Familial Hypercholesterolemia in Turkey (A-HIT2)

NCT ID: NCT03110250

Last Updated: 2017-12-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-26
• Study Completion Date: 2017-12-05

Brief Summary

A-HIT2, is also designed as a National FH registry. At least 1000 FH patients will be recruited from 30 outpatient clinics representing the 12 Nuts statistical Regions in Turkey proportional to the 2015 Turkey's Population distribution.[14] Both HeFH and HoFH patients are eligible for enrollment. Sites specialized on cardiology, internal medicine, and endocrinology were invited by the Turkish Society of Cardiology.

Detailed Description

At least 1000 FH patients will be recruited from 30 outpatient clinics representing the 12 Nuts statistical Regions in Turkey proportional to the 2015 Turkey's Population distribution. Both HeFH and HoFH patients are eligible for enrollment. Sites specialized on cardiology, internal medicine, and endocrinology were invited by the Turkish Society of Cardiology. The primary objective of this cross-sectional study, is to detect the clinical status and management of the patients diagnosed with FH in Turkey. The secondary objectives are; to detect the pattern of clinical presentation, to know the medication use, to define the clinical response to LLT, to evaluate the attainment of LDL-cholesterol goals and to identify resistance and/or intolerance to LLT. Defining the CV risk factors and approach to these factors by the physicians, and comparing the attitudes in different specialty groups (cardiology, endocrinology and internal medicine) are also among the secondary objectives of the registry. Eligibility for screening was defined as having LDL-cholesterol levels > 160 mg/dl either as on treatment or untreated values. Centers may enroll both incident and prevalent patients. The inclusion criteria included age > 18 years and being diagnosed as possible FH. The possible FH was defined as having a total score of > 2 according to Dutch lipid clinic network (DLCN) criteria. Patients with triglyceride levels > 400 mg/dl or secondary hyperlipidemia (ie, untreated hypothyroidism, nephrotic syndrome, cholestasis, etc..) will be excluded from the study. Two different data sets will be collected for A-HIT2. The physicians will complete electronic case report forms for each patient Patients will also complete a short survey to assess the level of disease awareness. This survey is also designed to give information on the patients' perceptions and knowledge on cholesterol, its harm, and LLT. All data will be collected in a single visit. Data verification will be based on the source document control of 5% sample randomly selected per center.

Conditions

Familial Hypercholesterolemia; Atherosclerosis

Keywords

Familial Hypercholesterolemia; registry; Turkey; Lipid lowering therapy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• age > 18 years and being diagnosed as possible FH.
• The possible FH was defined as having a total score of > 2 according to Dutch lipid clinic network (DLCN) criteria

Exclusion Criteria

• Patients with triglyceride levels > 400 mg/dl or secondary hyperlipidemia (ie, untreated hypothyroidism, nephrotic syndrome, cholestasis, etc..) will be excluded from the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Turkish Society of Cardiology

OTHER

Sponsor Role: collaborator

Ege University

OTHER

Sponsor Role: lead

Responsible Party

Meral Kayikcioglu

Professor MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Meral Kayikcioglu

Role: PRINCIPAL_INVESTIGATOR

Ege University

Locations

Ege University Medical School

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

A-HIT2

Identifier Type: -

Identifier Source: org_study_id