Clinical Research Directory

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.

Observational Study for the Characterisation of Patients Affected by Any Type of Diabetes and Endocrine Disorders

The main objective of this retrospective and prospective observational register is to identify anthropometric, clinical, laboratory and/or instrumental markers of disease severity and activity in patients suffering from diabetes, endocrine-metabolic disorders, rare diseases in order to improve their diagnosis, monitoring and treatment processes. The Registry is monocentric, observational prospective and retrospective. No additional procedures to those of normal clinical practice are planned, and neither diagnostic approaches nor experimental drugs/prescriptions will be applied. The data under study (demographic, anthropometric, clinical and care characteristics) will be collected as part of outpatient visits of the Diabetes Outpatient Clinic or admission to Diabetes Day Hospital. In case of outpatients, the observation will start at the diagnosis or during the first outpatient visit and will end with the last outpatient visit performed within the total time foreseen for the duration of the study. The study will start once the regulatory authorizations are completed, and is expected to last at least 10 years with the possibility of extension

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.

Study of the Safety and Efficacy of Prenofitol Tablets

Stage 1 of the Study Stage 1 of the study will consist of: a screening period (Visit 0) conducted within 0-14 days prior to the start of treatment; an inpatient treatment period, including Visit 1 (Days 1-4) and Visit 2 (Days 7-8), during which blood samples will be collected for pharmacokinetic (PK) analysis and safety parameters will be assessed. Upon completion of the inpatient treatment period, the study data will be submitted to the National Center for Medicines and Medical Devices (NCMD) for analysis and assessment of tolerability and safety parameters. Based on the NCMD conclusion, a decision will be made regarding the feasibility of proceeding to Stage 2 of the study. an outpatient treatment period lasting for the subsequent 83 days (11 weeks), during which safety parameters will be assessed at the following time points: Day 28 (Visit 4), Day 56 (Visit 5), and Day 90 (Visit 7) from the start of treatment. Adverse events (AEs) and serious adverse events (SAEs) will be recorded at the above-mentioned visits and during telephone follow-up contacts at Day 14 (Visit 3) and Day 84 (Visit 6); a follow-up period lasting for the subsequent 90 days (up to Week 24 from the start of treatment). Safety parameters will be assessed by telephone follow-up at Day 120 (Visit 8), Day 150 (Visit 9), and at the final Visit on Day 180 (Visit 10). The treatment duration will be 90 days, and the follow-up period will be 90 days. The total study duration for each patient will be 180 days (approximately 6 months). Stage 2 of the Study Stage 2 of the study will consist of: a screening period (Visit 0) conducted within 0-14 days prior to the start of treatment; an outpatient treatment period lasting for the subsequent 90 days (12 weeks), during which safety and efficacy parameters and immune status will be assessed at the following time points: Day 1 (Visit 1), Day 7 (Visit 3), Day 28 (Visit 6), and Day 90 (Visit 8). Additional blood samples for immune status assessment will be collected on Day 2 (Visit 2), Day 14 (Visit 4), and Day 21 (Visit 5) from the start of treatment. AEs and SAEs will be recorded at the above-mentioned visits and during a telephone follow-up contact on Day 56 (Visit 7). Upon completion of the 90-day treatment period (Visit 8), the study data will be submitted to the National Center for Medicines and Medical Devices (NCMD) for assessment of safety and efficacy parameters. a follow-up period lasting for the subsequent 90 days (up to Week 24 from the start of treatment), during which safety and efficacy parameters and immune status will be assessed at Day 120 (Visit 9), Day 150 (Visit 10), and at the final Visit on Day 180 (Visit 11). The treatment duration will be 90 days, and the follow-up period after completion of treatment will be 90 days. The total study duration for each patient will be 180 days (approximately 6 months).

Improving Cardiovascular Health Risks in Adults With Epilepsy on a Modified Atkins Diet

Ketogenic diet therapies (KDTs) emphasize high fat and very low carbohydrate intake and help to control seizures in adults who fail to respond to medications. However, KDT use can lead to increased cholesterol levels in some adults with epilepsy (AWE). Treatments that can reverse elevations in cholesterol observed with long-term KDT use without compromising diet adherence and seizure control are needed. The proposed study will explore the feasibility and safety of diet modification and statin use to lower cholesterol in this population. Study findings will help guide doctors utilizing KDTs in adults with epilepsy on how to approach managing elevations in cholesterol.

A Novel Digital Tool Clinicians 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 clinicians to use to Prioritize Personalize Prescribe EXercise (P3-EX) to patients with cardiovascular disease (CVD) risk factors. The investigators will recruit 24 clinicians, including physicians, physician assistants, or advanced practice registered nurses, from two local hospitals in CT, USA. Clinicians will recruit two patients each (N=48) having CVD risk factors. Clinicians 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. Clinicians 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 clinicians 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 clinicians to use to prescribe customized exercise routines for patients with CVD risk factors, and clinicians and patients will be satisfied with P3-EX.

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.

Time-Restricted Eating With or Without Energy Restriction in Dyslipidemic Women With Owerweight or Obesity

Background/Objectives: It is unclear whether the effects of time-restricted eating (TRE) on body composition and blood lipids are independent of energy restriction (ER), and whether combining the two confers additional benefit. Methods: In this prospective, 8-week, three-arm, parallel-group randomized controlled trial, 85 sedentary women aged 19-65 years with overweight/obesity and untreated dyslipidemia were allocated to TRE (16:8, ad libitum intake within a 12:00-20:00 window), ER (individually calculated diet providing approximately 500 kcal/day below total energy expenditure) or TRE + ER. Anthropometry and bioelectrical impedance analysis were performed at baseline, week 4 and week 8, and fasting biochemistry at baseline and week 8.

Evaluation of an Integrated, Digital, Nurse-led, Remote Monitoring Care Pathway for Cardiovascular Risk Management

The goal of this observational study is to evaluate the implementation of a structured, digital, nurse-led, remote monitoring care pathway for cardiovascular risk management (CVRM). Participants will receive this care as part of routine clinical practice. In addition to standard follow-up, participants will complete questionnaires on quality of life, medication adherence, system usability, and patient satisfaction.

A Retrospective Real-World Cohort Study

The primary objectives are to determine the prevalence and overlap of major cardiometabolic diseases, identify multimorbidity clusters, and characterize demographic, clinical, laboratory, and treatment patterns across the cohort and relevant subgroups. This study is based on anonymized electronic health record (EHR) data and spanning January 2022 to December 2025. EHR will be extracted from participants of Acibadem hospital network in Turkey. Participants received routine clinical care according to physician discretion. Index date will be defined by the first diagnosis of cardiometabolic conditions. Follow-up period will include at least one year of to allow description of long-term outcomes. It will extend until the end of study, last recorded encounter, or death.

Patient-engaged Development and Testing of Educational Content on Side Effects of Statins

The purpose of this study is to learn about people's experiences and perspectives on side effects of statins and to use this information to develop and test educational content to help people understand statin side effects when they are newly prescribed a statin. Participants in the first phase of the study will fill out a survey and participate in a focus group or interview. Participants in the second phase of the study will view educational content, fill out a survey, and participate in two interviews.

Cardiovascular Risk Factors and Lipid Profile in Hospitalized Mexican Adults

Traditional cardiovascular risk models are limited in capturing functional alterations in HDL-C linked to smoking and diet in Latin American populations. We analyzed the relationship between traditional and non-traditional risk factors and the serum lipid profile of hospitalized Mexican adults, emphasizing HDL-C behavior.

Early Triple Lipid-Lowering Therapy With Bempedoic Acid After Acute Coronary Syndrome

This randomized clinical trial will evaluate whether starting bempedoic acid in addition to high-intensity statin therapy and ezetimibe within 72 hours after percutaneous coronary intervention improves low-density lipoprotein cholesterol (LDL-C) control in adults with acute coronary syndrome. Participants will receive either triple therapy with a high-intensity statin, ezetimibe, and bempedoic acid or standard dual therapy with a high-intensity statin and ezetimibe for 12 weeks. The primary outcome is the proportion of participants with LDL-C below 55 mg/dL at Week 12. Changes in lipid and inflammatory markers, medication adherence, and treatment-emergent adverse events will also be assessed.

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.

Polypills Approach for Multiple Cardiovascular Risk Factors

The Polypill Approach for Multiple Cardiovascular Risk Factors (PACIF) trial is a multicenter randomized controlled trial that will test the effectiveness and safety of a fixed-dose combination strategy for the integrated management of hypertension, dyslipidemia, and type 2 diabetes among adults aged 50 to 75 years without prior cardiovascular disease in China. The trial will evaluate whether a fixed-dose combination strategy improves the 10-year cardiovascular disease risk estimated using the PREVENT equations at Phase 1. Participants will be further followed to determine whether the fixed-dose combination strategy reduces major cardiovascular events and improves cognitive outcomes compared with usual care at Phase 2.

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.

Cottonseed Oil Versus Matched PUFA Effects

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 cholesterol profile and improve postprandial lipid and/or glycemic responses in both healthy, and at-risk populations. This study aims to compare CSO to a fatty acid composition-matched diet, on changes in fasting and postprandial lipid metabolism and markers of chronic disease risk. The specific aims are: * Examine the impact of CSO vs. PUFA on fasting and postprandial lipids. * Examine the impact of CSO on other markers of chronic disease risk. Participants will be asked to: * Consume provided meal replacement shakes daily for 28-days. * Attend three weekly short visits for fasting blood draws, body measurements, and collect the next week of 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 vs. PUFA and control groups (receiving a mixture of oils) to see if CSO is unique in imparting health benefits when compared with similar matched oil diets.

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.

Electronic Health Record Augmented LDL-Cholesterol Optimization and Control Via Active Lipid Engagement (EHR-LOCALE): A Quality Improvement Implementation Study

The purpose of this study is to determine whether a proactive, EHR-guided approach helps more individuals reach safe cholesterol levels, improves medication use, and reduces future heart attacks and strokes, compared to usual care. The main question it aims to answer is: • Does the EHR-LOCALE pathway increases the proportion of patients who reach the LDL-cholesterol target of \<1.8 mmol/L at 6 months? Participants in the interventional group receive: * Pharmacist contact * Repeat lipid requisitions * Review of medications, adherence, and side effects * Treatment escalation according to national dyslipidemia guidelines

Bioequivalence Study of AJU-C715 and C715R in Healthy Adult Volunteers

To Evaluate the Safety and Pharmacokinetics of "AJU-C715" and "C715R" in Healthy Adults.

A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD0780 in Healthy Subjects

This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD0780 following single and multiple dose administration to healthy subjects with or without elevated Low-Density Lipoprotein-Cholesterol (LDL-C) levels. This study will consist of two parts (Parts A and B). 56 subjects have been planned for Part A and 141 subjects for Part B. Additional subjects may be included for the optional cohorts depending upon emerging data.

Pilot Study to Evaluate the Effect of Nicotinamide Riboside on Immune Activation in Psoriasis

Background: Psoriasis causes chronic inflammation in the body. Researchers want to see if a kind of vitamin B3 dietary supplement can help. This might lead to more treatment options. Objective: To test if the dietary supplement nicotinamide riboside can improve immune system function in the blood and skin of people with mild to moderate psoriasis. Eligibility: People ages 18-80 with mild to moderate active psoriasis not currently treated with biological therapy Design: Participations will be screened with: * Medical and medication history * Physical exam * Measure of body mass index * Skin exam * Blood and urine tests Participants will have visit 1. They will have repeats of the screening tests. They may also have 2 skin biopsies, which are optional. These will be from both lesions and unaffected areas. The areas will be injected with a numbing medicine. A round cutting device will remove small pieces of skin from each area. Participants will take the study supplement or a placebo starting at the first visit. Neither participants nor the study team will know which they receive. Participants will take capsules twice daily for a total of 4 weeks. Participants will then have visit 2. This will include the tests performed at visit 1. Participants may by contacted by phone or email between visits to see how they are doing. If participants develop any side effects in the 7 days after they stop taking the capsules, they may have another visit.

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.

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.