Clinical Research Directory

A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight, Type 2 Diabetes, and Increased Cardiovascular Risk

The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with a placebo in participants with obesity or overweight, type 2 diabetes, and increased cardiovascular risk.

A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia

GESTA-SCORE is a prospective, randomized clinical trial designed to evaluate whether an early, personalized cardiovascular prevention strategy can achieve a clinically meaningful 6 mmHg reduction in systolic blood pressure at one year postpartum compared with guideline-based standard care in women with preeclampsia. Women with preeclampsia will be randomly assigned in a 1:1 ratio to one of two groups. The Intervention group will receive a structured cardiovascular prevention program based on early identification of cardiovascular risk factors, personalized clinical assessment, digital health monitoring and targeted preventive interventions. The Standard care group will receive postpartum care, including blood pressure assessment, antihypertensive treatment when indicated, cardiovascular risk management and clinical follow-up, in accordance with current clinical practice guidelines. All participants will receive appropriate medical care, and no clinically indicated treatment will be withheld. The study will also include two non-randomized observational comparison cohorts: women with other adverse pregnancy outcomes (APOs), such as gestational diabetes, preterm birth or fetal growth restriction, and women without APOs. These cohorts will help researchers understand differences in blood pressure evolution and cardiovascular recovery during the first year after childbirth. Participants will undergo an initial cardiovascular assessment during the first six weeks postpartum, followed by scheduled assessments at 3, 6 and 12 months after delivery. Blood pressure will be measured at each assessment using a validated automated upper-arm device and a standardized protocol. After five minutes of seated rest, three consecutive measurements will be obtained, approximately one minute apart. The average of the second and third measurements will be used as the blood pressure value for each assessment. The primary outcome will be mean systolic blood pressure at 12 months postpartum, comparing the Intervention and Standard care groups and adjusting for baseline systolic blood pressure measured during the first six weeks postpartum. The study is designed to detect a between-group difference of 6 mmHg. Secondary objectives include evaluating hypertension, cardiometabolic and kidney health, lifestyle changes and differences in postpartum cardiovascular recovery between women with preeclampsia, other APOs and pregnancies without APOs. GESTA-SCORE aims to establish whether early, personalized cardiovascular prevention can improve blood pressure control beyond current guideline-based care and contribute to more effective cardiovascular prevention after pregnancy.

Threshold-Based Versus Range-Based Exercise Intensity Prescription in Cardiac Rehabilitation

Cardiac rehabilitation is an important part of the treatment of patients with cardiovascular disease. Supervised aerobic exercise improves physical fitness, functional capacity, and quality of life. However, the most effective method for prescribing exercise intensity during cardiac rehabilitation remains uncertain. The T-REXI-CR trial aims to determine whether prescribing aerobic exercise intensity based on individual ventilatory thresholds leads to greater improvements in functional capacity than the guideline-recommended approach based on heart rate reserve. This pragmatic, multicentre, randomised controlled trial will compare two exercise intensity prescription strategies in patients participating in cardiac rehabilitation programmes in Belgium. Participants will be randomly assigned to one of two groups: * Threshold-based prescription: Exercise intensity will be individually prescribed using the first and second ventilatory thresholds (VT1 and VT2) identified during cardiopulmonary exercise testing. * Range-based prescription: Exercise intensity will be prescribed using the guideline-recommended range of 40-69% of heart rate reserve. Both groups will participate in a 15-week supervised aerobic exercise programme, targeting 40 exercise sessions. The programmes will follow the same training structure and progression principles, differing primarily in the method used to determine exercise intensity. The study will assess whether threshold-based exercise prescription provides additional benefits compared with conventional range-based prescription, with the aim of informing clinical practice and improving the delivery of cardiac rehabilitation.

Usefulness of Cardiovascular Disease (CVD) Management Solution

We previously developed the smartphone app (Heart4U) which is coupled with electronic medical record system in Seoul National University Bundang Hospital. In this study, we aim to evaluate clinical usefulness of smartphone app regarding the control of conventional risk factors in patients with history of cardiovascular disease.

