Clinical trial NCT03310671: Aortic Stenosis in Subjects With Heterozygous Familial Hypercholesterolemia on Prolonged Treatment With Statins
Official title: Aortic Stenosis in Subjects With Heterozygous Familial Hypercholesterolemia on Prolonged Treatment With Statins
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Stenosis
Arteriosclerosis
Familial Hypercholesterolemia
Conventional Transthoracic Echocardiogram
Lead sponsor: Instituto Aragones de Ciencias de la Salud
Sponsor class: OTHER_GOV
First posted: 2017-10-16
Enrollment: 900
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Differences in age-adjusted prevalence of EA assessed by transthoracic echocardiography between cases and controls
timeFrame: 1 YEAR
Secondary outcomes:
measure: Differences in age-adjusted prevalence of AD assessed by transthoracic echocardiography between cases and controls
timeFrame: 1 YEAR
measure: Difference in aortic surface between cases and controls
timeFrame: 1 YEAR
measure: Difference in the mean transvalvular gradient between cases and controls
timeFrame: 1 YEAR
measure: Difference between maximum aortic jet velocity between cases and controls
timeFrame: 1 YEAR
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Fernando Civeira Murillo
Study officials:
References: