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NCT Number: NCT07415447

Cardiac Remodelling Following Endovascular Repair of the Aorta

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

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Key information

Conditions

Cardiac Failure Aortic Disease Aortic Diseases Cardiovascular Diseases Disease Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Unidade Local de Saúde Santa Maria, Lisbon, Portugal

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About this study

After being informed about the study and potential risks, all patients giving written informed consent will undergo a pre-surgery evaluation: clinical evaluation, blood sampling, CT-scan, echocardiography and cardiac magnetic resonance.

The same evaluation will be performed at 6- and 12-months post-surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

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.

    Time frame: 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.

Secondary outcomes

  1. 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.

    Time frame: 6-month period

    The cardiac remodelling will be estimated through the variables of left ventricular mass/volume/strain at baseline and 6 months, measured in grams/mililiters/percentage through CMR and ECHO.

  2. 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.

    Time frame: 12-months period

    The cardiac remodelling will be estimated through the variables of left ventricular volume/strain at baseline and 12 months, measured in mililiters/percentage through CMR and ECHO.

  3. 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.

    Time frame: 6- and 12-months periods

    The cardiac remodelling will be estimated through the variables of left ventricular mass/volume/strain at baseline, 6 months and 12 months, measured in grams/mililiters/percentage through CMR and ECHO.

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

    Time frame: 12-month period

    The cardiac remodelling will be correlated with the proximity and extension of aortic endografts, measured in milimeters, throught the analysis of the previously described cardiac remodelling variables and the analysis of CT scans.

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

    Time frame: 6-month and 12-month periods

    The cardiac biomarker will be obtained thorught blood sample analysis at 6-months and 12-months, comprised by the following:

    Soluble suppression of tumorigenicity-2 (sST2). Collagen synthesis biomarkers (PICP, PINP, PIIINCP, PIIINP). Collagen type I degradation biomarker (CITP). B-type natriuretic peptide and terminal of the prohormone brain natriuretic peptide (BNP, NT-proBNP).

    High sensitivity C Reactive protein (hsCRP). Galectin 3 (Gal3). Fibroblast activation protein (FAP). Troponins (I and T). Proteinomic and metabolomic parameters

  6. To compare the agreement between measurements ECHO and CMR measurements.

    Time frame: 12-month period

  7. To evaluate trends in the patient's blood pressure profile as a possible first sign of the hemodynamic changes induced by EVAR.

    Time frame: 1-month, 6-months and 12-month period.

    The patient's blood pressure will be evaluated in clinical visits at 1-month, 6 months and 12 months, mesured em mmHg.

Study contacts

Contact information is provided by the study sponsor or research team.

Augusto Ministro Augusto Ministro

CONTACT

[email protected]

00531 210405814

Sponsors and collaborators

Lead sponsor

Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa

Network

Registry information

Acronym: EVACaRe

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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