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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

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 2 months later.
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

In context

Heart Failure

6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.

This study's planned enrollment of 40 is below the median of 200 across 1,983 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa is the lead sponsor of 4 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 \<35 vs 50% or (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 ( \<30 mL/min/173 m2).
  • Moderate to severe pulmonary disease as indicate either by post bronchodilator (%predicted) \<50% or Modified Medical Research Council Dyspnoea Scale (mMRC) 3-4.
  • CMR (non-compatible pacemakers and metal implants, and claustrophobia).
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

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

06

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.

07

Study locations

1 of 2 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2025 (actual). Primary completion is estimated for Sep 2026, 12 months after the start.

Of 793 non-industry observational studies under Heart Failure, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 99. This study's planned 12 months is below that.

Counting every sponsor, half of 975 studies reached it within 41 months; a quarter within 23 and three quarters within 89.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 23, 2026
First posted
Feb 17, 2026
StartActual
Sep 1, 2025
Primary completionEst.
Sep 1, 2026
CompletionEst.
Sep 1, 2027
Last update
Feb 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

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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