Clinical Research Directory

Effect of Compound (Cardiol Forte) on Lipid And Glycemic Parameters in Low Cardiovascular Risk Individuals

This study will evaluate the effects of a combination dietary supplement, Cardiol Forte, on lipid and glycemic parameters in adults at low cardiovascular risk with suboptimal cholesterol levels. After a 14- to 28-day run-in period with standardized dietary and behavioral instructions, 50 participants will be randomized in a 1:1 ratio to receive either Cardiol Forte or matching placebo for 8 weeks under double-blind conditions. After completion of the double-blind phase, all participants will receive Cardiol Forte for an additional 8 weeks in an open-label extension. The primary objective is to compare the change in non-high-density lipoprotein cholesterol (non-HDL-C) from baseline to Week 8 between Cardiol Forte and placebo. Secondary objectives include evaluation of other lipid parameters, fasting plasma glucose, selected inflammatory and liver-related markers, and endothelial reactivity.

Efficacy and Safety of Baroezet Tablet in Korean Patients With Dyslipidemia: A Prospective Observational Study

This study is a prospective, non-interventional, multi-center observational study to evaluate the efficacy and safety of Baroezet Tablet 1/10 mg in Korean patients with dyslipidemia in real-world clinical practice. Patients who are prescribed Baroezet Tablet according to the physician's clinical judgment will be followed for approximately 24 weeks. The study will assess changes in lipid profiles, including LDL-C, as well as safety outcomes such as adverse events.

Validation of Remote Photoplethysmography (rPPG)-Derived Cardiovascular Parameters Against Standard Clinical Measurements and Risk Scores in a Community

The goal of this observational study is to evaluate whether a contactless camera-based technology, called remote photoplethysmography (rPPG), can accurately measure cardiovascular parameters and estimate cardiovascular risk in adults aged 30 years and older living in a community setting in Semanan, Jakarta. This study aims to determine if rPPG can be used as a simple and accessible tool for early cardiovascular screening. The main questions it aims to answer are: 1. Do cardiovascular parameters measured using rPPG (such as blood pressure, heart rate, and cardiac workload) agree with standard clinical measurements? 2. Do cardiovascular risk estimates generated by rPPG (such as ASCVD risk and Framingham heart age) correspond to risk calculations obtained using conventional clinical and laboratory methods? Researchers will compare results obtained from rPPG-based facial video scans with results from standard medical assessments, including blood pressure measurements, heart rate evaluation, and laboratory tests for cholesterol levels, to determine the level of agreement and accuracy. Participants will: 1. Undergo a short facial video scan (approximately 30-60 seconds) using an rPPG-based system 2. Receive standard clinical assessments, including blood pressure and heart rate measurements 3. Provide basic health information (such as age, sex, smoking status, and treatment history) Undergo simple laboratory testing for cholesterol levels This study is expected to help determine whether rPPG can be used as a reliable, non-invasive, and scalable screening tool for cardiovascular risk in community and primary healthcare settings.

Implementation Facilitation of Exercise is Medicine Greenville

A public health priority exists for the U.S. healthcare sector to integrate physical activity (PA) as a part of the patient care model. This research will provide valuable information on facilitating optimal implementation of a clinic-to-community model that identifies, refers, and enrolls physically inactive patients to community-based PA programs for the prevention and treatment of chronic diseases. Further, this work will provide evidence on the cost-effectiveness of integrating PA in healthcare systems as a population health management strategy.

A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4954 in Healthy Adult Participants With or Without Elevated Lipoprotein (a) (Lp[a]) Levels, and Participants With Dyslipidemia

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of AZD4954 in healthy participants with or without elevated Lipoprotein(a) (Lp\[a\]) levels and participants with dyslipidemia.

Natural History of Uncommon Dyslipidemias, Rare Lipid Disorders and Unusual Atherosclerotic Conditions

Background: The right amount of fats in the blood (cholesterol and triglycerides) are a key part of a healthy organism. Too much or too little of these fats may manifest as diseases (dyslipidemia). There are many causes for these abnormalities, but some are genetically determined and we would like to better understand the progression of these conditions over time. Objective: This natural history study aims to learn more about dyslipidemias; how they change over time; and how they respond to therapy. We also want to develop new diagnosis methods for these conditions. With the knowledge we will acquire we hope to provide new insights, new approaches and improve the overall health of these patients. Eligibility: Individuals aged 10 years and older, residing both within and outside the United States, who have or are suspected of having a disorder that causes changes in the levels of fats in their blood (genetic dyslipidemias). Design: Participants residing within and outside the United States will be screened. Their medical records may be reviewed. They may talk to researchers about their medical history by phone, telehealth, or in person. All study visits are optional. Participants may visit the NIH up to 15 times per year, if needed. Each visit may include a physical exam and blood tests. Participants may also have an electrocardiogram (EKG). The EKG measures the electrical activity when the heart beats. In some cases, participants may remain in the study for up to 20 years.

The Non-high-density Lipoprotein Cholesterol (Non-HDL-C) to High-density Lipoprotein Cholesterol (HDL-C) Ratio (NHHR) and Its Association With Occurrence of Diabetic Nephropathy in Patients With Diabetes Mellitus

The study aims to examine the relationship between the non-high-density lipoprotein cholesterol-to-high-density lipoprotein cholesterol ratio (NHHR) and CKD in patients with DM.

Effect of a Low-Calorie MCT-Rich Traditional Minangkabau Diet on Obese Individuals

This study aims to investigate the effect of a low-calorie diet rich in medium-chain triglycerides (MCTs) based on traditional Minangkabau foods on metabolic biomarkers in individuals with obesity. The traditional Minangkabau foods used in this study consist primarily of coconut milk-based dishes, which contain coconut oil as a natural source of MCTs. The metabolic biomarkers assessed include body mass index (BMI), waist circumference, systolic and diastolic blood pressure, body fat percentage, fasting blood glucose levels, lipid profile, leptin concentrations, and DNA methylation of the leptin gene promoter. Based on these metabolic biomarker measurements, participants will be classified into metabolic obesity phenotypes, namely metabolically healthy obesity (MHO) and metabolically unhealthy obesity (MUHO). The researchers hypothesize that the provision of a low-calorie, MCT-rich diet based on traditional Minangkabau foods will have a significant effect on metabolic biomarkers and metabolic status in individuals with obesity.

Clinical Management of Cardiovascular Risk Factors in Adult Patients: A Before-and-After Interventional Study

This study aims to evaluate cardiovascular risk factors, clinical characteristics, and outcomes in adult patients attending an outpatient cardiology clinic. The research focuses on identifying predictors of adverse cardiovascular events, optimizing risk stratification, and improving preventive strategies in routine clinical practice. Data will be collected from patients receiving standard cardiology care without altering their treatment. The results are expected to contribute to better understanding of cardiovascular risk profiles and to support improvements in clinical decision-making and patient management.

Digital Care for Holistic Health in Older Adults With Diabetes and Multimorbidity

The purpose of this study was to explore the effectiveness of the "Digital Care Community Common Good" program in improving disease control indicators, self-management abilities, depression, and quality of life among patients with comorbidities and type 2 diabetes. The study was designed as a two-year experimental study, with a specific area in New Taipei City selected as the research site. In the first year, the main tasks include establishing an integrated intervention team composed of primary healthcare providers and community resources, expanding the functionalities of the mHealth platform, developing digital educational materials for diabetes comorbidities care, and recruiting and training 6 to 8 community care volunteers. Additionally, 169 eligible participants with type 2 diabetes and comorbidities will be recruited from four communities, completing baseline assessments and randomization into groups. In the second year, a 6-month intervention and effectiveness evaluation of the " Digital Care Community Common Good " program will be implemented. The intervention includes online and in-person educational sessions, telephone care, use of the mHealth platform (featuring educational, data monitoring, contextual learning, interactive, and reminders), as well as home visits, case discussions, and individualized care plans for high-risk cases. Disease control indicators, selfmanagement abilities, depression, and quality of life will be tracked immediately post-intervention, at 3 month, and at 6 month to assess outcomes and changes over time. This study expects to enhance health management for diabetes patients with comorbidities through digital care and interdisciplinary collaboration, offering evidence-based insights and recommendations for policy implementation in the integration of community and primary healthcare models.

Guideline Adherence in Dyslipidemia With Clinical Decision Support

Objective: To validate the performance of the developed clinical decision support system (CDSS) for participants with lipid metabolism disorders based on a decision tree algorithm. Materials and Methods: A clinical decision support system for participants with lipid profile abnormalities will be developed using the Orbeon open-source online form creation platform based on current clinical guidelines. During the CDSS pilot implementation, the electronic medical records (EMRs) of 500 participants from the Institute of Personalized Cardiology of the Biomedical Science and Technology Park at Sechenov University will be analyzed. Retrospective data on prescribed lipid-lowering therapy extracted from the EHR will be compared with the CDSS recommendations. The accuracy of the decisions will be assessed by three independent experts based on digitized clinical and laboratory patient profiles. The primary endpoint of the study will be to determine the accuracy of the system. Results: This study will result in the development (creation) and pilot application of the CDSS program in participants with dyslipidemia in real clinical practice. Conclusion: The developed CDSS system for dyslipidemia will significantly reduce the time required for clinical decision-making and help avoid errors in the interpretation of patient data.

Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients With Homozygous Familial Hypercholesterolemia

This observational, multicenter, retrospective and prospective study aims to evaluate the effect of lomitapide treatment on Major Adverse Cardiovascular Events (MACE) in patients with Homozygous Familial Hypercholesterolemia (HoFH). HoFH is a rare genetic disorder characterized by extremely high levels of LDL cholesterol (LDL-C), leading to an increased risk of early cardiovascular diseases. Lomitapide is an approved medication that lowers LDL-C levels by inhibiting microsomal triglyceride transfer protein (MTP). The study will collect data from patients who have been treated with lomitapide for at least 12 months and will compare the incidence of MACE during the first three years of treatment with the three years before treatment initiation. The study includes data collection from multiple lipid centers across Europe. The primary objective is to assess the impact of lomitapide on MACE, while secondary objectives include evaluating changes in lipid profiles, liver function tests, and lipid-lowering treatments.

The Effects of Rosuvastatin on Running Training Adaptation and Safety

Statins lower low-density lipoprotein cholesterol (LDL-C) and help prevent atherosclerotic cardiovascular disease, but some users develop statin-associated muscle symptoms (SAMS) such as soreness, stiffness, weakness, or elevated creatine kinase (CK). These symptoms may be more noticeable during exercise. Regular long-distance running improves cardiopulmonary fitness-VO₂max, aerobic threshold (AT), and respiratory compensation point (RCP)-mainly through mitochondrial and metabolic adaptations. Prior studies suggest that lipophilic statins like simvastatin may blunt these adaptations, while hydrophilic statins such as rosuvastatin may have a smaller impact. However, prospective data in habitual endurance runners are limited. This randomized controlled trial will examine how rosuvastatin affects cardiopulmonary fitness improvements and muscle tolerance in individuals who run at least three times per week and meet clinical criteria for statin therapy. After informed consent and baseline cardiopulmonary exercise testing (CPET), participants will be randomized to rosuvastatin 10 mg daily or no statin therapy for three months. Both groups will maintain their usual training routines, and training load will be recorded using heart-rate-based TRIMP. CPET will be repeated monthly to assess changes in VO₂max, AT, and RCP, and muscle enzymes and SAMS will be evaluated at each visit. The study aims to clarify whether rosuvastatin influences endurance-related physiological adaptations or increases muscle symptoms in regular long-distance runners.

To Test the Effectiveness and Implementation Approach of a 3-month PILI Pasifika Program Lifestyle Program With Components of Social Determinants of Health Activities in Real-world Settings (Clinical and Non-clinical Settings) Across 3 Years

In this study, the investigators are testing the effectiveness and implementation of the Community Health Workers (CHW)-delivered PILI Pasifika Program (PPP) Standard Facilitation or Enhanced Facilitation across 3 regions, the U.S. Affiliated Pacific Islands (USAPI), the continental U.S., and Hawai'i, among 600 Native Hawaiian and Pacific Islander (NHPI) participants in two settings, (clinical and non-clinical) over a 3-year period. The PPP is a 3-month lifestyle intervention that includes a Social Determinants of Health (SDOH) component and was NHPI-adapted from the Diabetes Prevention Program's Lifestyle Program, renamed to the PILI Lifestyle Program (PLP), which demonstrated effectiveness in improving weight, blood pressure, physical activity, and diet among NHPIs. The PPP consists of 8 lifestyle lessons and 4 SDOH activities delivered over a 3-month period. The investigators will conduct an effectiveness-implementation hybrid type 2 trial using a 3 (Region) x 2 (Setting) x 2 (Delivery Mode) factorial design. The long-term objective of this study is threefold: 1. To conduct an effectiveness-implementation hybrid 2 trial to test the effects of the PPP implementation strategies across different settings and modes of delivery among 600 NHPIs at risk for cardiometabolic-related conditions using an NHPI-approved and adapted evaluation framework. The investigators will also assess and compare the cost-effectiveness of the CHW-delivered PPP-Standard Facilitation and PPP-Enhanced Facilitation to support long-term sustainability. 2. To conduct a longitudinal Social Determinants of Health (SDOH) survey embedded within the trial to examine the reliability and validity of indices from 5 adapted SDOH instruments and to assess the associations between SDOH variables and chronic disease risk among NHPIs. 3. To implement and evaluate the contextually-based CHW training program on PPP delivery.

Community Physical Exercise Program in Chronic Disease

This study focuses on promoting physical activity (PA) through the implementation of a Community Physical Exercise Program for Chronic Diseases (CPEP-CD), targeting individuals aged 50 years and older with at least two of the following conditions: cardiovascular and/or cerebrovascular disease or risk (CVD), overweight, diabetes mellitus (DM), and musculoskeletal diseases. The primary objective is to improve muscle and cardiorespiratory health and well-being, while also contributing to a more objective and evidence-based exercise prescription for these pathological conditions. Population ageing is a global challenge associated with an increased prevalence of chronic diseases that compromise quality of life (QoL). A sedentary lifestyle is linked to declines in muscle function and cardiorespiratory fitness and is considered a major risk factor for morbidity and mortality. Consequently, physical exercise is widely recommended as a key non-pharmacological intervention across multiple chronic diseases. According to World Health Organization (WHO) guidelines, regular PA is a protective factor in the prevention and management of non-communicable diseases, including cardiovascular and cerebrovascular diseases and DM. In addition, PA provides mental health benefits, supports healthy weight maintenance, and enhances overall well-being. In adults, regular PA is associated with reductions in all-cause mortality, cardiovascular mortality, and the incidence of hypertension. Within this context, the aim of this project is to implement a community-based physical exercise program for individuals with chronic disease and multimorbidity, focusing on CVD and cerebrovascular disease or risk, DM, and OA. The program integrates existing exercise prescription guidelines while personalizing exercise progression according to both disease-specific and multimorbidity profiles. The primary outcomes include improvements in cardiorespiratory fitness, muscular strength, bone health, functional capacity, and QoL. Additionally, through individualized training monitoring, this study seeks to establish an exercise prescription tailored to the most prevalent combinations of chronic diseases, thereby providing more objective and practical guidance for family physicians, exercise professionals, and rehabilitation specialists, and supporting more personalized and targeted exercise-based strategies for chronic disease prevention and management.

EFFECTS OF A YERBA MATE EXTRACT IN REDUCING METABOLIC SYNDROME IN OVERWEIGHT INDIVIDUALS

Yerba mate (Ilex paraguariensis), a traditional drink consumed in different parts of the word, but especially in southern Brazil, is an importante source of polyphenols and has a high antioxidant potencial, With a moderate content of methylxanthines, yerba mate has stood out for its promising effects in modulating metabolic pathways in pre-clinical models. However, its beneficial effets in clinical trials have yet to be elucidated. Overweight and chronic non-communicable diases are urgent public health conditions and reducing the risk of these conditions through food sources is one of the most sustainable approaches. This study aims to evaluate the impact of a standardized extract of yerba mate on nutritional, biochemical, metabolic, inflammatory and antioxidant status parameters in overweight individuals compared to a placebo. A double-blind, parallel, randomized, placebo- controlled clinical trial will be conducted involving 80 overweight individuals. The subjects will receive an encapsulated yerba mate extract totaling 2,250 mg or a corresponding placebo, fractionated three times a day. This amount was defined according to previous studies thet estimated the habitual intake of yerba mate in the form of chimarrão or tererê by adults in a city in the southern region of the country. Anthropometric measurements, composition, blood pressure and blod and stool samples will be collected for nutritional assessment, metabolic and inflammatory parameters and antioxidant status assessment on days 0 and 90. The data will be analyzed descriptively and inferentially. Differences in the individuals characteristics at baseline and comparisons between groups will be aseessed using the difference of means test (depending on the normality of the data) and chi-square or Fisher-s exact test for categorical variabes, In addition, to compare the effect of the intervention between the groups, a two-way analysis of covariance will be used. A 5% significance level will be adopted. It is expect to find positive effects of yerba mate extract on the parameters assessed.

A Novel Digital Tool Physicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors

The investigators will conduct a feasibility and pilot efficacy randomized controlled trial to test the usability and user satisfaction of an evidence-based digital health tool the investigators developed for physicians to use to Prioritize Personalize Prescribe EXercise (P3-EX) to patients with cardiovascular disease (CVD) risk factors. The investigators will recruit 24 physicians from two local hospitals in CT, USA. Physicians will recruit two patients each (N=48) having CVD risk factors. Physicians will deliver a P3-EX exercise prescription (ExRx) to one of their patients (n=24) and the American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS) ExRx to the other (n=24) in a random sequence crossover design. Physicians and patients will rate the feasibility and acceptability of each method using validated questionnaires. Patients will perform their prescribed ExRx for 12 weeks and complete a self-report exercise diary to monitor exercise adherence with virtual oversight from University of Connecticut (UConn) Graduate Research Assistants. Before and after the exercise intervention, the investigators will measure patient CVD risk factors and physical activity (PA) levels via accelerometry. The primary aim is to evaluate the feasibility and acceptability of P3-EX for physicians to use to prescribe exercise to patients with CVD risk factors, and the secondary aim is to explore the preliminary efficacy of P3-EX to improve patient CVD risk factors, PA levels, and exercise adherence. The investigators hypothesize P3-EX will be feasible for physicians to use to prescribe customized exercise routines for patients with CVD risk factors, and physicians and patients will be satisfied with P3-EX.

Intermittent Cottonseed Oil Consumption

Cardiovascular disease risk factors, including higher BMIs and poor cholesterol profiles, are on the rise and contribute to the United States' growing disease burden. Cottonseed oil (CSO) is found readily in the food supply, and the investigator's previous studies have demonstrated that incorporating CSO into the diet is sufficient to improve fasting and postprandial blood lipids and other markers of chronic disease risk in both healthy and at-risk populations. This study aims to examine the impact of intermittent CSO consumption at different doses (consumed three times per week (3x/wk)) on changes in fasting and postprandial lipid metabolism/blood lipids and markers of chronic disease risk. The specific aims are: \*Examine the impact of intermittent CSO consumption (3x/week) at two different doses on fasting and postprandial lipids. \*Examine the impact of intermittent CSO consumption (3x/week) at two different doses on other markers of chronic disease risk. Participants will be asked to: \*Consume provided meal replacement shakes and snacks 3 times per week for 56 days. \*Attend three bi-weekly (every other week) short visits for fasting blood draws, body measurements, and collection of the next two weeks' study materials. \*Attend two longer (5.5h) testing visits, which include eating a standardized breakfast meal and having blood drawn periodically before and after breakfast. Researchers will compare CSO-30, CSO-20, and Control groups (receiving no oil) to see if intermittent CSO consumption imparts the same health benefits as previously shown with daily doses of CSO.

LLM-CoManage: Large Language Model-Enabled Co-Management of Hypertension, Diabetes, and Dyslipidemia

This study aims to evaluate the effectiveness of a large language model (LLM)-supported, community-based integrated management model in improving cardiometabolic multimorbidity control among adults with hypertension and coexisting diabetes or dyslipidemia. Adopting an interventional study design, eligible patients will be recruited to compare the disease control indicators between LLM-assisted management and conventional management, so as to verify the effectiveness and safety of the former.

Evaluate the Efficacy and Safety of CMG190303 in Patients With Type 2 Diabetes and Dyslipidemia

The goal of this clinical trial is to learn if drug CMG190303 to treat Type 2 Diabetes and Dyslipidemia in adults. It will also learn about the safety of CMG190303. The main questions it aims to answer are: -Primary Objectives: 1. To compare the change in HbA1c from baseline to 24 weeks between CMG190303 and Rosuvastatin 2. To compare the change in LDL-C from baseline to 24 weeks between CMG190303 and Dapagliflozin

Pharmacist Case Finding and Intervention for Vascular Prevention Trial

Heart disease is a common and serious medical condition which causes nearly one in every three deaths worldwide every year. The factors which increase people's risk for heart disease are well-known, but there needs to be more support given to people to reduce their risk of heart disease. Pharmacists are front line primary healthcare providers who see patients more frequently than any other healthcare provider and can help people reduce their risk of heart disease. This research project aims to see whether a pharmacist-led intervention can help people reduce their risk of heart disease. The potential impact of this project is to empower people to understand how to reduce their risk of heart disease and reduce the burden of heart disease on the community.

Yangxin Dawayimixike Honey Paste for Carotid Atherosclerotic Plaque With Dyslipidemia: A Randomized Controlled Clinical Study

This clinical trial aims to evaluate the efficacy and safety of Yangxin Dawayimixike Honey Paste in intervening carotid atherosclerotic plaque combined with dyslipidemia. The study will enroll patients with carotid atherosclerotic plaque and dyslipidemia in a multicenter, randomized, double-blind, placebo-controlled trial. Based on standardized Western medical treatment, the treatment group will receive Yangxin Dawayimixike Honey Paste, while the control group will receive a simulated preparation of Yangxin Dawayimixike Honey Paste. The treatment duration is 12 months, followed by a one-year follow-up period. The primary efficacy endpoint is the change in intima-media thickness (IMT) of the carotid artery. Secondary efficacy endpoints include plaque Crouse score, plaque area, vascular remodeling index (RI), major adverse cardiovascular events (MACE), four lipid parameters (total cholesterol, triglycerides, LDL-C, HDL-C), Traditional Chinese Medicine syndrome score, and quality of life scale (SF-36). Safety indicators include vital signs (respiration, pulse, heart rate, blood pressure), complete blood count, routine urinalysis, routine stool examination, liver and kidney function tests, and four coagulation parameters. These measures will be used to assess the treatment's efficacy and safety.

Lipid Balance in Adult Sickle Cell Patients

This study aims to describe and/or searches for, in cohorts of adult sickle cell anemia (SCA) and SC sickle cell patients living in the French West Indies and followed by SCD Reference and Competence Centers: 1-lipids profiles and associations at steady state with occurrence of sickle cell disease (SCD) complications, 2-lipids profile evolution during and after prospective acute complications (vasoocclusive crises (VOC) and priapism), 3-lipids profile variation (inter /intra individuals) during 4 prospective years, 4- Genetic primary modulators of SCD complications, 5- insulin resistance (HOMA), free fatty acids and glycerol dosages, 6- lipids enzymes, lipidome and functionality of HDL in sub-groups of SCD population.

Impact of Golden Rice-Piper Crocatum Cookies on Lipid Control in Diabetes Mellitus Patients

People with diabetes often experience abnormal blood fat levels, known as dyslipidemia, which increase the risk of heart disease and stroke. The aim of the study, researchers are exploring a natural and practical solution through a healthy snack in the form of cookies. These cookies are made from Golden Rice, which is rich in beta-carotene as a natural antioxidant, and Piper crocatum (red betel leaf) extract, which contains polyphenols and flavonoids that may help lower cholesterol, reduce inflammation, and protect blood vessels. In this study, patients with diabetes will consume the cookies for 28 days, and their blood fat levels will be measured before and after the intervention. The results will then be compared with those of a control group who receive the Golden rice cookies without piper crocatum extract. This research aims to show that Golden Rice with Piper crocatum extract cookies can reduce bad cholesterol and triglycerides, increase good cholesterol, and serve as a safe, affordable, and acceptable food option to support daily diabetes care. If successful, this approach may offer patients and families a simple way to help prevent complications and improve quality of life, alongside regular treatment and lifestyle changes.