Cardiac Remodelling Following Endovascular Repair of the Aorta

NCT07415447 | Recruiting

• 1 other identifier: 2023.15211.PEX
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

To assess the effects of endovascular aortic repair on cardiac morphology and function

Conditions

Cardiac Failure; Aortic Disease

Keywords

cardiac; failure; aortic; disease

Outcome Measures

Primary Outcomes (1)

• To estimate cardiac remodelling in patients who have undergone EVAR by comparing baseline left ventricular mass with those obtained after a 12-month period.

  The cardiac remodelling will be estimated through the variables of left ventricular mass at baseline and 12 months, measured in grams through CMR.

  12-month period

Secondary Outcomes (7)

• To estimate the cardiac remodelling in patients who have undergone EVAR by comparing baseline left ventricular mass/volume/strain measurements with those obtained after a 6-month period.

  6-month period

• To estimate cardiac remodelling in patients who have undergone EVAR by comparing baseline left ventricular volume and strain measurements with those obtained after a 12-month period.

  12-months period

• To estimate the cardiac remodelling in patients who have undergone EVAR by comparing baseline ECHO and CMR cardiac measurements with those obtained after 6- and 12-months periods.

  6- and 12-months periods

• To correlate heart proximity and endograft extension with cardiac remodelling variables.

  12-month period

• To create a composite variable using cardiac biomarkers that correlate with cardiac remodelling variables at 6-months and 12-months

  6-month and 12-month periods

Study Arms (1)

Participants submitted to aortic repair

Participants submitted endovascular repair of the aorta

Diagnostic Test: cardiac magnetic ressonance

Interventions

cardiac magnetic ressonance DIAGNOSTIC_TEST

In patients with aortic disease submitted to endovascular repair, will be studied through cardiac magnetic ressonance to evaluate cardiac function

Participants submitted to aortic repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We will include consecutive patients, \>18 year-old, with degenerative arch, descending thoracic or abdominal aortic aneurysms (TAA), penetrating aortic ulcers (PAU) or intramural hematomas (IMH) managed with total endovascular aortic repair in elective setting. We will exclude patients with 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 or congenital heart disease. Additionally, we will dismiss patients with 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 Dyspnea Scale (mMRC) 3-4, and standard CMR contraindications (non-compatible pacemakers and metal implants, and claustrophobia).

You may qualify if:

• \- 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa: lead

Study Sites (2)

Unidade Local de Saúde Santa Maria

Lisbon, 1649-028, Portugal

RECRUITING

Unidade Local de Saúde de Santa Maria, E.P.E.

Lisbon, Portugal

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

Heart Failure; Aortic Diseases; Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Augusto Ministro Augusto Ministro

CONTACT

00531 210405814; cic@ulssm.min-saude.pt

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Academic and Clinical Professor

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: February 17, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

PT (2)