Evaluating the effects of Evolocumab on cholesterol levels in patients with familial hypercholesterolemia
Subclinical Atherosclerosis in Patients With Familial Hypercholesterolemia Treated With Evolocumab®
This study is testing if the cholesterol-lowering drug Evolocumab can help people with familial hypercholesterolemia lower their cholesterol levels and improve their heart health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Federico II University Academic / other |
| Drugs / interventions | Evolocumab |
| Locations | 1 site (Napoli) |
| Trial ID | NCT04313270 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the impact of the PCSK-9 inhibitor Evolocumab on lipid profiles, oxidation markers, and subclinical atherosclerosis in patients diagnosed with familial hypercholesterolemia (FH). Over a 12-week treatment period, the study will assess changes in endothelial function and cardiovascular risk factors, particularly focusing on low-density lipoprotein cholesterol (LDL-C) levels. The research aims to provide insights into the effectiveness of Evolocumab in managing cholesterol levels and its potential benefits in reducing cardiovascular events among this high-risk population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with familial hypercholesterolemia who are eligible for treatment with PCSK-9 inhibitors.
Not a fit: Patients under 18 years old, those with secondary causes of hypercholesterolemia, or individuals with certain health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of cholesterol levels and reduced cardiovascular risk for patients with familial hypercholesterolemia.
How similar studies have performed: Previous studies have shown positive outcomes with PCSK-9 inhibitors in reducing LDL-C and cardiovascular events, indicating a promising approach in this area.
Eligibility criteria
Show full inclusion / exclusion 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.)
Where this trial is running
Napoli
- Matteo Di Minno — Napoli, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.