Status:
UNKNOWN
Subclinical Atherosclerosis in Patients With Familial Hypercholesterolemia Treated With Evolocumab®
Lead Sponsor:
Federico II University
Conditions:
Hypercholesterolemia, Familial
Eligibility:
All Genders
18+ years
Brief Summary
Protein convertase subtilisin kexin type 9 (PCSK-9) inhibitors demonstrated efficacy in cholesterol reduction and in the prevention of cardiovascular events. The investigators will evaluate changes in...
Detailed Description
Several studies emphasize the role of high levels of low-density lipoprotein cholesterol (LDL-C) as the main causative factor in atherosclerosis development. Among patients with hypercholesterolemia, ...
Eligibility Criteria
Inclusion
- diagnosis of FH (clinical and/or genetic)
- eligibility of patients to start a treatment with PCSK-9 according to 2016 ESC guidelines.
Exclusion
- age \< 18 years
- inability to understand or sign the informed consent
- high level of transaminases ( \>3x upper normal limit)
- hypertriglyceridemia ( \>150 mg/dl)
- end-stage renal disease (filtration rate \< 30 ml/min/mq)
- current malignant disease or a diagnosis of malignancy in the 2 years prior to the first visit
- previous exposure to PCSK-9 inhibitors
- presence of hypercholesterolemia secondary to other causes (hypothyroidism, hormone therapies, corticosteroids etc.)
Key Trial Info
Start Date :
December 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04313270
Start Date
December 1 2017
End Date
December 1 2025
Last Update
March 8 2021
Active Locations (1)
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1
Matteo Di Minno
Napoli, Italy, 80131