Aortic StenosisNCT03310671
Aortic Stenosis in Subjects With Heterozygous Familial Hypercholesterolemia on Prolonged Treatment With Statins
An observational study of Aortic Stenosis and Arteriosclerosis, run by Instituto Aragones de Ciencias de la Salud at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aortic Stenosis, Arteriosclerosis, Familial Hypercholesterolemia
- What is being tested?
- Echocardiogram
- Type of treatment
- Surgery or procedure
- How many people
- 900 participants
- Where
- 1 siteSpain
- Study dates
- 18 Jul 2017to 18 Jul 2018
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Genetically diagnosed HFH or in a first-degree relative - History of hypercholesterolemia with LDLc levels> 220 mg / dL without lipid-lowering treatment
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- Personal history of cardiac rheumatic disease
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Fernando Civeira Murillo
Zaragoza, 50009
Victoria MARCO BENEDÍ, RD, 976765500 ext. 2895, vmarcobenedi@gmail.com
About this study
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.
- Conditions
- Aortic Stenosis, Arteriosclerosis, Familial Hypercholesterolemia, Conventional Transthoracic Echocardiogram
- Being tested
- Echocardiogram
- Medical subject headings
- Aortic Valve Stenosis, Arteriosclerosis, Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiogramProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Echocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in age-adjusted prevalence of EA assessed by transthoracic echocardiography between cases and controls
Measured: 1 YEAR
Secondary outcomes (4)
Differences in age-adjusted prevalence of AD assessed by transthoracic echocardiography between cases and controls
Measured: 1 YEAR
Difference in aortic surface between cases and controls
Measured: 1 YEAR
Difference in the mean transvalvular gradient between cases and controls
Measured: 1 YEAR
Difference between maximum aortic jet velocity between cases and controls
Measured: 1 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start18 Jul 2017
- Primary completion18 Jul 2018 (estimated)
- Study completion18 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Instituto Aragones de Ciencias de la Salud
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fernando Civeira, Instituto Aragones de Ciencias de la Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310671
- Sponsor's protocol ID
- C.I.PI17/0256
- Status last verified
- Oct 2017
- First submitted
- 10 Oct 2017
- Last updated
- 16 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aortic Stenosis in Subjects With Heterozygous Familial Hypercholesterolemia on Prolonged Treatment With Statins
- ClinicalTrials.gov ID
- NCT03310671
- Acronym / sponsor ID
- C.I.PI17/0256
- Conditions
- Aortic Stenosis, Arteriosclerosis, Familial Hypercholesterolemia, Conventional Transthoracic Echocardiogram
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Instituto Aragones de Ciencias de la SaludOther government
- Study start
- 18 Jul 2017 (actual)
- Primary completion
- 18 Jul 2018 (estimated)
- Study completion
- 18 Jul 2018 (estimated)
- First posted
- 16 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CASES | – | Procedure: EchocardiogramCases: * 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 | – | Procedure: Echocardiogram* 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 |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Genetically diagnosed HFH or in a first-degree relative - History of hypercholesterolemia with LDLc levels> 220 mg / dL without lipid-lowering treatment
Key inclusion criteria (11 listed)
- 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
- Genetically Similar
- Siblings of the normoccholesterolemic case, defined by LDLc <190 mg / dl without lipid-lowering treatment.
Key exclusion criteria (1 listed)
- Personal history of cardiac rheumatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiogramConventional 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 | Procedure or surgery | CASES, Controls |
Primary outcome
Differences in age-adjusted prevalence of EA assessed by transthoracic echocardiography between cases and controls
Time frame: 1 YEAR
4 secondary outcomes
Differences in age-adjusted prevalence of AD assessed by transthoracic echocardiography between cases and controls
Time frame: 1 YEAR
Difference in aortic surface between cases and controls
Time frame: 1 YEAR
Difference in the mean transvalvular gradient between cases and controls
Time frame: 1 YEAR
Difference between maximum aortic jet velocity between cases and controls
Time frame: 1 YEAR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis and Arteriosclerosis, run by Instituto Aragones de Ciencias de la Salud at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernando Civeira (976765500 ext. 2884, civeira@unizar.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in age-adjusted prevalence of EA assessed by transthoracic echocardiography between cases and controls (time frame: 1 YEAR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2017.