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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03280433
Other study ID # SFRH/BD/104369/2014
Secondary ID
Status Recruiting
Phase N/A
First received September 8, 2017
Last updated September 13, 2017
Start date September 1, 2014
Est. completion date November 25, 2018

Study information

Verified date September 2017
Source Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Contact Jennifer Mancio, MD, PhD candidate
Phone 00351961529516
Email jennifer.mancio@cardiov.ox.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This translational study was designed to explore the association of the quantity and quality of epicardial adipose tissue (EAT) with coronary artery disease (CAD), left atrial remodeling and postoperative atrial fibrillation in a high cardiovascular disease-risk population. The investigators expect to identify new biochemical factors and biomarkers in the crosstalk between the epicardial adipocytes, coronary plaques and atrial cardiomyocytes that are involved in the pathogenesis of atherosclerosis and atrial fibrillation, respectively.


Description:

Background: EAT has emerged as a new independent, and, potentially, modifiable cardiovascular risk factor for CAD. EAT volume assessed by computed tomography (CT) was independently associated with the presence of coronary stenosis, coronary calcification and myocardial ischemia in cross-sectional studies, and, prospectively, with major adverse cardiovascular events. Most of these clinical studies were, however, derived from community-based patients with low-to intermediate-risk profile and the role of EAT in high-risk patients is currently unclear. Accumulation of EAT has been also associated with left atrial (LA) dilation, presence, chronicity, and recurrence of atrial fibrillation (AF). Although there is evidence suggesting that EAT may be a major determinant of the LA vulnerable substrate of AF, the mechanisms in the causal pathway between the EAT and LA remodeling are not completely elucidated.

Aims: The main aims are to investigate if the volume of the EAT on CT and EAT proteome assessed by SWATH-mass spectrometry are associated with extent, distribution and complexity of coronary stenosis and coronary artery calcification, left atrial strain and incidence of postoperative atrial fibrillation in patients with symptomatic severe aortic stenosis.

Methods: This a prospective study enrolling symptomatic severe aortic stenosis patients referred to aortic valve replacement. The protocol includes preoperative detailed clinical and nutritional evaluations, echocardiography, CT, cardiac magnetic resonance imaging and invasive coronary angiography. During cardiac surgery, biopsies from the EAT, mediastinal and subcutaneous thoracic adipose tissues will be performed to undergo analysis of proteome using SWAT-mass spectrometry. Samples from the pericardial fluid, circulating and coronary sinus blood samples will be collected as well in order to find local and peripheral adipose tissue-derived biomarkers of the disease.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date November 25, 2018
Est. primary completion date November 25, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- symptomatic severe aortic stenosis patients (defined as aortic valve area of < 1 cm2 or 0.6 cm2/m2 by transthoracic echocardiography) referred to aortic valve replacement.

Exclusion Criteria:

- diagnosis of acute coronary syndrome in the last 3 months.

- prior history of persistent or permanent atrial or flutter fibrillation.

- coexisting moderate to severe aortic valve regurgitation or moderate to severe mitral valve disease, bicuspid aortic valve.

- left ventricular dilatation [end-diastolic volume index >75 mL/m²].

- left ventricular ejection fraction <55%.

- chronic renal failure stage 3 to 5 defined as glomerular filtration rate GFR estimated by Cockcroft-Gault formula adjusted for body surface area < 30 mL/min/1.73m².

- moderate to severe chronic obstructive pulmonary disease defined as forced expiratory volume in one second <50% according to the 2011 Global Initiative for Chronic Obstructive Pulmonary Disease guidelines.

- active malignancy (i.e. With no evidence of recurrence and no longer receiving active treatment).

Study Design


Intervention

Other:
Aortic valve replacement


Locations

Country Name City State
Portugal Faculty of Medicine of Porto Porto
Portugal Centro Hospitalar de Vila Nova de Gaia/Espinho Vila Nova de Gaia Porto

Sponsors (2)

Lead Sponsor Collaborator
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E. Universidade do Porto

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Other Mortality Incidence of all-cause death after aortic valve replacement 3- to 5-year after aortic valve replacement
Primary New onset atrial fibrillation Incidence of atrial fibrillation after aortic valve replacement Intra-hospital (i.e. from surgery until hospital discharge which means 7 days on average)
Primary Left atrial remodelling by transthoracic echocardiography and magnetic resonance imaging Change in left atrial strain and volumes 6-month following aortic valve replacement
Primary Frailty syndrome according to Fried et al. scale Change in frailty syndrome classification 6-month following aortic valve replacement
Primary Coronary artery disease according to the presence of coronary stenosis and/or calcification Prevalent coronary artery stenosis and coronary calcification Baseline
Secondary Left ventricular hypertrophy by transthoracic echocardiography and magnetic resonance imaging Regression of left ventricular mass after aortic valve replacement 6-month following aortic valve replacement
Secondary Right ventricular structure and function by transthoracic echocardiography and magnetic resonance imaging Changes in right ventricular structure and function after aortic valve replacement 6-month following aortic valve replacement
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