Familial hypercholesterolemia
Conditions
Interventions
In addition to usual familial hypercholesterolemia (FH) patients'
education, we perform genetic tests for genes associated with FH (LDLR, PCSK9, APOB, and LDLRAP1), and individual genetic counseling regarding the genetic test result and his/her future cardiovascular
education
Sponsors
Kanazawa University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosed with familial hypercholesterolemia by criteria from the Japan Atherosclerosis Society. 2) Patients who have never got genetic tests, or have not yet returned genetic results regarding familial hypercholesterolemia. 3) Patients who can provide written informed consent
Exclusion criteria
Exclusion criteria: 1) Liver dysfunction (AST or ALT > 3 times the UNL) 2) Renal dysfunction (Cr 2.0 mg/dL or greater) 3) Immunosuppression 4) Active cancer 5) Previous history of coronary heart disease: i) Myocardial infarction ii) History of percutaneous coronary intervention iii) Coronary stenosis (75% or greater) previously detected by coronary angiography 6) Female with pregnancy or expected 7) Patients whose doctors in charge consider him/her inappropriate to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LDL cholesterol levels at 24 weeks after randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood test results (total cholesterol, triglyceride, HDL-C, LDL-C, FBG, HbA1C, WBC, RBC, Hemoglobin, Hematocrit, Platelet, ALT, AST, gamma GTP, ALP, T-Bil. Cr, BUN. TP, Alb, UA, Na, K, Cl, Ca, P, hsCRP), smoking habit, drug adherence, and patient satisfaction questionnaire (PSQ-18) score at 24 and 48 weeks after randomization between intervention/control and/or genetic test positive / negative groups. | — |
Countries
Japan
Contacts
Public ContactAkihiro Nomura
Kanazawa University Innovative Clinical Research Center (iCREK)
Outcome results
None listed