Familial Hypercholesterolemia in Turkey (A-HIT2)

Atherosclerosis Clinical Trial

— A-HIT2  

Official title:

A Nation-wide Registry of Familial Hypercholesterolemia : Clinical Status in Turkey (A-HIT2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03110250
• Other study ID #: A-HIT2
• Status: Completed
• Phase: N/A
• First received: April 3, 2017
• Last updated: December 5, 2017
• Start date: February 26, 2017
• Est. completion date: December 5, 2017

Study information

• Verified date: December 2017
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: December 5, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Familial Hypercholesterolemia
• Hypercholesterolemia
• Hyperlipoproteinemia Type II

Locations

Country	Name	City	State
Turkey	Ege University Medical School	Izmir

Sponsors (2)

Lead Sponsor	Collaborator
Ege University	Turkish Society of Cardiology

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients receiving proper treatment for FH	how many patients are receieving the proper lipid lowering drugs for the diagnosis of FH	February- November 2017
Secondary	number of patients reaching LDL-cholesterol goal according to risk status (risk level)	how patients diagnosed with FH in Turkey are managed, that is to what percent they reach ldl goals.	February- November 2017