Heart remodeling after endovascular aortic repair

Cardiac Remodelling Following Endovascular Repair of the Aorta

We will see if endovascular aortic repair changes heart size, shape, or function in adults treated for aortic aneurysms or related aortic problems.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa (Research network)
• Locations: 2 sites (Lisbon and 1 other locations)
• Trial ID: NCT07415447 on ClinicalTrials.gov

What this trial studies

This prospective observational cohort follows adults undergoing elective total endovascular aortic repair (EVAR) for degenerative thoracic or abdominal aneurysms, penetrating aortic ulcers, or intramural hematomas. Participants receive a baseline clinical exam, blood tests, CT, echocardiography, and cardiac magnetic resonance (CMR) before surgery, with the same imaging and testing repeated at 6 and 12 months after repair. The study measures changes in cardiac morphology and function over time using multimodality imaging and biomarkers. Patients with significant pre-existing cardiac disease, arrhythmias, severe valve disease, prior or expected cardiac/aortic surgery, advanced CKD, or contraindications to CMR are excluded.

Who should consider this trial

Good fit: Adults (≥18 years) scheduled for elective total EVAR for degenerative aortic aneurysm, penetrating aortic ulcer, or intramural hematoma who do not have major cardiac comorbidities are ideal candidates.

Not a fit: Patients with significant heart failure, arrhythmias (including atrial fibrillation), advanced valve disease, coronary disease, connective tissue disorders, severe pulmonary disease, or contraindications to CMR are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, results could clarify how EVAR affects the heart and help guide follow-up care to prevent or manage post-procedure cardiac problems.

How similar studies have performed: Previous observational work has reported cardiac changes after major aortic procedures, but detailed longitudinal CMR data specifically after EVAR are limited, making this approach partly novel.

Eligibility criteria

Inclusion Criteria:

\- Patients over 18-year-old, with degenerative arch, descending thoracic or abdominal aortic aneurysms, penetrating aortic ulcers or intramural hematomas managed with total EVAR in elective setting.

Exclusion Criteria:

* Heart failure with an ejection fraction \<35 vs 50% or New York Heart Association (NYHA) class III and IV.
* LV wall motion abnormality.
* Moderate to severe valve disease.
* History of (or expected within the study period) cardiac/aortic surgery.
* Coronary artery disease.
* Atrial fibrillation.
* Congenital heart disease.
* Connective tissue disorders.
* Chronic kidney disease (eGFR \<30 mL/min/173 m2).
* Moderate to severe pulmonary disease as indicate either by post bronchodilator FEV1 (%predicted) \<50% or Modified Medical Research Council Dyspnoea Scale (mMRC) 3-4.
* CMR contraindications (non-compatible pacemakers and metal implants, and claustrophobia).

Where this trial is running

Lisbon and 1 other locations

• Unidade Local de Saúde Santa Maria — Lisbon, Portugal (Recruiting)
• Unidade Local de Saúde de Santa Maria, E.P.E. — Lisbon, Portugal (Not_yet_recruiting)

Study contacts

• Study coordinator: Augusto Ministro Augusto Ministro

Conditions Cardiac Failure; Aortic Disease; cardiac; failure; aortic; disease