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Trial record 74 of 153 for:    "familial hypercholesterolemia"

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

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ClinicalTrials.gov Identifier: NCT03310671
Recruitment Status : Recruiting
First Posted : October 16, 2017
Last Update Posted : October 16, 2017
Sponsor:
Information provided by (Responsible Party):
Fernando Civeira, Instituto Aragones de Ciencias de la Salud

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
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 Type : Observational [Patient Registry]
Estimated Enrollment : 900 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Aortic Stenosis in Subjects With Heterozygous Familial Hypercholesterolemia on Prolonged Treatment With Statins
Actual Study Start Date : July 18, 2017
Estimated Primary Completion Date : July 18, 2018
Estimated Study Completion Date : July 18, 2018


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
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




Primary Outcome Measures :
  1. Differences in age-adjusted prevalence of EA assessed by transthoracic echocardiography between cases and controls [ Time Frame: 1 YEAR ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03310671


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

Locations
Spain
Fernando Civeira Murillo Recruiting
Zaragoza, Spain, 50009
Contact: Victoria MARCO BENEDÍ, RD    976765500 ext 2895    vmarcobenedi@gmail.com   
Sponsors and Collaborators
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
ClinicalTrials.gov Identifier: NCT03310671     History of Changes
Other Study ID Numbers: C.I.PI17/0256
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: October 16, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
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:
Constriction, Pathologic
Hypercholesterolemia
Aortic Valve Stenosis
Hyperlipoproteinemia Type II
Arteriosclerosis
Pathological Conditions, Anatomical
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias
Arterial Occlusive Diseases
Vascular Diseases