Cardiovascular Disease Multimorbidity

This is a hybrid type II effectiveness-implementation trial using a parallel cluster randomized design. Thirty primary healthcare centers (PHCs) in Akwa Ibom State, Nigeria, will be randomized in a 1:1 ratio to the implementation group (Practice Facilitation \[PF\] + Healthy Lifestyle Counselling, Evidence-Based Protocols, Access to Essential Medicines and Technology, Risk-Based Management, Team-Based Care, and Systems for Monitoring \[HEARTS\] package) or the standard care group (HEARTS only) The study comprises two phases: an R61 Initiation Phase (Years 1-2) involving adaptation of the HEARTS package guided by the chronic care model, stakeholder engagement, infrastructure development, and pilot testing in 2 PHCs; and an R33 Implementation Phase (Years 3-5) involving the cluster RCT. Once randomized, PHCs will participate in a 12-month intervention period followed by a 6-month post-implementation period.

A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium (The Optimal Trial)

The OPTIMAL randomized clinical trial has been designed to compare two imaging strategies and to test the hypothesis that a calcium modification strategy informed by coronary CT angiography (CCTA) will improve procedural efficiency and effectiveness compared with the current standard of care (IVUS-guided PCI) while achieving similar clinical outcomes in patients with hemodynamically significant calcified coronary artery disease.

Impact of Patient-Centered Approach for Communicating Coronary Calcium on Cardiovascular Health

This multicenter clustered randomized prospective study will be managed by the American College of Radiology Center for Research and Innovation (ACR CRI). The research team aims to test the efficacy of a patient-centered educational intervention based on coronary artery calcification (CAC) information in cardiovascular risk factor modification of a cohort of patients enrolled in lung cancer screening (LCS) programs across the country.

Effect of Propionic Acid Supplementation on Endothelial Function

Coronary Artery Disease (CAD) remains a leading cause of morbidity and mortality worldwide despite improved mitigation of traditional risk factors. Large association studies have linked the gut microbiome alterations with inflammation, CAD, and traditional CAD risk factors. Subsequent studies have shown concomitant improvements in gut dysbiosis, inflammation, and cardiometabolic diseases using probiotics and other gut-modulating therapies. To date, many studies have shown a correlative relationship between intestinal bacteria composition and the presence of CAD, or severity of heart attacks, but few have begun to elucidate potential metabolic and immunologic mechanisms. The investigator's recently supplemented Lactobacillus plantarum 299v in men with stable CAD, which improved systemic inflammation and brachial artery flow-mediated dilation (BA-FMD) - a measure of endothelial function and a predictive CAD precursor. Improvement in BA-FMD positively correlated with increased serum propionic acid (PA) concentrations. PA is a gut microbiome-derived short chain fatty acid (SCFA) with known human vascular receptors and implicated in endothelial function, innate immunity, and glucose homeostasis. Whether PA is mediating improvement in endothelial dysfunction or inflammation in the investigator's prior experiment remains unknown. The investigator's objective is to determine whether endothelial cell function is improved by dietary supplementation of sodium propionate in patients with established coronary artery disease. Furthermore, the investigators wish to elucidate to what extent inflammation is reduced by this therapy, by both measuring serum inflammatory markers and by seeing if plasma from treated patients induces anti-inflammatory transcriptomic responses from cultured endothelial cells and peripheral blood mononuclear cells, both of which are involved in atherosclerosis. Specific Aim 1 will determine the impact of dietary PA supplementation on endothelial function and traditional CAD risk factors in patients with CAD. The investigators will utilize ultrasound to assess the percent change in BA-FMD before and after dietary PA supplementation. The extent of endothelium-dependency of these responses will be tested by measuring BA-FMD following nitroglycerin administration. The investigators will also measure markers representative of traditional CAD risk factors, such as lipid levels and HgbA1C. Specific Aim 2 will determine anti-inflammatory changes in vivo and in transcriptomic signatures of cultured EC and PBMCs induced by dietary PA. The investigators will measure changes to systemic serum inflammatory markers involved in atherosclerotic processes using a targeted metabolomics approach, using plasma from the investigator's cohort before and after PA supplementation. Plasma samples will be used to incubate aforementioned cells to compare transcriptomic signatures of cells subjected to pre-supplementation plasma versus post-supplementation plasma. The investigators will use Ingenuity Pathway Analysis to determine changes to inflammatory pathways and i.i.com to determine whether more anti-inflammatory signatures were induced. Specific Aim 3 will determine the impact of PA supplementation on gut microbiome taxonomy and diversity. As an optional additional clinical study activity, the investigators will collect stool samples before and after dietary PA supplementation, subject samples to multiplex 16S RNA sequencing, and calculate the Shannon Diversity Index. This will help us determine changes in individual gut microbiome constituents and diversity of the entire population.

