Cardiac Remodelling Following Endovascular Repair of the Aorta (EVACaRe)

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

Study Overview

• Status: Recruiting
• Conditions: Aortic Disease; Cardiac Failure
• Intervention / Treatment: Diagnostic test: cardiac magnetic ressonance

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: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Augusto Ministro Augusto Ministro; Phone Number: 00531 210405814; Email: cic@ulssm.min-saude.pt

Study Locations

• Portugal
  • Lisbon, Portugal, 1649-028
    • Recruiting
    • Unidade Local de Saude Santa Maria
    • Contact: CIC; Phone Number: +351961948653; Email: CIC@ulssm.min-saude.pt
  • Lisbon, Portugal
    • Not yet recruiting
    • Unidade Local de Saúde de Santa Maria, E.P.E.

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

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.	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

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.	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.	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.	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.	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	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.		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.	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

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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: January 23, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: aortic; cardiac; disease; failure
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Pathological Conditions, Signs and Symptoms; Heart Failure; Disease; Aortic Diseases
• Other Study ID 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