NCT04494464

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
367

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 31, 2020

Completed
Last Updated

July 31, 2020

Status Verified

July 1, 2020

Enrollment Period

4 months

First QC Date

July 24, 2020

Last Update Submit

July 28, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    January 2010 and December 2016

Study Arms (1)

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.

Other: No intervention

Interventions

Patients with LDL cholesterol ≥250 mg/dL

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients older than 18 years old and have a serum LDL-C≥250 mg/dL

You may qualify if:

  • Patients older than 18 years old and have a serum LDL-C≥250 mg/dL

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemiasHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

July 24, 2020

First Posted

July 31, 2020

Study Start

January 1, 2017

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

July 31, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share