair (EVAR)
Measured: Baseline (pre-EVAR) to 12 months after EVAR (2 days, 6 months, 12 months)
Secondary outcomes (8)
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.
Measured: Baseline, 2 days, 6 months, 12 months
Change in left ventricular ejection fraction (LVEF)
Changes in left ventricular ejection fraction following endovascular aneurysm repair (EVAR), assessed by transthoracic echocardiography.
Measured: 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.
Measured: Baseline, 2 days, 6 months, 12 months
Change in left ventricular filling pressure (E/e')
Changes in the E/e' ratio, an echocardiographic marker of left ventricular filling pressure and diastolic function, following EVAR.
Measured: Baseline, 2 days, 6 months, 12 months
Change in left atrial volume index (LAVI)
Changes in left atrial volume index following EVAR, assessed by transthoracic echocardiography.
Measured: Baseline, 2 days, 6 months, 12 months
Change in left ventricular end-diastolic volume (LVEDV)
Changes in left ventricular end-diastolic volume following EVAR, assessed by transthoracic echocardiography.
Measured: Baseline, 2 days, 6 months, 12 months
Change in left ventricular global longitudinal strain (LV GLS)
Changes in left ventricular global longitudinal strain, a sensitive marker of left ventricular systolic function, following EVAR.
Measured: Baseline, 2 days, 6 months, 12 months
Change in left atrial reservoir strain (LA reservoir strain)
Changes in left atrial reservoir strain following EVAR, assessed using speckle-tracking echocardiography.
Measured: Baseline, 2 days, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Jul 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Josip Juraj Strossmayer University of Osijek
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Center Osijek
- Responsible party
- Principal investigator, Ines Drenjancevic, Josip Juraj Strossmayer University of Osijek
- Investigators
- Ana Stupin, MD, PhD, Study chair, Faculty of Medicine Osijek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722793
- Sponsor's protocol ID
- EVAR-HRAS Study
- Acronym
- EVAR-HRAS
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Endovascular Abdominal Aortic Aneurysm Repair on Aortic Stiffness and Left Ventricular Remodeling
- ClinicalTrials.gov ID
- NCT07722793
- Acronym / sponsor ID
- EVAR-HRAS / EVAR-HRAS Study
- Keywords
- Abdominal Aortic Aneurysm, Endovascular Aneurysm Repair, Aortic Stiffness, Pulse Wave Velocity, Left Ventricular Remodeling, Global Longitudinal Strain, Echocardiography
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Josip Juraj Strossmayer University of OsijekUniversity, hospital or other
- Collaborators
- University Hospital Center Osijek
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ana Stupin, MD, PhD study chair
Faculty of Medicine Osijek
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm and Arterial Stiffness, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.