Treatment Rates and Compliance to Treatment in Patients With Familial Hypercholesterolemia

Completed

• Conditions: Familial Hypercholesterolemia
• Interventions: Other: No intervention

• Registration Number: NCT04494464
• Lead Sponsor: Ankara Yildirim Beyazıt University

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.

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 Timeline

• Study Start: 2017-01
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2020-07
• Study First Submitted: 2020-07-24
• Study First Submitted QC: 2020-07-28
• Last Update Submitted: 2020-07-28
• Study First Posted: 2020-07-31
• Last Update Posted: 2020-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 367

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with LDL cholesterol ≥250 mg/dL	No intervention	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.

Primary Outcome Measures

Name	Time	Method
Treatment rates	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