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

October 10, 2017 updated by: Fernando Civeira, Instituto Aragones de Ciencias de la Salud
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

Study Overview

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 Type

Observational

Enrollment (Anticipated)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Zaragoza, Spain, 50009
        • Recruiting
        • Fernando Civeira Murillo
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Differences in age-adjusted prevalence of EA assessed by transthoracic echocardiography between cases and controls
Time Frame: 1 YEAR
1 YEAR

Secondary Outcome Measures

Outcome Measure
Time Frame
Differences in age-adjusted prevalence of AD assessed by transthoracic echocardiography between cases and controls
Time Frame: 1 YEAR
1 YEAR
Difference in aortic surface between cases and controls
Time Frame: 1 YEAR
1 YEAR
Difference in the mean transvalvular gradient between cases and controls
Time Frame: 1 YEAR
1 YEAR
Difference between maximum aortic jet velocity between cases and controls
Time Frame: 1 YEAR
1 YEAR

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2017

Primary Completion (Anticipated)

July 18, 2018

Study Completion (Anticipated)

July 18, 2018

Study Registration Dates

First Submitted

October 10, 2017

First Submitted That Met QC Criteria

October 10, 2017

First Posted (Actual)

October 16, 2017

Study Record Updates

Last Update Posted (Actual)

October 16, 2017

Last Update Submitted That Met QC Criteria

October 10, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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