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

Aortic Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03310671
• Other study ID #: C.I.PI17/0256
• 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
• 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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Arteriosclerosis
• Constriction, Pathologic
• Conventional Transthoracic Echocardiogram
• Familial Hypercholesterolemia
• Hypercholesterolemia
• Hyperlipoproteinemia Type II

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