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

Instituto Aragones de Ciencias de la Salud

Status: Unknown

Conditions: Conventional Transthoracic Echocardiogram; Arteriosclerosis; Aortic Stenosis; Familial Hypercholesterolemia

Treatments: Procedure: Echocardiogram

Study type: Observational

Funder types: Other

Identifiers

NCT03310671

C.I.PI17/0256

Details and patient eligibility

About

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

Full 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.

Enrollment: 900 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

900 participants in 2 patient groups

CASES

Description:

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

Treatment:

Procedure: Echocardiogram

Controls

Description:

* 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

Treatment:

Procedure: Echocardiogram