- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03310671
Aortic Stenosis in Subjects With Heterozygous Familial Hypercholesterolemia on Prolonged Treatment With Statins
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Fernando Civeira
- Phone Number: 2884 976765500
- Email: civeira@unizar.es
Study Locations
-
-
-
Zaragoza, Spain, 50009
- Recruiting
- Fernando Civeira Murillo
-
Contact:
- Victoria MARCO BENEDÍ, RD
- Phone Number: 2895 976765500
- Email: vmarcobenedi@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
CASES
Cases:
|
Conventional transthoracic echocardiogram by an echocardiographer trained to perform and centered on aortic valve Pick up from:
|
Controls
|
Conventional transthoracic echocardiogram by an echocardiographer trained to perform and centered on aortic valve Pick up from:
|
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Metabolic Diseases
- Arterial Occlusive Diseases
- Genetic Diseases, Inborn
- Pathological Conditions, Anatomical
- Aortic Valve Disease
- Heart Valve Diseases
- Ventricular Outflow Obstruction
- Metabolism, Inborn Errors
- Lipid Metabolism Disorders
- Hyperlipidemias
- Dyslipidemias
- Lipid Metabolism, Inborn Errors
- Hyperlipoproteinemias
- Aortic Valve Stenosis
- Hypercholesterolemia
- Arteriosclerosis
- Constriction, Pathologic
- Hyperlipoproteinemia Type II
Other Study ID Numbers
- C.I.PI17/0256
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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