Clinical Research Directory

PKP2-ACM Natural History Study

The goal of this study is to describe the natural history and clinical events for patients who have Arrhythmogenic Cardiomyopathy with Pathogenic Plakophilin-2 Variants (PKP2-ACM) managed with standard of care.

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.

Effects of External Upper Limb Loading on Gait and Trunk Muscle Activity in Cardiac Rehabilitation Patients

This study examines how external loading applied to the upper limbs affects gait parameters and the activity of selected trunk- and pelvis-stabilizing muscles (erector spinae, gluteus medius, tensor fasciae latae, external oblique) in patients undergoing cardiac rehabilitation. Participants are medically stable adults (18-80 years) referred to cardiac rehabilitation following a cardiac event or procedure, meeting NYHA class I-II criteria, with no unstable coronary disease, uncontrolled hypertension, neurological disease, or other exclusion criteria. Participants will walk on a treadmill at 1 km/h, 3 km/h and 5 km/h under three conditions: without load, with unilateral upper-limb loading, and with bilateral upper-limb loading. Muscle activity will be recorded using surface electromyography (sEMG), and plantar pressure/gait parameters will be recorded simultaneously using baropodometry integrated into the treadmill. The procedure is non-invasive, does not breach the skin, and does not involve any additional intervention beyond standard rehabilitation. To contextualize functional outcomes, previously collected exercise stress test results (performed independently by the treating physician before and after cardiac rehabilitation, as part of routine clinical care) will be retrieved from participants' medical records for comparison; this is a retrospective data comparison, not an additional study intervention. No financial compensation is provided. Each participant will receive an individual report of their sEMG and gait findings with professional interpretation. Risks are minimal and limited to transient skin irritation from electrodes and mild, temporary muscle fatigue or soreness typical of moderate exercise. Participants may withdraw at any time.

People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents

Background: Chronic hepatitis C infects the liver. It may scar the liver. This is called cirrhosis and may lead to liver cancer or death. Current chronic hepatitis C treatments cure most people. But some keep getting complications even after it is cured. Researchers want to study why. Objective: To study the course and complications of liver disease after cure of hepatitis C infection. Eligibility: Adults 18 years and older infected with chronic hepatitis C virus who were never treated or were treated and not cured and those who were cured Design: Participants will be screened with: Blood and urine tests Questionnaires Liver ultrasound Fibroscan. A probe vibrates the liver, testing stiffness. In Phase 1, people with chronic hepatitis C will: Have a 3-day hospital admission to repeat some screening tests and have a liver biopsy. A small piece of liver is removed by needle passed through the skin. Take 1 tablet containing 2 hepatitis C drugs once a day for 12 weeks. Repeat some blood tests at 3 visits in those 12 weeks while on treatment, then 4 additional visits in the next 24 weeks with more blood work collected. Phase 1 participants who test negative for hepatitis C and all other eligible participants will enter Phase 2. Phase 2 participants will have a visit every 24 weeks for 10 years. These may include: Repeats of screening tests Questionnaires Scans Stool tests Chest x-ray Heart function test Endoscopy. A tube guides a camera into the upper digestive system. At about 5 years, participants will have another liver biopsy. Some participants will give separate consent for genetic testing and a special blood procedure....

Sympathetic Activity in Post-injury Outcomes: Impact on Sleep and caRdiovascular Health InvesTigation

The goal of this observational study is to learn about the long-term health of United States military service members who were injured during combat. The main questions it aims to examine are: * How does the severity of a combat injury impact 1) cardiovascular risk, 2) the sympathetic nervous system and arrhythmias, 3) blood pressure, and 4) sleep disorders? * Are self-reported mental health symptoms related to sympathetic nervous system hyperactivity, sleep disorders, and cardiovascular risk in combat-injured service members? This study will recruit from a sample of participants in another research study called the Wounded Warrior Recovery Project (WWRP) who 1) agreed to be contacted about future research studies and 2) have a record of a combat injury within the Injury Severity Score ranges required for this study. Participants will: * Provide demographic information and a medical history review * Visit a local laboratory for biometrics measurements and to provide blood and urine samples * Wear an ambulatory electrocardiogram monitor for 24 hours per day for seven consecutive days * Wear a home sleep test monitoring device for one night * Wear a blood pressure monitor for 24 consecutive hours on the day after the home sleep test At the end of the study, participants will be asked to mail back the home sleep test and blood pressure monitors. Prepaid package materials will be provided.

