Active clinical trials for "Hypercholesterolemia"

True prevalence of FH in the Russian Federation is unknown which leads to low percentage of diagnosed and treated cases. Research is needed to determine the prevalence of FH, specific diagnostic algorithms and optimal treatment strategies. The main aim of the present study is to evaluate the extent to which FH is underdiagnosed and undertreated in the Russian Federation for reduction of cardiovascular risk related to atherosclerosis in the country. As a first step, total cholesterol (TC) and low-density lipoprotein (LDL-C) levels will be determined in a random sample from Moscow population (n=18000). It is expected that TC ≥ 7.5 mmol/L will be detected in 10% of cohort. During 2014, approximately 500 patients will pass through non-invasive clinical examination at the Russian Cardiology Research and Production Center, including patient demographics, past medical history, family history of hypercholesterolemia, physical findings, current lipid-lowering therapies, blood tests, genetic analysis, echocardiography, carotid duplex ultrasound and exercise SPECT imaging in selected cases. On the basis of the Moscow Program four major Federal Medical Centers will be involved, and FH Registry will be created as a national, multi-center initiative to screen FH patients, control their diagnosis and management, and track clinical-reported outcomes over time. Establishment of National Guidelines for the diagnosis and treatment of FH on the basis of these data and implementation those into clinical practice in different regions of Russia will allow improving patient care. As an expected outcome, this program will raise awareness and increase appropriate assessment and treatment of FH patients in Russia, leading to a timely detection of the disease and therapy initiation.

In a randomized controlled trial we will research the effect of calorie restriction with early and mid-day time-restricted eating (TRE) and daily calorie restriction on weight loss and human health parameters. Participants will be divided into three groups: early time-restriction group (8:00 AM to 4:00 PM), mid-day restriction group (1:00 PM to 9:00 PM) and daily calorie restriction group (8:00 AM to 9:00 PM). Participants will follow dietary strategy with three planned meals and calorie restriction. Anthropometrical and biochemical parameters will be measured at baseline, after one month, two months and at after three months of intervention. Resting metabolic rate, ultrasound scan of abdomen and ultrasound scan of carotid arteries will be measured at baseline and after three months of intervention. In addition, stool samples will be also taken at baseline and after three months of intervention.

JS002 is a recombinant humanized anti-PCSK9 monoclonal antibody. This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, PK/PD profile, immunogenicity as well as complete delivery of auto-injector by patients of JS002 as monotherapy in patients with primary hypercholesterolaemia and mixed dyslipidemia. In this study, two dose cohorts(150 mg, 450 mg) are set up, and 582 subjects are planned to be enrolled (randomizedly assigned to JS002 or placebo 150/450 mg group in a 2:1:2:1 ratio).A screening period (≤6 weeks), a double-blind treatment period (12 weeks), an open-label treatment period (40 weeks), and a follow-up period (8 weeks) will be required.

This is a multicenter, non-randomized, non-interventional three-cohort study with prospective collection of primary data of treatment with newly initiated oral Lipid lowering treatment on top of a statin (Oral LLT cohort), newly initiated Inclisiran (Inclisiran cohort) and newly initiated Inclisiran on top of lipid apheresis (Apheresis plus Inclisiran cohort) in routine clinical care. All procedures, treatment adaptions and laboratory assessments are part of clinicla routine and conducted independent of this study.

Chitosan is a natural polysaccharide of β-1,4-linked glucosamine residues deriving from chitin, a dietary fiber primarily obtained from fungal cell walls and the exoskeletons of various crustaceans (e.g. crab, lobster, and shrimp) and whose cholesterol-lowering properties are due to the hydrophobic bonds it forms with cholesterol and other sterols, interfering with the emulsification process in the intestine. In addition to reducing low-density lipoprotein cholesterol (LDL-C) levels, several studies showed that chitosan administration may help reduce body weight. For this reason, its use might be particularly useful as a strategy to simultaneously control two different risk factors for the development of CVDs.

SAFEHEART is a large, on-going registry study in molecularly defined patients with heterozygous FH treated in Spain.

mRNA therapy is a highly promising gene therapeutic strategy in the treatment of Homozygous Familial Hypercholesterolemia (HoFH). Exosomes is safe and efficient carriers for mRNA drug delivery, due to their biocompatibility, bioavailability. This first-in-human study is aimed to evaluate the safety and preliminary effectiveness of Exosome-based ldlr mRNA nanoplatform for gene therapy in HoFH.

The project is a national, prospective, multicenter, non-interventional pilot project of screening for the disease Familial hypercholesterolaemia (FH) in newborns in the Czech Republic. The main goal of the project is to methodically prepare, implement and evaluate a pilot project that will verify the suitability of the proposed procedure of early detection of Familial hypercholesterolaemia in such a way as to ensure the maximum positive impact on the health of the population and high cost-effectiveness of the whole process.

Mexico is going through a major environmental and nutritional crisis, which is related to unsustainable dietary behaviors. Sustainable diets could solve both problems together. However, in Mexico and the world, an intervention program oriented to promoting sustainable diets has not been designed. This study protocol aims to design a 3-stages, 15 weeks, sustainable-psycho-nutritional digital intervention program whose objective is to promote the adherence of the Mexican population to a sustainable diet and to evaluate its effects on dietary water and carbon footprints, metabolic biomarkers, and gut microbiota of this population. The behavior change wheel model and the guide for digital interventions design will be followed. In stage 1, the program will be designed using the sustainable diets model, and the behavior change wheel model. A sustainable food guide, sustainable recipes, and food plans as well as a mobile application will be developed. In stage 2, the intervention will be carried out for 7 weeks, and a follow-up period of 7 weeks, in a sample of Mexican young adults (18 to 35 years) randomly divided into an experimental group (n=50) and a control group (n=50). The nutritional care process model will be used. Anthropometric, biochemical, clinical, dietary, environmental, socioeconomic level and cultural aspects, nutritional-sustainable knowledge, behavioral aspects, and physical activity will be considered. Thirteen behavioral objectives will be included using successive approaches in online workshops twice a week. The population will be monitored using the mobile application that will include behavioral change techniques. In stage 3, the effects of the intervention will be assessed on the dietary water and carbon footprint, lipid profile, serum glucose, and gut microbiota composition of the evaluated population. It is expected to find improvements in health outcomes and a decrease in dietary water and carbon footprints. With this study, the first theoretical-methodological approach to the sustainable-psycho-nutrition approach will be generated.

This observational matched prospective study aims to assess the effectiveness and adherence for inclisiran in combination with Lipid lowering therapies or Lipid lowering treatments (LLT) compared to other LLTs under conditions of routine clinical practice.