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

NCT03310671 | Unknown

• 1 other identifier: C.I.PI17/0256
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

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

Conditions

Aortic Stenosis; Arteriosclerosis; Familial Hypercholesterolemia; Conventional Transthoracic Echocardiogram

Outcome Measures

Primary Outcomes (1)

• Differences in age-adjusted prevalence of EA assessed by transthoracic echocardiography between cases and controls

  1 YEAR

Secondary Outcomes (4)

• Differences in age-adjusted prevalence of AD assessed by transthoracic echocardiography between cases and controls

  1 YEAR

• Difference in aortic surface between cases and controls

  1 YEAR

• Difference in the mean transvalvular gradient between cases and controls

  1 YEAR

• Difference between maximum aortic jet velocity between cases and controls

  1 YEAR

Study Arms (2)

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

Procedure: Echocardiogram

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

Procedure: Echocardiogram

Interventions

Echocardiogram 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

CASES; Controls

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Genetically diagnosed HFH or in a first-degree relative \- History of hypercholesterolemia with LDLc levels\> 220 mg / dL without lipid-lowering treatment

You may qualify if:

• 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.

You may not qualify if:

• \- Personal history of cardiac rheumatic disease

Sponsors & Collaborators

• Instituto Aragones de Ciencias de la Salud: lead

Study Sites (1)

Fernando Civeira Murillo

Zaragoza, 50009, Spain

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis; Arteriosclerosis; Hyperlipoproteinemia Type II

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Arterial Occlusive Diseases; Vascular Diseases; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Fernando Civeira

CONTACT

976765500; civeira@unizar.es

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instituto Aragonés de Ciencias de la Salud

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: October 16, 2017
• Study Start: July 18, 2017
• Primary Completion: July 18, 2018
• Study Completion: July 18, 2018
• Last Updated: October 16, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)