Cardiac Remodelling Following Endovascular Repair of the Aorta
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLisbon Academic Medical Center - Centro Académico de Medicina de Lisboa
About this trial
To assess the effects of endovascular aortic repair on cardiac morphology and function
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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.
Trial 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).
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
cardiac magnetic ressonance
Diagnostic testIn patients with aortic disease submitted to endovascular repair, will be studied through cardiac magnetic ressonance to evaluate cardiac function
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Participants submitted to aortic repair1 intervention
Trial outcomes
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 periodSecondary 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 period2
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 period3
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 periods4
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 periodSponsors and contacts
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Source ClinicalTrials.gov