Intrahospital Influenza Vaccination in Patients at High Cardiovascular Risk (VACC-UP)

The aim of this study is to evaluate the effect of offering intrahospital influenza vaccination as an adjunct to active counseling during the index hospitalization to adult patients hospitalized for acute coronary syndrome (ACS) or congestive heart failure (CHF), compared with active counseling alone, on influenza vaccination rates in patients at high cardiovascular risk. Patients are randomized 1:1 to either an offer of bedside intrahospital influenza vaccination according to the recommendations of the German Standing Vaccination Committee (STIKO) in addition to standardized active counseling (intervention group), or standardized active counseling plus the standard-of-care recommendation for ambulatory vaccination in the discharge papers (control group). The primary endpoint is the influenza vaccination rate at the end of the index season (March 31).

American Indian Chronic Renal Insufficiency Cohort Study (AI-CRIC Study)

Despite many advances in our understanding of the natural history and progression of chronic kidney disease (CKD) and cardio vascular disease (CVD) in the parent CRIC study over the past 15 years, important questions about key risk factors for these diseases remain unanswered in the AI population. To address this burden of CKD in AI communities Investigators formed a consortium of investigators with extensive experience in conducting research of chronic diseases including diabetes, cardiovascular and kidney disease in AIs of Southwestern US. The proposed CRIC ancillary cohort study of 500 AIs (AI-CRIC) will rapidly improve our understanding of both potential risk factors for CKD progression, as well as the scope of this disease among AIs. This study leverages the current CRIC study and incorporates the planned activities of the next phase of the study - "CRIC 2018" - by implementing contemporary CRIC protocols for kidney and cardiovascular measurement and outcomes.

Bioequivalence Study to Compare Empagliflozin/Linagliptin/Metformin HCl25 mg/5 mg/1000 mg Extended Release Tablet Versus Trijardy® XR 25 mg/5 mg/1000 mg Extended- Release Tablets

An open label, randomized, two-period, two treatment, two-sequence, crossover, balanced, single dose oral bioequivalence study to compare Empagliflozin/ Linagliptin/ Metformin HCl 25 mg/5 mg/1000 mg Extended Release Tablet versus Trijardy® XR (Empagliflozin/linagliptin/metformin hydrochloride extended-release tablets 25 mg/5 mg/1000 mg) in healthy subject in fast condition.

A Study on Abnormal Menstrual Bleeding in Chinese Women of Childbearing Age Taking Antithrombotic Drugs After Cardiovascular Surgery

This study aims to investigate uterine bleeding during menstruation in women taking antithrombotic medications after cardiac surgery. It will evaluate the proportion of patients with abnormal bleeding, such as heavy menstrual bleeding and prolonged menstrual periods, identify associated risk factors, and determine the characteristics of high-risk female patients.

A Prospective, Randomized Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation.

Pivotal trial to evaluate the safety and effectiveness of the P\&F TricValve® Transcatheter Bicaval Valve System.

COINCIDE: Cardineurovascular dIsease and Obstructive Airway Disease

Patients with chronic obstructive pulmonary disease (COPD) and severe asthma frequently present with cardiovascular comorbidities that contribute substantially to morbidity and mortality. Early identification and appropriate management of cardiovascular disease are increasingly recognized as important components of comprehensive care for patients with obstructive airway diseases. The COINCIDE study is a prospective longitudinal observational cohort study conducted at the Department of Pulmonology, Medical University of Innsbruck. The study aims to systematically document cardiovascular comorbidities in patients with COPD and severe asthma and to evaluate their association with disease progression, therapeutic management, exacerbation rates, symptom burden, and pulmonary function over time. Clinical, functional, laboratory, and imaging data obtained as part of routine clinical care will be collected prospectively during two study visits separated by approximately 24 months. Up to 350 adult participants will be enrolled and followed over a period of five years.

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....

EValuation Of poLygenic Scores and CT imAging In Risk Factor Modification in Patients With diabEtes

This study is a three-arm, parallel-group, randomised controlled trial evaluating the effect of using cardiac CT imaging or polygenic risk score in cardiovascular risk factor modification in patients with diabetes.

A Study to See if Lepodisiran Can Reduce Plaque in Coronary Arteries of Adults With Elevated Lp(a) Who Have Had Heart Events or Are at High Risk

Lipoprotein(a), also known as Lp(a), is a protein that carries cholesterol and proteins in your blood. People with high Lp(a) have a higher risk for heart disease. The main purpose of the study is to investigate how lepodisiran, compared to a placebo, affects the amount and type of plaque in the heart's vessels using an imaging technology known as Coronary Computed Tomography Angiography (CCTA) in adults who have high levels of Lp(a). Participation will last about 120 weeks.

