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

• Conditions: Familial Hypercholesterolemia; Conventional Transthoracic Echocardiogram; Aortic Stenosis; Arteriosclerosis
• Interventions: Procedure: Echocardiogram

• Registration Number: NCT03310671
• Lead Sponsor: Instituto Aragones de Ciencias de la Salud

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2017-07-18
• Status Verified: 2017-10
• Study First Submitted: 2017-10-10
• Study First Submitted QC: 2017-10-10
• Last Update Submitted: 2017-10-10
• Study First Posted: 2017-10-16
• Last Update Posted: 2017-10-16
• Primary Completion: 2018-07-18
• Study Completion: 2018-07-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 900

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CASES	Echocardiogram	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	Echocardiogram	* 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

Primary Outcome Measures

Name	Time	Method
Differences in age-adjusted prevalence of EA assessed by transthoracic echocardiography between cases and controls	1 YEAR

Secondary Outcome Measures

Name	Time	Method
Difference in aortic surface between cases and controls	1 YEAR
Difference in the mean transvalvular gradient between cases and controls	1 YEAR
Differences in age-adjusted prevalence of AD assessed by transthoracic echocardiography between cases and controls	1 YEAR
Difference between maximum aortic jet velocity between cases and controls	1 YEAR

Trial Locations

Locations (1)

Fernando Civeira Murillo; 🇪🇸 Zaragoza, Spain