Clinical trial NCT03110250: Familial Hypercholesterolemia in Turkey (A-HIT2)
Official title: A Nation-wide Registry of Familial Hypercholesterolemia : Clinical Status in Turkey (A-HIT2)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Familial Hypercholesterolemia
Atherosclerosis
Keywords: Familial Hypercholesterolemia
registry
Turkey
Lipid lowering therapy
Lead sponsor: Ege University
Sponsor class: OTHER
Collaborators: name: Turkish Society of Cardiology
First posted: 2017-04-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: At least 1000 Familial Hypercholesterolemia (FH) patients are being 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.

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.

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.

Primary outcomes:
measure: number of patients receiving proper treatment for FH
timeFrame: February- November 2017
Secondary outcomes:
measure: number of patients reaching LDL-cholesterol goal according to risk status (risk level)
timeFrame: February- November 2017
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University Medical School
Study officials:
affiliation: Ege University
name: Meral Kayikcioglu
role: PRINCIPAL_INVESTIGATOR
References: