Clinical Research Directory

Causes and Natural History of Dyslipidemias

This study will evaluate people with dyslipidemias - disorders that affect the fat content in the blood. Fats, or lipids, such as cholesterol and triglycerides, are carried in the blood in particles called lipoproteins. These particles are involved in causing blood vessel diseases that can lead to conditions like atherosclerosis (hardening of the arteries) or heart attack. Participants will undergo accepted medical tests and procedures to evaluate their condition. Most of the test results are helpful in making a diagnosis and in guiding treatment. People with lipid disorders are eligible for this study. Representative types of patients include those with: * Plasma cholesterol levels greater than 200 mg/dl or less than 120 mg/dl * Plasma LDL-C levels greater than 130 mg/dl or less than 70 mg/dl * Plasma HDL-C levels greater than 70 mg/dl or less than 25 mg/dl * Unusual cholesterol deposits or xanthomas (nodules of lipid deposits on the skin) Children under 2 years of age are excluded from the study. Participants will undergo some or all of the following procedures: \- Plasma evaluation. Apolipoproteins (plasma proteins involved in metabolism of cholesterol, triglycerides, phospholipids, and proteins in the blood) and enzymes involved in lipid metabolism are measured....

To Evaluate the Safety and Pharmacokinetic Characteristics of AJU-C716 and C716R in Healthy Adults

To Evaluate the Safety and Pharmacokinetic Characteristics of AJU-C716 and C716R in Healthy Adults

Assessing Outcomes of Enhanced Chronic Disease Care Through Patient Education and a Value-based Formulary Study

The purpose of this study is to determine the effect of two novel interventions; (1) a value-based formulary which eliminates copayment for selected high-value medications (proven to prevent heart attacks, stroke, and hospitalizations); and (2) a comprehensive patient education program aimed at lifestyle modification and optimal drug use, combined with relay of information on medication use, on the risk of adverse clinical outcomes (mortality, heart attack, stroke, need for coronary revascularization, and chronic disease related hospitalizations) in low-income seniors with chronic conditions over three years of follow-up or until March 31, 2021 (whichever comes first).

A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia

This study is researching an experimental drug called alirocumab, referred to as "study drug". In the United States, alirocumab is approved for the treatment of hypercholesterolemia (high blood cholesterol levels). The aim of the study is to see how safe and effective alirocumab is when given weekly to adult participants who have hypercholesterolemia. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug once a week * How much study drug is in the blood at different times

Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels

The goal of this clinical trial is to find out if lipodia, a digital health intervention, can help lower cholesterol levels and improve other health measures in adults with high cholesterol. The main questions it aims to answer are: * Does lipodia, together with regular treatment, lower LDL cholesterol (bad cholesterol) better than regular treatment alone? * Does lipodia help improve other health outcomes, like how confident participants feel in managing their health? Researchers will compare two groups: * Intervention group: Participants use the lipodia intervention and continue their usual treatment. * Control group: Participants continue with their usual treatment only. Participants will: * Fill out questionnaires online and visit a certified lab at the start of the study, after 3 months, and after 6 months * Have blood tests at each lab visit to check their cholesterol and other blood fat levels * Continue with their usual treatment (both groups) and use lipodia, a digital health app, for six months (intervention group only)

A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of AG2304T and AG2304R

A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of AG2304T and AG2304R in Patients with Primary Hypercholesterolemia

Moderate-Intensity Statin Plus Ezetimibe in CKD and ASCVD

The ULTRA-CKD trial is a prospective, randomized, open-label, multicenter trial designed to compare the efficacy and safety of moderate-intensity statin plus ezetimibe combination therapy versus high-intensity statin monotherapy in patients with chronic kidney disease (CKD) and concomitant atherosclerotic cardiovascular disease (ASCVD). Patients with CKD are at very high risk for ASCVD. In this population, it is important to establish a lipid-lowering strategy that optimizes cardiovascular outcomes while ensuring long-term safety. While high-intensity statins are generally considered as initial treatment option for secondary prevention, the optimal strategy for CKD patients remains to be clinicaly defined. This study aims to evaluate whether the combination of moderate-intensity statin and ezetimibe is non-inferior to high-intensity statin monotherapy in terms of 3-year composite of major adverse cardiovascular events.

A Study Of SHR-1918 In Participants With Hypercholesterolemia With Inadequate Lipid Control on Statins Plus PCSK9 Inhibitors

The purpose of the study is to evaluate the efficacy and safety of SHR-1918 in patients with hypercholesterolemia with inadequate lipid control on statins plus PCSK9 inhibitors. The efficacy and safety of SHR-1918 will be evaluated after 12-weeks and 24-weeks treatment.

Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Secondary Prevention

This study will evaluate the effectiveness and safety of combining two different types of PCSK9 inhibitors, inclisiran and alirocumab, in patients with high cardiovascular risk who are unable to tolerate statins. Lowering low-density lipoprotein cholesterol (LDL-C) is essential to reduce the risk of cardiovascular events. While PCSK9 inhibitors are effective, many patients treated with a single agent do not reach recommended LDL-C targets, especially those who cannot take statins. Inclisiran and alirocumab reduce LDL-C through different mechanisms. Inclisiran decreases the production of PCSK9 in the liver, while alirocumab binds circulating PCSK9 in the blood. Combining these therapies may lead to a greater reduction in LDL-C levels. In this randomized, open-label clinical trial, approximately 60 patients in secondary prevention will be assigned to one of three groups: inclisiran alone, alirocumab alone, or a combination of both treatments. Patients will be followed for 9 months with regular clinical and laboratory assessments. The main goal of the study is to determine whether combination therapy leads to greater LDL-C reduction compared to each treatment alone. Secondary objectives include assessing the proportion of patients achieving target LDL-C levels and evaluating treatment safety and tolerability.

Church-based Health Intervention to Eliminate Racial Inequalities in Cardiovascular Health

Cardiovascular disease (CVD) is the leading cause of death in the US general population. Although CVD mortality rates declined for both Black and White populations during the past two decades, they are still higher in Black adults than White adults. There are also persistent disparities in CVD risk factors with higher prevalence of obesity, hypertension, and diabetes in Black compared to White populations. In addition, CVD and risk factors are more prevalent in the residents of Louisiana compared to the US general population. The Church-based Health Intervention to Eliminate Racial Inequalities in Cardiovascular Health (CHERISH) study will use a church-based community health worker (CHW)-led multifaceted intervention to address racial inequities in CVD risk factors in predominantly Black communities in New Orleans, Louisiana. The primary aim of the CHERISH study is to compare the impact of two implementation strategies - a CHW-led multifaceted strategy and a group-based education strategy - for delivering interventions recommended by the 2019 American College of Cardiology (ACC)/American Heart Association (AHA) Guideline on the Primary Prevention of Cardiovascular Disease on implementation and clinical effectiveness outcomes in predominantly Black church community members over 18 months.

Lipoprotein Metabolism in Normal Volunteers and Patients With High Levels of Lipoproteins

Researchers plan to study the fat-rich particles, called lipoproteins, which circulate in the blood. This study is designed to improve understanding of normal, as well as abnormal, lipoprotein metabolism and the role it plays in the development of hardening of the arteries (atherosclerosis). Patients participating in this study will receive injections of lipoproteins or apolipoproteins (the protein component of lipoproteins) that have been isolated and purified. These lipoproteins will be labeled with small amounts of radioactive material and sterilized before they are injected into the patient. Patients participating in the study will be required to have blood samples taken, and provide urine samples throughout the course of the study. In addition, patient will be required to follow a specially formulated diet. Patients will be weighed throughout the course of the study.

A Tool to Help Patients With Muscle Symptoms After Taking a Statin Medication.

The goal of this clinical trial is to learn if an educational website can help patients make an informed decision and engage in shared decision-making with their healthcare provider regarding cholesterol lowering medication use after they have stopped statin therapy due to self-reported muscle symptoms from taking a statin medication. The main questions the trial aims to answer are: 1. Compared to usual care, are patients who engage with the website after experiencing statin-associated muscle symptoms (SAMS) more likely to retry statin therapy? 2. Compared to usual care, are patients who retry statin therapy after engaging with the website more likely to persist on statin therapy? Researchers will compare people randomized to use the website to those who are receiving usual care to see if statin re-start and persistence rates change. All participants will take baseline questionnaires and receive usual care as they would if they were not in the study (e.g., visit their doctor, get labs drawn, take medication as prescribed). Patients randomized to the website arm will be asked to engage with content in a website which is anticipated to take most patients approximately 30-minutes. Their clinician will then contact them for a follow-up visit as needed.

Improving Lipid Optimization Quality and Treatment Options in ASCVD

The goal of this project is to study different approaches to improve the utilization of guideline directed medicines to lower cholesterol in patients with or at high risk of atherosclerosis (cholesterol buildup in the arteries).

WB-EMS Effects on Cardiometabolic Risk Factors

From the age of 50 onwards, there is a disproportionate decline in muscle strength, mass and function, which can be prevented or at least delayed by physical training. Unfortunately, many training programmes are very time-consuming and strenuous and are therefore not carried out consistently. Whole-body electromyostimulation (WB-EMS), a technology in which all major muscle groups are stimulated with an adjusted stimulation level, could be a time-effective and joint-friendly alternative. However, there are some contraindications to the widespread use of this technology, which are particularly common in middle-aged and elderly people. For example, high blood pressure, which affects more than half of men over the age of 50 in Germany, is considered a contraindication for WB-EMS training. However, this assessment is not very reliable; at least, acute WB-EMS application does not lead to an increase in blood pressure. In addition, there are no study results available for long-term WB-EMS application in people with high blood pressure. The present study particularly investigate whether and to what extent several weeks of WB-EMS training has an effect on resting blood pressure in people with mild blood pressure. Additionally, the effect of WB-EMS on other cardiometabolic risk factors and physical function will be addressed.

Study on the Effect of the Intake of a Calcium-bicarbonate Water on Cholesterol Levels

The goal of this study is to evaluate the hypolipidemic effect (reduction of Low Density Lipoprotein Cholesterol "LDL-C" values) of calcium-bicarbonate mineral water "Lete" (alkaline water, high in bicarbonate and calcium ions and low in sodium) compared to control oligomineral water "Sorgesana" on healthy volunteers

Efficacy and Safety of Ezetimibe/Rosuvastatin and Amlodipine Patients With High Blood Pressure and High Cholesterol

The goal of this clinical trial is to test whether one pill that combines ezetimibe, rosuvastatin, and amlodipine can safely lower cholesterol and blood pressure in Korean adults with high blood pressure and high cholesterol.

Vascular Intervention Strategies Trial for Alzheimer's

The proposed pharmacist-led study is a feasibility pilot trial for the management of vascular risk factors of hypertension and hypercholesterolemia in 10 APOE ε4 carriers, 50-75, at-risk for dementia. All participants will receive angiotensin receptor blockers (ARBs) for high blood pressure, and hydrophilic statins (or a non-statin alternative) for high cholesterol over a six-month period.

Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia

VT-20101 is an Open-label, Phase 1b, Single-ascending dose study that will evaluate the safety of VERVE-201 administered to patients with Refractory Hyperlipidemia. VERVE-201 uses base-editing technology designed to inactivate the expression of the ANGPTL3 gene in the liver and lower circulating low-density lipoprotein cholesterol (LDL-C) and triglycerides. This study is designed to determine the safety and pharmacodynamic profile of VERVE-201 in this patient population.

Assessing the Effects of Corn and Avocado Oils on the Cardiometabolic Risk Factor Profile

The goal of this clinical trial is to assess the effects of corn and avocado oils as part of controlled feeding diets on the cardiometabolic risk factor profile in men and women with mild-to-moderately elevated levels of non-high-density lipoprotein cholesterol (non-HDL-C). Participants will be asked to consume the controlled feeding diet for two separate 21 day conditions, and will consume their regular diet for a 21 day washout period between the two conditions. Additionally, participants will be asked to come into the clinic on 7 different occasions, including one screening visit (visit 1, -7 days), one baseline visit (visit 2, day 0), two visits during each 21-d diet condition (visits 3 \& 6, day 19 and visits 4 \& 7, day 21), and a visit at the conclusion of the washout phase/start of the second diet condition (visit 5, day 0).

Study of Efficacy, Safety, Tolerability and Quality of Life of Inclisiran (KJX839) vs Placebo, on Top of Ongoing Individually Optimized Lipid-lowering Therapy, in Participants With Hypercholesterolemia

Study of efficacy, safety, tolerability and quality of life of inclisiran (KJX839) vs placebo, on top of ongoing individually optimized lipid-lowering therapy, in participants with hypercholesterolemia

Pharmacogenomic Informed Statin Prescribing

Statins are the most cost-effective medications to lower cholesterol and cardiovascular disease (CVD) risk. However, many patients at high-risk for CVD do not accept or adhere to statins. This gap in patient's use of statins limits the full impact of these effective medications resulting in higher cholesterol levels and CVD risk. The main barriers to using statins are patients' perceived lack of benefit, excess risk of statin toxicity as well as their misperceptions of their CVD risk. Statin pharmacogenomic testing - an application of precision medicine - is a readily available, feasible, and inexpensive intervention that addresses this barrier by using genetic testing to identify the nearly 1 out of 2 patients with enhanced benefit and/or reduced risk of statin toxicity or increased risk for CVD. By communicating statin pharmacogenomic test results to Veterans at high-risk for CVD not taking statin therapy, the investigators aim to improve patients' perceptions of their risk of CVD and statins and, in turn, their acceptance of and adherence to statins to reduce their cholesterol levels and CVD risk.

Dachundou No Sugar Added Soymilk for Lipid Modulation

Cardiovascular disease is one of the leading causes of death worldwide, and high cholesterol is a major risk factor. Diet is known to play an important role in managing blood lipids. Soy milk is a common plant-based drink rich in protein and isoflavones, which may help lower cholesterol and improve heart health. This clinical trial will evaluate whether daily consumption of Dachundou No Sugar Added Soymilk can help reduce cholesterol levels in adults with elevated total cholesterol (≥200 mg/dL). A total of 50 participants aged 18-65 will be recruited. Participants will drink two bottles of soymilk per day (375 mL each, total 750 mL) for 8 weeks. During the study, researchers will measure cholesterol, blood pressure, body weight, waist circumference, and other health indicators. The results will help determine whether Dachundou No Sugar Added Soymilk can improve blood lipid levels and contribute to cardiovascular health.

Triple vs Dual Lipid-Lowering Therapy for LDL-C Reduction in Acute Coronary Syndrome

The goal of this clinical trial is to evaluate whether triple lipid-lowering therapy (atorvastatin, ezetimibe, and bempedoic acid) is more effective than dual therapy (atorvastatin and ezetimibe) in reducing LDL cholesterol levels in adults with acute coronary syndrome. It will also assess the safety of the treatment. The main questions it aims to answer are: * Does triple therapy result in greater reduction in LDL-C compared to dual therapy? * What adverse effects occur in participants receiving triple therapy? Researchers will compare triple therapy to dual therapy to determine its effectiveness in lowering LDL-C levels. Participants will: * Receive either dual or triple lipid-lowering therapy for 3 months * Attend regular follow-up visits for clinical assessment and laboratory testing * Undergo lipid profile evaluation at baseline and at the end of the study

Long-term Follow-up of Participants Dosed With an Investigational Gene Editing Therapy for Cardiovascular Disease

LTF-001 is a long-term follow-up study of participants who received an investigational gene-editing therapy developed by the sponsor to evaluate the long-term effects of the investigational therapy. Participants will be followed for a total of 15 years after the first administration of the gene-editing therapy.