Prevention of Cardiovascular Disease and Mortality in Patients With Psoriasis or Psoriatic Arthritis

The goal of this research is to test a novel centralized care coordinator program to assist patients with psoriatic disease in lowering their risk of cardiovascular disease through the application of standard of care approaches to improving modifiable cardiovascular risk factors.

The TRICURE EFS Study

Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System

Diabetes and Heart Disease Risk in Blacks

It is unknown if obesity contributes to the development of heart disease in African American men and women. This study was created to determine whether there is a relationship between sex and body size and the incidence of heart disease in African American men and women. Researchers will attempt to associate obesity with the presence of heart disease risk factors. Risk factors that will be studied include; total body fat, body fat distribution, fat content of the blood (triglyceride concentration, low density lipoproteins \[LDL\], and high density lipoproteins \[HDL\]), how fast fat is removed from the blood, and how well insulin works in the body. Scientific studies have shown that obesity and increased levels of fat content in the blood are important risk factors for heart disease in Caucasian women. However, similar studies in African American women have failed to show the same correlation. In fact, it appears that African American women in all three body weight groupings, nonobese, overweight, and obese experience high death rates due to heart disease. In addition, prior research has shown that obese African American men tend to have elevated levels of fat in the blood while African American women have normal blood fat levels. Therefore, if high levels of triglycerides (fat found in the blood) are not seen in non-diabetic obese African American women, it cannot be considered a risk factor in this population. This suggests that studies conducted on Caucasian women may not provide insight into heart disease risk factors in African American women. The study will take 2000 healthy non-diabetic African American men and women (ages 18-70) and body mass index 3 subgroups; nonobese, overweight and obese. Diabetes undeniably increases the risk of heart disease. Therefore patients suffering from diabetes will not be included in the study. Candidates for the study will undergo a series of tests and examinations over 2 outpatient visits. Subjects will have body fat analyses, resting energy expenditure measurements, an EKG (electrocardiogram), and specific blood tests. Researchers believe this study will provide significant insight into the causes of obesity and heart disease in African Americans....

Real-life Registry in Patients With Coronary Artery Disease Treated With the SELUTION Sirolimus-eluting Balloon. Selution Iberia Registry

Selution Iberia registry is a post-market clinical follow-up, prospective, multicenter, international, longitudinal, observational study without a control group of consecutive unselected "real-world" patients with coronary artery disease in whom it was decided to use the SELUTION SLRTM device in the treatment of primary native lesions and ISR (in-stent restenosis) in all settings, in order to evaluate its effectiveness and safety. The primary objective is to evaluate the effectiveness and safety of the Sirolimus-eluting balloon SELUTION SLRTM based strategy in the treatment of native coronary artery stenosis and in-stent restenosis. The primary endpoint will be the incidence of major adverse cardiovascular events at 12 months, including death, non-fatal myocardial infarction or target lesion revascularization for ischemia, in an unselected "real-world" patient setting. Both Device Oriented Composite Endpoint (Cardiovascular death, device failure-related myocardial infarction or device failure-related ischaemia) and Patient Oriented Composite Endpoint (all cause death, any stroke, any myocardial infarction or any revascularization) will be detailed.

Techquity by FAITH!

The goal of this clinical trial is to engage African-American churches via an established community-academic partnership (FAITH! Program) to build capacity to promote cardiovascular health and digital health equity in African-American faith communities. There are 3 study aims: Aim 1: Co-design a culturally tailored digital health equity toolkit with community members Aim 2: Train a network of Digital Health Advocates (DHAs) in digital health equity and cardiovascular health promotion Aim 3: Test the impact of a DHA-enhanced mobile health intervention (the FAITH! App) on cardiovascular health and digital health readiness among participants In Aim 1, participants will attend a series of focus groups to share their input on a digital health equity curriculum that will be condensed into a toolkit. In Aim 2, DHAs will be trained using this toolkit as well as a community health advocacy curriculum to learn how to promote digital health readiness and cardiovascular health in their communities. Finally, Aim 3 will be a randomized controlled trial where participants will use the FAITH! App to improve their cardiovascular health. Some participants will have the added support of a DHA, and the control group participants will use the app with no additional support to test whether the DHA support is associated with a more significant improvement in cardiovascular health.

Targeted Health Dialogues in Primary Care

The County Council of Region Skåne, Sweden, has recently initiated Targeted Health Dialogues in primary care. The prevention program includes health dialogues provided by specially trained personnel, collection of clinical and laboratory data as well as questionnaire data on, e.g., individual health and health behaviors. So far, it enrolls all 40-year old Swedish and foreign-born inhabitants in the county and it will also include all 50- and 60-year old persons within a near future. A research project will be integrated within the program where the collected data will be linked, on the individual level, to national and regional data on hospital admissions, clinical diagnoses from specialist clinics and primary care, causes of death, and prescriptions. The individual linkages will also include population data on sociodemographic characteristics, neighborhood of residence and family relations. Blood samples will be collected for analyses of molecular biomarkers. The research project will examine associations between potential predictors and future risk of cardiovascular diseases and other serious diseases, such as cancer, and also whether the effect of the prevention program is modified by these potential predictors. The effect of the intervention will be examined, and whether the protocol needs to be modified in order to develop more precise and personalized medicine.

Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes

The DIACTIVE study is a randomized controlled trial with a 5- year follow-up designed to evaluate the impact of comprehensive screening and multicomponent interventions on fall prevention, bone health, nerve function and cardiovascular outcomes in people with diabetes aged 65 years and older on the short and longer term. Diabetes significantly increases risks of falls, fractures, and cardiovascular disease, yet these areas remain underexplored in clinical research. This trial addresses these gaps with a novel, multidimensional approach. Participants undergo extensive baseline assessments, including fall risk stratification, bone mineral density measurements via DXA scans, neuropathy evaluations, and cardiovascular profiling. Based on these evaluations, participants are allocated to risk-based intervention arms. The study's centerpiece is the RYMA and ADL exercise program, a tailored cognitive-motor training regimen integrating strength, balance, and executive function exercises with music-based coordination tasks. Pharmacological treatments for osteoporosis and optimization of cardiovascular risk profiles (e.g., SGLT2 inhibitors, GLP-1 agonists) are also incorporated. Primary outcomes focus on reducing fall rates by at least 30%, improving bone density, mitigating fracture risks, enhancing nerve function, and lowering cardiovascular event rates. Secondary endpoints explore mechanisms underlying fall reduction, quality of life improvements, and adherence to interventions. Advanced methodologies such as gait analysis, seismocardiography, and magnetic resonance imaging (MRI) provide detailed insights into the intervention's effects. Follow-ups at 26 weeks, 52 weeks, 2 years, and 5 years ensure long-term efficacy evaluation. This trial is conducted at Steno Diabetes Center North and involves interdisciplinary collaboration. By addressing key complications of diabetes through integrated care, the study aims to improve patient outcomes and inform future healthcare strategies for older people with diabetes.

EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease

This study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease. People can join the study if they have these conditions and do not have a history of heart failure. The purpose of this study is to find out if a medicine called vicadrostat, when taken with empagliflozin, helps reduce cardiovascular risk in people with these conditions. The study will compare this combination to a placebo version of vicadrostat with empagliflozin. Participants are put into 2 groups randomly, which means by chance. One group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets with empagliflozin. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take a tablet once per day for 2 and a half years and up to 4 years and 3 months. All participants also continue their medication for type 2 diabetes, high blood pressure, and cardiovascular disease. Participants have an equal chance of receiving the study medicine or placebo. Participants are in the study for up to 4 years and 3 months. During this time, they visit the study site regularly. During these visits, doctors collect information about participants' health and take blood samples. The doctors document when participants experience cardiovascular events. The doctors also regularly check participants' health and take note of any unwanted effects.

A Post-Approval, Single-Arm Study of the SYNERGY Stent System in China

A prospective, observational, single-arm, open-label, multicenter, post-approval study. To compile real-world clinical outcomes data for the SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGYTM Stent System) in real-world clinical practice in China.

Effects of NT-0796 in Obese Participants at Risk of Cardiovascular Disease

This trial is a Randomized, Double-Blind (Sponsor-Open), Placebo-Controlled Study to Assess the Effect of NT-0796 on Inflammation in Obese Participants at Risk of Cardiovascular Disease. Participants will be admitted to an in-patient Clinical Research Unit on Day -1 and will be discharged on Day 30. The trial will include a 7-day out-patient safety follow-up period following the last dose of study treatment. For the first approximately 20 participants effect of food will be evaluated on the Pharmacokinetics of NT-0796. MRI's will be conducted in a subset of participants.