Guideline Oriented Approach To Lipid Lowering In Asia-Pacific

Multinational, patient-level randomised, multi-phase standard-of-care control arm, parallel group, implementation study. Patients will be recruited during hospitalisation and be randomised to a multifaceted intervention to be delivered either 'early' (baseline) or 'late' (6 months), in a 1:1 fashion.

NightWare and Cardiovascular Health in Veterans With PTSD

The purpose of this study is to learn more about the effectiveness of a prescription wrist-wearable device called NightWare (NW) on improving sleep in Veterans with nightmares related to posttraumatic stress disorder (PTSD). The investigators also want to learn whether it improves cardiovascular health among this population.

Cardiovascular Risk Factors in Mexican Women

Cardiovascular disease is a major cause of morbidity and mortality among women. Cardiovascular risk in women is influenced not only by traditional risk factors, but also by sex-specific factors and social determinants of health. However, information on the distribution and relative importance of these factors among Mexican women remains limited. REFARCAM Mx is a multicenter, observational, cross-sectional registry designed to estimate the prevalence and describe the distribution of traditional, sex-specific, and emerging cardiovascular risk factors, as well as social determinants of health, among adult female beneficiaries of the Mexican Social Security Institute (IMSS) receiving care at participating medical units in Mexico. Approximately 3,000 women aged 18 years or older will be enrolled across 36 IMSS medical units representing the three levels of healthcare. Participants will complete the validated REFARCAM Mx questionnaire administered by trained personnel using a secure digital platform. Clinical and anthropometric information, including blood pressure, weight, height, and heart rate, will also be collected, and available clinical information will be verified using the institutional medical record. In women aged 40 to 74 years, cardiovascular risk will be estimated using the HEARTS for the Americas cardiovascular risk calculator. The collected information will be used to characterize cardiovascular risk in women receiving care at participating IMSS centers and to explore factors associated with previous cardiovascular events. Statistical analyses will include conventional multivariable methods and machine-learning approaches to identify relevant patterns and predictors of cardiovascular risk.

IAMABLE: Implementation and Evaluation of an App for Evidence-Based Self-Management Rehabilitation Strategies

Background: As the population gets older, a rise in chronic conditions has resulted in increased demand for rehabilitation. We developed a web-based app called IAMABLE (I am able), to share evidence-based rehabilitation strategies with people with chronic conditions. Our project will guide us to test this app's effectiveness and explore the ways that people use it. Goals, Methods, Approach: This pilot randomized controlled trial will offer people receiving the intervention access and use of the IAMABLE app for 4 months. People in the comparison group will have access to general web-based health information. We will recruit 50 people, 45 to 75 years, with at least one chronic condition; we will advertise in five communities (Hamilton, Kingston, London, Halifax, Winnipeg) to evaluate feasibility of the study design. Patients, therapists and app experts will be an expert group to study how the app encourages people to start and continue to use it. We will use patient-reported measures to determine if the people in the IAMABLE group experience better function; quality of life, mobility, participation, self management, pain, health service use, and falls are secondary outcomes. We will measure outcomes at baseline, 4 and 8 months. Research Team: Our team is led by researchers with experience in rehabilitation and chronic disease management, including testing technology innovations. Patient advisors will support the project, along with co-investigators with expertise in statistics, technology, and rehabilitation research. Expected Outcomes: This research has the potential to prove how a web-based app can deliver occupational therapy and physiotherapy to support health and well being for people with chronic conditions. After this study, we plan a larger trial that will focus on effectiveness and address sustained use. IAMABLE will become a resource for people with chronic illnesses to support their independent self-management with rehabilitation strategies.

