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Status unknownNCT03310671Updated Oct 16, 2017

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

An observational study in Aortic Stenosis, Arteriosclerosis and Familial Hypercholesterolemia, sponsored by Instituto Aragones de Ciencias de la Salud. Status unknown at 1 site in Spain. Open to participants aged 55 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-16.

Sponsored by Instituto Aragones de Ciencias de la Salud · Observational

The sponsor has not verified this record recently (last verified Oct 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
900
Ages
55 Years and older
Sex
All
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Study 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

Read the 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.

02

Conditions studied

  • Aortic Stenosis
  • Arteriosclerosis
  • Familial Hypercholesterolemia
  • Conventional Transthoracic Echocardiogram
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In context

Aortic Valve Stenosis

1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.

This study's planned enrollment of 900 is above the median of 200 across 435 observational studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

Instituto Aragones de Ciencias de la Salud is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Personal history of cardiac rheumatic disease
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
900 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • 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

  • 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

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

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What researchers measure

Primary outcomes

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

    Time frame: 1 YEAR

Secondary outcomes

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

    Time frame: 1 YEAR

  2. Difference in aortic surface between cases and controls

    Time frame: 1 YEAR

  3. Difference in the mean transvalvular gradient between cases and controls

    Time frame: 1 YEAR

  4. Difference between maximum aortic jet velocity between cases and controls

    Time frame: 1 YEAR

07

Study locations

1 of 1 sites recruiting
  • Fernando Civeira Murillo
    Zaragoza, 50009, Spain
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03310671
Lead sponsor
Instituto Aragones de Ciencias de la Salud
Responsible party
Fernando Civeira (Instituto Aragonés de Ciencias de la Salud, Instituto Aragones de Ciencias de la Salud) — Principal investigator
First posted
Oct 16, 2017
Start date
Jul 18, 2017
Primary completion
Jul 18, 2018 (estimated)
Completion
Jul 18, 2018 (estimated)
Last update
Oct 16, 2017

Study contacts

Fernando Civeira
Contact
civeira@unizar.es
976765500 ext. 2884

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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