TRISCEND JAPAN Study

A prospective, open, non-randomized, multicenter, clinical trial to evaluate the safety and effectiveness of the Edwards EWJ-202 transcatheter tricuspid valve replacement system in the treatment of patients with at least severe tricuspid regurgitation despite medical therapy. Subjects will be followed at discharge, 30 days, 6 months and annually through 5 years.

Generative AI Impact on Rheumatoid Arthritis Complications Diagnosis

Generative AI (GenAI) based on large language models (LLMs) is expected to improve the diagnosis and treatment of autoimmune diseases. We are studying how GenAI may affect the diagnosis of various complications of rheumatoid arthritis (RA). In a retrospective study using RA patients' EHR records, we will quantify physician adoption of GenAI predictions for RA complications and co-existing diseases. In a prospective observational study, we will assess the feasibility of using GenAI predictions as additional clinical information to help physicians make more complete diagnoses of RA complications and co-existing diseases, including complex, uncommon, or rare conditions.

Fibrotic Disease Activity in Cardiopulmonary Disorders Using 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) PET/CT Imaging

Background: Injury or diseases of the heart and lung can sometimes cause scar tissue (fibrosis) to build up in those organs. Current imaging scans can see this scar tissue once it has formed, but researchers want to find a way to detect the fibrosis in its earliest stages, while there might still be time to prevent serious damage. A new tracer (a radioactive substance injected during imaging scans) may be able to help. Objective: To test a new tracer (18F-FAPI-74) during imaging scans in people with heart or lung disease. Eligibility: People aged 18 years and older with lung or heart disease that may cause scarring in those organs. Design: Participants will have 6 clinic visits over 2 years. Participants will be screened: They will have blood tests and tests of their heart and lung function. Those with heart disease will have a magnetic resonance imaging (MRI) scan of the heart. The study tracer will be used with positron emission tomography (PET)/computed tomography (CT) scans. The study tracer will be injected into a vein in the arm. Participants will lie on a padded bed that slides through a donut-shaped machine. Participants will have scans with the study tracer 2 times, 8 to 12 months apart. They will also have standard CT scans and blood tests during these visits. They will also have blood tests at 3 and 6 months between these visits. Participants will have a follow-up visit after 18 to 24 months. The study scans, MRI and standard CT scans, and lung function tests may be repeated....

Intracardiac Echocardiography Catheter Supply-Chain Reliability and Clinical Access Study

The ICE-ACCESS study is a prospective observational study designed to evaluate how procurement reliability, distribution restrictions, supply-chain interruptions, and device availability affect access to intracardiac echocardiography (ICE) catheters and related clinical care. The study will document real-world procurement attempts, fulfillment outcomes, order delays, cancellations, product substitutions, distributor restrictions, acquisition timelines, and other supply-access events involving ICE catheter devices. Where participant-level clinical data are available under the approved protocol, the study will also examine whether device-access problems are associated with procedure delays, rescheduling, changes in planned device use, alternative sourcing, increased administrative burden, or other measurable effects on care delivery. The study does not assign participants to a device or treatment and does not alter clinical decision-making. Procurement and clinical events are observed as they occur in routine practice. The study is intended to develop a structured evidence base for understanding the reliability of the medical-device supply chain and the potential relationship between procurement disruption and timely access to cardiovascular procedures.

Study on Intervention Effect of Heat-related Health Risk Early Warning Digital Technology for School-age Children

This cluster randomized trial is conducted in Beijing primary schools to evaluate the efficacy of a WeChat mini-program-based high-temperature early warning intervention on the physical and cognitive health of school-age children. Six participating schools are randomly assigned to two parallel groups. The intervention group receives tiered heat alerts and guided self-health monitoring via the mini-program. The control group follows standard daily school and family routines, with no dedicated digital high-temperature early-warning intervention. The primary outcome is children's executive function after a 2.5-month follow-up. A range of secondary indicators related to physical status, mental health and health behaviors are assessed concurrently to quantify the intervention's benefits in mitigating adverse health outcomes caused by high temperatures.

A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation

To evaluate the feasibility and safety of the Millipede Transcatheter Annuloplasty Ring System in subjects with functional mitral regurgitation