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

• Sponsor: Instituto Aragones de Ciencias de la Salud (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03310671
• Collaborator: (none)
• Enrollment: 900
• Location: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 75.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Aortic Stenosis; Arteriosclerosis; Familial Hypercholesterolemia; Conventional Transthoracic Echocardiogram	Procedure: Echocardiogram

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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 900 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Aortic Stenosis in Subjects With Heterozygous Familial Hypercholesterolemia on Prolonged Treatment With Statins
• Actual Study Start Date: Jul 18, 2017
• Anticipated Primary Completion Date: Jul 18, 2018
• Anticipated Study Completion Date: Jul 18, 2018

Arms and Interventions

Arm	Intervention/Treatment
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; 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
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; 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

Outcome Measures

Primary Outcome Measures

1. Differences in age-adjusted prevalence of EA assessed by transthoracic echocardiography between cases and controls [1 YEAR]

Secondary Outcome Measures

1. Differences in age-adjusted prevalence of AD assessed by transthoracic echocardiography between cases and controls [1 YEAR]

2. Difference in aortic surface between cases and controls [1 YEAR]

3. Difference in the mean transvalvular gradient between cases and controls [1 YEAR]

4. Difference between maximum aortic jet velocity between cases and controls [1 YEAR]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fernando Civeira Murillo	Zaragoza		Spain	50009

Sponsors and Collaborators

• Instituto Aragones de Ciencias de la Salud

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fernando Civeira, Instituto Aragonés de Ciencias de la Salud, Instituto Aragones de Ciencias de la Salud
• ClinicalTrials.gov Identifier: NCT03310671
• Other Study ID Numbers: C.I.PI17/0256
• First Posted: Oct 16, 2017
• Last Update Posted: Oct 16, 2017
• Last Verified: Oct 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Aortic Valve Stenosis; Arteriosclerosis; Hyperlipoproteinemia Type II; Hypercholesterolemia; Constriction, Pathologic

Study Results

No Results Posted as of Oct 16, 2017