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RecruitingNCT07415447EVACaReUpdated Feb 17, 2026

Cardiac Remodelling Following Endovascular Repair of the Aorta

An observational study in Cardiac Failure and Aortic Disease, sponsored by Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa. Recruiting at 2 sites in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-17.

Sponsored by Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Cardiac Failure
  • Aortic Disease

Keywords

  • cardiac
  • failure
  • aortic
  • disease
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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).

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

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).
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Participants submitted to aortic repair

    Participants submitted endovascular repair of the aorta

    Diagnostic Test: cardiac magnetic ressonance

Interventions

  • Diagnostic testcardiac magnetic ressonance

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

05

What researchers measure

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.

    Time frame: 12-month period

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.

    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.

    Time frame: 6-month period

  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.

    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.

    Time frame: 12-months period

  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.

    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.

    Time frame: 6- and 12-months periods

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

    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.

    Time frame: 12-month period

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

    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

    Time frame: 6-month and 12-month periods

  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.

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

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

06

Study locations

1 of 2 sites recruiting
  • 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
07

Registry details

Key details

Study ID
NCT07415447
Lead sponsor
Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa
Responsible party
Augusto Ministro (Principal Investigator, Academic and Clinical Professor, Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa) — Principal investigator
First posted
Feb 17, 2026
Start date
Sep 1, 2025
Primary completion
Sep 1, 2026 (estimated)
Completion
Sep 1, 2027 (estimated)
Last update
Feb 17, 2026

Study contacts

Augusto Ministro Augusto Ministro
Contact
cic@ulssm.min-saude.pt
00531 210405814

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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