Subclinical Atherosclerosis in Patients With Familial Hypercholesterolemia Treated With Evolocumab®

Launched by FEDERICO II UNIVERSITY · Mar 17, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called Evolocumab® on patients with a genetic condition known as familial hypercholesterolemia (FH), which causes very high cholesterol levels. The researchers want to see how this treatment can improve cholesterol levels and reduce early signs of heart disease over a period of 12 weeks. They are particularly interested in measuring changes in cholesterol levels and some specific markers in the blood that indicate heart health.

To participate in the trial, individuals must be diagnosed with FH and meet certain health criteria outlined by the European Society of Cardiology. This means they should be starting treatment with a PCSK-9 inhibitor like Evolocumab® according to the latest guidelines. Eligible participants will be aged 65 to 74 and will need to understand and agree to be part of the study. Those with certain health issues, such as severe liver problems or high triglycerides, or those who have had cancer recently, cannot join the trial. Participants can expect regular check-ups and tests during the trial to monitor their health and the effects of the treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • diagnosis of FH (clinical and/or genetic)
• • eligibility of patients to start a treatment with PCSK-9 according to 2016 ESC guidelines.
• Exclusion Criteria:
• • 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.)