Familial HypercholesterolemiaNCT04494464
Treatment Rates and Compliance to Treatment in Patients With Familial Hypercholesterolemia
An observational study of Familial Hypercholesterolemia, run by Ankara Yildirim Beyazıt University.
Trial summary
Familial hypercholesterolemia is a genetic disease characterized by increased levels of low density lipoprotein cholesterol (LDL-C). It is underdiagnosed and undertreated despite relatively high prevalence and significant association with increased mortality. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Familial Hypercholesterolemia
- How many people
- 367 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to May 2017
- How long will I take part?
- 1 Day
- 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 18 to 90 years
- All sexes
- Adult, Older adult
Study population: Patients older than 18 years old and have a serum LDL-C≥250 mg/dL
Who may be able to join
- Patients older than 18 years old and have a serum LDL-C≥250 mg/dL
Who cannot join
- Patients who refuse dto interview
- Serum TSH≥10 mIU/mL
- Glomerulonephritis or nephrotic syndrome
- ALT or AST higher than 3 times of normal limits
- Serum triglyceride >400 mg/dL
About this study
Official title: Awareness, Treatment Rates and Compliance to Treatment in Patients With Serum LDL Cholesterol Higher Than 250 mg/dL, and Possible, Probable or Definite Familial Hypercholesterolemia
Familial hypercholesterolemia is a genetic disease characterized by increased levels of low density lipoprotein cholesterol (LDL-C). It is underdiagnosed and undertreated despite relatively high prevalence and significant association with increased mortality.
Read the detailed description
Patients older than 18 years old and have a serum low density LDL-C≥250 mg/dL were identified from the hospital database. A questionnaire was completed via phone. Patients were classified as definite, probable and possible familial hypercholesterolemia according to Dutch Lipid Clinical Network Criteria
- Conditions
- Familial Hypercholesterolemia
- Being tested
- No intervention
- Medical subject headings
- Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with LDL cholesterol ≥250 mg/dL | Patients older than 18 years old and have a serum LDL-C≥250 mg/dL between January 2010 and December 2016. Patients with a serum TSH≥10 mIU/mL, patients with glomerulonephritis or nephrotic syndrome, patients with ALT or AST higher than 3 times of normal limits and patients with serum triglyceride >400 mg/dL were excluded. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment rates
Patients with a serum LDL-C≥250 mg/dL were identified from the database of our hospital. Dutch Lipid Clinical Network Criteria was used to classify patients as definite, probable and possible FH. Patients were reached by phone and a questionnaire was applied. The questionnaire consisted of questions related with clinical and physical examination findings defined in theDutch Lipid Clinical Network Criteria. Total cholesterol, LDL-C, HDL-C, triglyceride levels were obtained from the medical records. Patients were asked whether they were using lipid lowering drugs. If they were not using, the cause of this was asked. By this way, we determined the rate of use of lipid lowering drugs in patients with LDL-C≥250 mg/dL and have definite, probable or possible familial hypercholesterolemia
Measured: January 2010 and December 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study startJan 2017
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Familial HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 367 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Didem Ozdemir, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494464
- Sponsor's protocol ID
- Hypercholesterolemia
- Status last verified
- Jul 2020
- First submitted
- 24 Jul 2020
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yaman S, Ozdemir D, Akman BT, Cakir B, Ersoy O. Awareness, treatment rates, and compliance to treatment in patients with serum LDL cholesterol higher than 250 mg/dL, and possible, probable, or definite familial hypercholesterolemia. Postgrad Med. 2021 Mar;133(2):146-153. doi: 10.1080/00325481.2020.1805212. Epub 2020 Sep 23.
PubMed 32744105
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Awareness, Treatment Rates and Compliance to Treatment in Patients With Serum LDL Cholesterol Higher Than 250 mg/dL, and Possible, Probable or Definite Familial Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT04494464
- Acronym / sponsor ID
- Hypercholesterolemia
- Conditions
- Familial Hypercholesterolemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 367 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 31 Jul 2020 (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.
Familial hypercholesterolemia is a genetic disease characterized by increased levels of low density lipoprotein cholesterol (LDL-C). It is underdiagnosed and undertreated despite relatively high prevalence and significant association with increased mortality.
Detailed description
Patients older than 18 years old and have a serum low density LDL-C≥250 mg/dL were identified from the hospital database. A questionnaire was completed via phone. Patients were classified as definite, probable and possible familial hypercholesterolemia according to Dutch Lipid Clinical Network Criteria
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with LDL cholesterol ≥250 mg/dL | – | Other: No interventionPatients older than 18 years old and have a serum LDL-C≥250 mg/dL between January 2010 and December 2016. Patients with a serum TSH≥10 mIU/mL, patients with glomerulonephritis or nephrotic syndrome, patients with ALT or AST higher than 3 times of normal limits and patients with serum triglyceride >400 mg/dL were excluded. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18 years old and have a serum LDL-C≥250 mg/dL
Key inclusion criteria (1 listed)
- Patients older than 18 years old and have a serum LDL-C≥250 mg/dL
Key exclusion criteria (5 listed)
- Patients who refuse dto interview
- Serum TSH≥10 mIU/mL
- Glomerulonephritis or nephrotic syndrome
- ALT or AST higher than 3 times of normal limits
- Serum triglyceride >400 mg/dL
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 |
|---|---|---|
| No intervention | Other | Patients with LDL cholesterol ≥250 mg/dL |
Primary outcome
Treatment rates
Time frame: January 2010 and December 2016
Patients with a serum LDL-C≥250 mg/dL were identified from the database of our hospital. Dutch Lipid Clinical Network Criteria was used to classify patients as definite, probable and possible FH. Patients were reached by phone and a questionnaire was applied. The questionnaire consisted of questions related with clinical and physical examination findings defined in theDutch Lipid Clinical Network Criteria. Total cholesterol, LDL-C, HDL-C, triglyceride levels were obtained from the medical records. Patients were asked whether they were using lipid lowering drugs. If they were not using, the cause of this was asked. By this way, we determined the rate of use of lipid lowering drugs in patients with LDL-C≥250 mg/dL and have definite, probable or possible familial hypercholesterolemia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
- Derived from this study: PubMed 32744105Yaman S, Ozdemir D, Akman BT, Cakir B, Ersoy O. Awareness, treatment rates, and compliance to treatment in patients with serum LDL cholesterol higher than 250 mg/dL, and possible, probable, or definite familial hypercholesterolemia. Postgrad Med. 2021 Mar;133(2):146-153. doi: 10.1080/00325481.2020.1805212. Epub 2020 Sep 23.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Familial Hypercholesterolemia, run by Ankara Yildirim Beyazıt University.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment rates (time frame: January 2010 and December 2016). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04494464, which also lists 1 linked publication.
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 31 Jul 2020.