Patients treated with statins for the first time Circulatory System
Conditions
Interventions
The randomization will be performed by a statistician, who will have no contact with the participants. The research team and participants will be unaware of the group assignments and the envelope with
Sponsors
Horphag Research (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with different diagnoses (e.g. CVD, hypertension) who will be treated with any type of statin for the first time and in a dose that will be determined individually based on the established overall CV risk with the aim of achieving target lipid values
Exclusion criteria
Exclusion criteria: 1. Aged 60 years old 2. Acute myocardial infarction (IM) or less than 3 months after IM 3. Active oncological disease 4. Hypothyroidism 5. Diabetes Mellitus 6. Chronic inflammatory disease (e.g. rheumatoid arthritis) 7. Unable/unwilling to sign an informed consent 8. Unable/unwilling to provide samples of biological material as needed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Quality of life and side symptoms of statin treatment measured using the 12-Item Short Form Survey (SF-12) questionnaire at baseline and after 3 months of intervention 2. CoQ10 levels in the blood HPLC at baseline and after 3 months of intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Basic and specific biochemical parameters - fasting glucose, creatinine, urea, lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol, TAG), CRP, apolipoprotein A1, lipoprotein(a) measured at certified Laboratory of Clinical Biochemistry using Roche tests at baseline and after 3 months of intervention 2. HDL and LDL subfractions measured using an electrophoretic Lipoprint system at baseline and after 3 months of intervention 3. Total antioxidant capacity of plasma measured using the TEAC method and the levels of selected antioxidants (alpha-tocopherol, gamma-tocopherol, beta-carotene, glutathione) in thrombocytes, blood and plasma measured using spectrophotometric or fluorometric methods at baseline and after 3 months of intervention 4. The parameters of oxidative damage to lipids (oxLDL, lipoperoxide, TBARS) in plasma measured using spectrophotometric methods at baseline and after 3 months of intervention 5. Activities of PON 1 (arylesterase and lactonase) using spectrophotometric methods at baseline and after 3 months of intervention 6. Activity of creatine kinase (isoenzyme MM) measured at certified Laboratory of Clinical Biochemistry at baseline and after 3 months of intervention | — |
Countries
Slovakia
Contacts
Public ContactInstitute of Medical Chemistry Biochemistry and Clinical Biochemistry
Outcome results
None listed