Cardiac Remodelling Following Endovascular Repair of the Aorta (EVACaRe)

February 12, 2026 updated by: Augusto Ministro, Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa
To assess the effects of endovascular aortic repair on cardiac morphology and function

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Portugal
      • Lisbon, Portugal, 1649-028
        • Recruiting
        • Unidade Local de Saude Santa Maria
        • Contact:
      • Lisbon, Portugal
        • Not yet recruiting
        • Unidade Local de Saúde de Santa Maria, E.P.E.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

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).

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Participants submitted to aortic repair
Participants submitted endovascular repair of the aorta
Diagnostic test: cardiac magnetic ressonance
In patients with aortic disease submitted to endovascular repair, will be studied through cardiac magnetic ressonance to evaluate cardiac function

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12-month period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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.
6- and 12-months periods
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.
12-month period
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-month and 12-month periods
To compare the agreement between measurements ECHO and CMR measurements.
Time Frame: 12-month period
12-month period
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.
1-month, 6-months and 12-month period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lisbon Academic Medical Center - Centro Académico de Medicina de Lisboa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023.15211.PEX

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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