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Hypercholesterolemia, Familial clinical trials

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NCT ID: NCT06231459 Completed - Clinical trials for Hypercholesterolemia, Familial

Expression of Pro- and Anti-inflammatory Cytokines During Anti-PCSK9 in Familial Hypercholesterolemia

CytoEx-PCSK9
Start date: January 1, 2019
Phase: Phase 4
Study type: Interventional

Statins have been shown to reduce LDL cholesterol (LCLc) levels, stabilizing atheromatous plaque, reversing endothelial dysfunction and decreasing thrombogenesis. Novel pharmacological approaches, such as PCSK9 inhibitors (PCSK9i), effectively reduce LDL-c. In the clinical setting, there are cases of dyslipidemia showing lack of response to statin, known as statin-resistant familial hypercholesterolemia (SR-FH), where patients maintain a high cardiovascular risk despite statin therapy. Then, therapeutic alternatives are required. PCSK9i has shown to reduce cholesterol levels and risk of cardiovascular disease, particularly in patients with statin-resistant familial hypercholesterolemia; and recently, it has been hypothesized that PCSK9i have an effect on inflammation. Aim. To evaluate the effect of anti-PCSK9 treatment on markers related to the inflammatory response in patients with SR-FH. Methods. Non-randomized, non-controlled, before-after comparison, quasiexperimental, single-center study on patients older than 18 years, with diagnosis statin-resistant FH (SR-FH), who were attended at the Cardiology Department, Centro Médico Nacional "20 de Noviembre ISSSTE", Mexico City. SR-FH was defined as symptomatic cardiovascular disease accompanied by LDL-C concentration higher than 160 mg/dL despite maximally tolerated statin dose. Clinical-demographic and anthropometry data were collected during a direct interview. Blood sample was processed to obtain glycated hemoglobin complete blood count and serum lipids. Likewise, flow cytometry was used to characterize baseline circulating M1-, M2-macrophages and monocytes. Multiplexing of plasma samples was used to compare plasma fraktaline, IL-1, IL-4, IL-6, IL-8, IL-10, MCP-1 and TNF-alpha. Endpoints consisted of: 1) lower serum lipids; 2) modification of pro-inflammatory mediators (neutrophils, lymphocytes, NtLR, soluble pro-inflammatory cytokines). Quatitative data were resumed as mean ± SD; while categorical data as n(%).One-way T-test was applied. Statistical significance was considered if p <0.05.

NCT ID: NCT04837638 Active, not recruiting - Diet Habit Clinical Trials

Diet Quality and Coronary Artery Calcification in Adults With Heterozygous Familial Hypercholesterolemia

FH-CAC
Start date: July 1, 2021
Phase:
Study type: Observational

The overarching objective is to evaluate the relationship between diet and coronary artery calcification in patients with heterozygous familial hypercholesterolemia (HeFH). We will recruit adults with HeFH. They will have to complete questionnaires on diet, medication and lifestyle. Coronary artery calcification will be measured in each patient using a CT scan. Physiological and biochemical data will be collected.

NCT ID: NCT04722068 Completed - Clinical trials for Hypercholesterolemia, Familial

Regeneron 1331 Kinetics Sub-Study HoFH

Start date: October 7, 2016
Phase: N/A
Study type: Interventional

To evaluate the lipoprotein kinetics of subjects enrolled in the R1500-CL-1331 clinical trial (NCT02265952) to assess the mechanism by which the evinacumab may affect lipid levels in HoFH subjects.

NCT ID: NCT04656028 Recruiting - Clinical trials for Medication Adherence

Genetic Testing and Motivational Counseling for FH

GENMOTIV-FH
Start date: June 15, 2020
Phase: N/A
Study type: Interventional

To date, there are highly effective lipid-lowering drugs, the combination of which makes it possible to achieve the target level of LDL-C in most patients with familial hypercholesterolemia (FH). However, the effectiveness of treatment of FH patients strongly depends on adherence to lipid-lowering therapy and to the healthy lifestyle, as well as the detection of the disease and the therapy prescription as early as possible, better in childhood. The aim of the study is to assess the impact of genetic testing and motivational counseling on the effectiveness of treatment and cascade screening in patients with FH.

NCT ID: NCT04526457 Completed - Clinical trials for Hypercholesterolemia, Familial

Is Family Screening Improved by Genetic Testing of Familial Hypercholesterolemia

IFIGhTFH
Start date: November 1, 2014
Phase: N/A
Study type: Interventional

To test the hypothesis that in patients with a clinical diagnosis of familial hypercholesterolemia (FH), genetic testing and identification of a causative mutation might enhance the success of family-based cascade screening.

NCT ID: NCT04313270 Recruiting - Clinical trials for Hypercholesterolemia, Familial

Subclinical Atherosclerosis in Patients With Familial Hypercholesterolemia Treated With Evolocumab®

Start date: December 1, 2017
Phase:
Study type: Observational

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®.

NCT ID: NCT04118348 Completed - Clinical trials for Hypercholesterolemia

Evaluating the Efficacy of Pediatric Lipid Screening Alerts

Start date: October 10, 2019
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate prospectively the impact of different system alerts on the prescription of lipid panels to pediatric Geisinger patients (9-11 years old), as per the now-universal guidelines. This will help quantify the relative effectiveness of different alerts and combinations of alerts on provider prescribing behavior and patient uptake of screening.

NCT ID: NCT04073797 Recruiting - Atherosclerosis Clinical Trials

PET Imaging of Inflammation and Lipid Lowering Study

PIILL
Start date: March 20, 2023
Phase: N/A
Study type: Interventional

While 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) imaging has been used as an early marker of drug efficacy in numerous clinical cardiovascular drug trials, as a glucose analog, its signal in the vasculature lacks inflammatory cell-specificity. Moreover, high background 18F-FDG signals from the myocardium often preclude coronary artery imaging, despite attempts to suppress myocardial tracer uptake by dietary manipulation. These limitations of 18F-FDG for measuring changes in vascular inflammation arising from drug intervention highlight important unmet needs, which might be overcome by using a somatostatin receptor subtype-2 (SST2) PET tracer.

NCT ID: NCT03989167 Recruiting - Clinical trials for Hypercholesterolemia, Familial

Clinical Decision Support for Familial Hypercholesterolemia

CDS-FH
Start date: December 6, 2022
Phase: N/A
Study type: Interventional

A cluster randomized study in the primary care setting to evaluate a computer-based clinical decision support system to aid in the identification and management of patients with FH. The primary outcome of the study is the number of patients diagnosed with FH at thirty months after study initiation.

NCT ID: NCT03795038 Completed - Clinical trials for Cardiovascular Diseases

Comparison of the Plasma Lipoprotein Apheresis Systems DIAMED and MONET vs. the Whole Blood Apheresis System DALI

DIAMOND-2018
Start date: December 28, 2018
Phase: N/A
Study type: Interventional

The clinical Investigation will be performed to compare the safety and effectiveness of the CE certified and established lipoprotein apheresis systems MONET vs. DALI and DIAMED vs. DALI for optimizing the individual therapy of patients with severe dyslipidemia using established and novel efficacy parameters.