Philly CEAL- DECIDE+ Adaptation

Cardiovascular disease (CVD) disproportionately affects racial/ethnic minorities and underserved populations in Philadelphia. This study aims to evaluate the effectiveness of an enhanced community health worker (CHW) program that combines the evidence-based DECIDE self-management intervention with structured CHW consultations to improve CVD self-management skills and address social needs. Using a Type 1 Hybrid Effectiveness-Implementation Design, we will recruit 500 Philadelphia residents aged 35-75 with CVD risk factors and unmet social needs. Participants will be offered the DECIDE+ intervention (9 bi-weekly group sessions plus alternating CHW consultations) or continue with standard CHW services. The primary outcome is CVD self-management skills measured by the Self-care of Chronic Illness Inventory Maintenance scale. Secondary outcomes include health behaviors and resolution of social needs. Implementation outcomes will assess CHW experiences, community advisory council impact, and factors influencing participation. Propensity score methods will be used to compare changes in outcomes between DECIDE+ participants and those receiving standard CHW services. Mediation analyses will examine pathways through problem-solving skills, self-efficacy, and social needs resolution. Mixed methods will evaluate implementation outcomes. This study will provide evidence on the effectiveness of integrating an evidence-based self-management program with CHW services to address both clinical and social needs. This study has the potential to generate important and impactful findings that can advance health equity and the science of effective community health worker programs. By rigorously evaluating the real-world implementation of a city-wide CHW-delivered chronic disease self-management program that also addresses collaborative approaches and support to addressing social needs, our findings can provide a roadmap for other communities looking to implement evidence-based interventions to reduce health disparities. Demonstrating improved CVD self-management behaviors and reduced social needs among Philadelphia residents receiving the DECIDE+ intervention would provide compelling evidence for the synergistic benefit of these services, and to sustain and scale up this model. OBJECTIVES: We propose both effectiveness and implementation questions to guide our work: Effectiveness of CHW Engagement: 1. Is the DECIDE intervention with CHW consultations (DECIDE+) effective in improving CVD self-management skills compared to the standard and limited CHW engagement? 1. Do DECIDE+ sessions improve CVD self-management skills by strengthening problem solving and self-efficacy? 2. Does participation in CHW consultations improve CVD self-management skills by meeting social needs? Implementation Questions: 2. What key sociodemographic and psychosocial factors influence client participation in the study? 3. How do CHWs perceive the impact of facilitator training on their a.) knowledge, attitudes and practices in supporting clients b.) personal health management, and c.) job satisfaction? 4. How does the CAC facilitate resource mobilization to enhance access to services that address social needs in Philadelphia's communities?

A Randomized Placebo-procedure Controlled Trial of the Enhancor System (PULmonary Artery Denervation) to Evaluate Safety and Efficacy in Patients With Combined Pre- and Post-capillary Pulmonary Hypertension Associated With Left Heart Disease

The goal of this clinical study is to evaluate the safety and efficacy of percutaneous pulmonary artery denervation with the Multi-Pole Pulmonary Artery Radiofrequency Ablation Enhancor System in patients with combined pre- and post-capillary pulmonary hypertension (CpcPH) associated with left heart disease (LHD). This randomized control trial will compare the investigational device (The Enhancor System) to control (medical therapy.) Participants who will consist of patients with chronic heart failure (HF) who are receiving maximally tolerated guideline-directed medical therapy (GDMT) for left heart failure, are clinically stable, and who have been diagnosed with CpcPH by right heart catheterization (RHC), will be treated with PADN and followed for 3 years.

Thrombosis and Inflammation in Vessels Initiative (TIVI)

Background: Diseases related to the immune system, blood clots, and blood vessels can affect every part of the body. These diseases are now known to be interrelated: People who have strokes, blood clots in their legs, or autoimmune disease, for example, are at greater risk of complications in the heart, brain, and other organs. Researchers want to learn more about how these diseases start, how they change over time, and how they affect different organs. Objective: To learn more about how inflammation and diseases of the blood vessels start and how they change over time. Eligibility: People aged 5 years and older with a disease related to blood clots, the immune system, or blood vessels. Healthy relatives of people with these diseases and unrelated healthy volunteers are also needed. Design: Participants will have a baseline visit: They will provide a medical history, physical exam and blood test. All other tests and procedures are optional; these may be spread over more than 1 day: Tests of heart and lung function. Fill in a family tree form. Imaging scans Treadmill or bike stress tests and a 6-minute walk test. Tests of blood pressure and the flow of blood through vessels. Photos of the face and body. Eye exams, with photos taken of the retina. Saliva and urine samples. Biopsies (tissues samples) of the skin and fat. Tests of thinking and mental function. Evaluations by other medical specialists. Participants may opt to return for repeat testing for up to 90 months (7.5 years). Some visits may be done by telehealth.

COLchicine and Non-enteric Coated Aspirin in the Cardiovascular Outcomes Trial of Patients With Type 2 Diabetes

To evaluate the efficacy and safety of colchicine and non-enteric coated aspirin, combined or alone, to improve cardiovascular outcomes in high-risk patients with type 2 diabetes.

A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension

Study ROR-PH-303, ADVANCE EXTENSION, is an open-label extension (OLE) study for participants with WHO Group 1 PAH who have participated in another Phase 2 or Phase 3 study of ralinepag.

The CLASP III TR CED Study

This Coverage with Evidence Development (CED) study measures the long-term health outcomes of patients with severe, symptomatic Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Repair procedure using the PASCAL Precision system.