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Aortic Stenosis in Subjects With Heterozygous Familial Hypercholesterolemia on Prolonged Treatment With Statins

NCT ID: NCT03310671

Last Updated: 2017-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-18

Study Completion Date

2018-07-18

Brief Summary

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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

Detailed Description

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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.

Conditions

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Aortic Stenosis Arteriosclerosis Familial Hypercholesterolemia Conventional Transthoracic Echocardiogram

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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CASES

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

Echocardiogram

Intervention Type PROCEDURE

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

Controls

* Genetically Similar
* Siblings of the normocholesterolemic 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

Echocardiogram

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Aragones de Ciencias de la Salud

OTHER_GOV

Sponsor Role lead

Responsible Party

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Fernando Civeira

Instituto Aragonés de Ciencias de la Salud

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fernando Civeira Murillo

Zaragoza, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Fernando Civeira

Role: CONTACT

Phone: 976765500

Email: [email protected]

Facility Contacts

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Victoria MARCO BENEDÍ, RD

Role: primary

Other Identifiers

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C.I.PI17/0256

Identifier Type: -

Identifier Source: org_study_id