Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03310671
Enrollment
900
Registered
2017-10-16
Start date
2017-07-18
Completion date
2018-07-18
Last updated
2017-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis, Arteriosclerosis, Conventional Transthoracic Echocardiogram, Familial Hypercholesterolemia

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.

Interventions

PROCEDUREEchocardiogram

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

Sponsors

Instituto Aragones de Ciencias de la Salud
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Differences in age-adjusted prevalence of EA assessed by transthoracic echocardiography between cases and controls1 YEAR

Secondary

MeasureTime frame
Differences in age-adjusted prevalence of AD assessed by transthoracic echocardiography between cases and controls1 YEAR
Difference in aortic surface between cases and controls1 YEAR
Difference in the mean transvalvular gradient between cases and controls1 YEAR
Difference between maximum aortic jet velocity between cases and controls1 YEAR

Countries

Spain

Contacts

Primary ContactFernando Civeira
civeira@unizar.es976765500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026