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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03310671
Other study ID # C.I.PI17/0256
Secondary ID
Status Recruiting
Phase N/A
First received October 10, 2017
Last updated October 10, 2017
Start date July 18, 2017
Est. completion date July 18, 2018

Study information

Verified date October 2017
Source Instituto Aragones de Ciencias de la Salud
Contact Fernando Civeira
Phone 976765500
Email civeira@unizar.es
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Aortic stenosis (AE) is a disease that has been increasing steadily in recent years in most countries, including Spain.Risk factors for the development of AE include age, hypercholesterolemia, diabetes mellitus and arterial hypertension, the classic risk factors for the development of atherosclerosis. However, lipid-lowering therapy with statins and ezetimibe has not been shown to reduce the risk of long-term progression of AE by unknown mechanisms. All this suggests that subjects with HFhe have a high risk of developing AD, which has not been shown by the high coronary mortality in this population that precedes aortic calcification


Description:

The study includes a single clinical visit with collection of clinical data, blood extraction and the performance of a transthoracic echocardiogram. This visit may be made on different days, but always within 30 days of signing the informed consent.


Recruitment information / eligibility

Status Recruiting
Enrollment 900
Est. completion date July 18, 2018
Est. primary completion date July 18, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years and older
Eligibility Inclusion Criteria:

Cases:

- Age = 65 years at the time of cardiac ultrasound

- Genetically diagnosed HFH or in a first-degree relative

- History of hypercholesterolemia with LDLc levels> 220 mg / dL without lipid-lowering treatment

Controls:

- Genetically Similar

- Siblings of the normoccholesterolemic case, defined by LDLc <190 mg / dl without lipid-lowering treatment.

- In the absence of available siblings, first cousins may be included.

- In the presence of several siblings available, the same sex will be included,

- Environmentally similar

- Stable partner of the case with cohabitation> 25 years * Each case will have at least one control.

Exclusion Criteria:

- Personal history of cardiac rheumatic disease

Study Design


Intervention

Procedure:
Echocardiogram
Conventional transthoracic echocardiogram by an echocardiographer trained to perform and centered on aortic valve Pick up from: Mean transvalvular pressure gradient Aortic valve Aortic valve opening area Aortic valve opening area adjusted for body mass index Bicuspid or tricuspid aorta Thickness of the upper valve> 3 mm

Locations

Country Name City State
Spain Fernando Civeira Murillo Zaragoza

Sponsors (1)

Lead Sponsor Collaborator
Instituto Aragones de Ciencias de la Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Differences in age-adjusted prevalence of EA assessed by transthoracic echocardiography between cases and controls 1 YEAR
Secondary Differences in age-adjusted prevalence of AD assessed by transthoracic echocardiography between cases and controls 1 YEAR
Secondary Difference in aortic surface between cases and controls 1 YEAR
Secondary Difference in the mean transvalvular gradient between cases and controls 1 YEAR
Secondary Difference between maximum aortic jet velocity between cases and controls 1 YEAR
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