Subclinical Atherosclerosis in Patients With Familial Hypercholesterolemia Treated With Evolocumab®

NCT04313270 | Unknown FDA Drug

• 1 other identifier: 2015/261
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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 lipid profile, oxidation markers and subclinical atherosclerosis in patients with familial hypercholesterolemia (FH) during 12 weeks of treatment with a PCSK-9 inhibitor, Evolocumab®.

Conditions

Hypercholesterolemia, Familial

Outcome Measures

Primary Outcomes (1)

• Subclinical atherosclerosis

  evaluation of subclinical atherosclerosis in patients receiving Evolocumab

  12 weeks

Study Arms (1)

Patients with FH starting a treatment with Evolocumab®

Drug: Evolocumab

Interventions

Evolocumab DRUG

12 weeks of treatment with Evolocumab

Patients with FH starting a treatment with Evolocumab®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

consecutive patients attending the lipid clinic of the Department of Clinical Medicine and Surgery, Federico II University Hospital with very high levels of LDL-C (above the 95th percentile when compared with a sex- and age-matched general population), normal triglyceride levels and presumed autosomal dominant transmission of hypercholesterolemia in the family were screened for inclusion in the present study

You may qualify if:

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Matteo Di Minno

Napoli, 80131, Italy

RECRUITING

Related Publications (1)

• Iannuzzo G, Buonaiuto A, Calcaterra I, Gentile M, Forte F, Tripaldella M, Di Taranto MD, Giacobbe C, Fortunato G, Rubba PO, Di Minno MND. Association between causative mutations and response to PCSK9 inhibitor therapy in subjects with familial hypercholesterolemia: A single center real-world study. Nutr Metab Cardiovasc Dis. 2022 Mar;32(3):684-691. doi: 10.1016/j.numecd.2021.10.025. Epub 2021 Nov 11.

  PMID: 34991937 DERIVED

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Interventions

evolocumab

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Study Record Dates

• First Submitted: March 15, 2020
• First Posted: March 18, 2020
• Study Start: December 1, 2017
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2025
• Last Updated: March 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)