Clinical Research Directory

Relationship Between Insulin Dose and Complications in Type 1 Diabetes

The goal of this observational study is to better understand how the amount of insulin people with type 1 diabetes are using relates to blood glucose control and the risk of complications. The main questions this study aims to answer are: 1) Is insulin dose related to the long-term risk of developing heart disease, kidney disease and other complications in people with type 1 diabetes, after accounting for blood glucose? and 2) Does insulin dose relate to early signs of heart and kidney disease (i.e., disease that is not clinically detectable) in people with type 1 diabetes who are using modern diabetes management regimens?

Impact of a Tailored Digital Intervention on Sedentary Behaviour and Physical Health in Long-term Cardiac Rehabilitation Patients

Sedentary behaviour (SB) is an independent cardiovascular risk factor that remains highly prevalent among individuals attending long-term cardiac rehabilitation (CR) programs, despite participation in regular supervised exercise. Although CR provides an ideal setting for promoting healthy lifestyle behaviours, evidence on tailored interventions specifically targeting SB in long-term CR programs remains limited. This randomized controlled trial aims to evaluate the effectiveness of a 6-month tailored behavioural intervention, supported by digital health tools, in reducing SB among adults attending a long-term phase CR program. Participants will be randomly allocated to either an intervention group (IG), receiving standard CR plus individualized behavioural counselling, digital prompts, and educational resources, or a standard care group (SCG) receiving usual CR and educational resources only. The primary outcome is objectively measured daily sedentary time assessed using activPAL4 (h/day). Secondary outcomes include objectively measured physical activity (PA), body composition, cardiorespiratory fitness, muscular strength, health-related quality of life and other behavioural outcomes. Outcomes will be assessed at baseline, 3, 6, and 12 months, according to the specific assessment schedule. The study aims to determine whether integrating a tailored behavioural intervention into routine long-term CR leads to sustained improvements in SB and related health outcomes.

Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System

The objective of this clinical study is to assess the safety and efficacy of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System for the treatment of symptomatic subjects with at least severe tricuspid regurgitation (TR).

Multi-organ Imaging of Microvascular and Metabolic Function

What if heart disease starts outside the heart? This research will study how to simultaneously assess brain and body physiology, how they are jointly related to heart function, and how their response to physical and mental stress differs in patients with heart disease.

Preventing Ischemic Heart Disease With mHealth (Mobile Health), Electronic Decision Support and Community Health Workers

This is a cluster-randomized clinical trial (cRCT) designed to assess the effectiveness of a multicomponent strategy linking key aspects of the cardiovascular disease (CVD) care continuum across three provinces in Argentina using using five primary components: a data management system linking a digital mHealth (mobile health) screening tool used by community health workers (CHWs), an electronic appointment scheduler which is integrated with the clinic electronic appointment system, point of care (POCT) testing for lipids, a clinical decision support system for medication initiation, and a text message (SMS) reminder system to improve treatment adherence and life-style changes.

Ambient Air and Noise Effect on Cardiovascular Health Risk and Lifestyle Intervention to Attenuate It (METSGREEN)

This study, combining both an observational study and an interventional clinical trial, aims to assess how exposure to ultrafine particulate matter (PM0.1) and noise pollution affects the risk of cardiovascular diseases and metabolic disorders in 45-64-year-old residents of Kaunas City, and whether lifestyle interventions-specifically physical activity in green spaces and the Mediterranean diet-can help reduce these risks. In the observational part, approximately 1,000 randomly selected 45-64 years men and women living in private households will complete an anonymous online health and lifestyle questionnaire. The clinical interventional trial will include 180 participants, who agreed to participate in the clinical study and, who meet specific health criteria. The main questions the study seeks to answer are: whether increased exposure to PM0.1 and noise is linked to higher cardiovascular and metabolic risk; and whether short-term healthy lifestyle changes can improve biological markers associated with these conditions. Participants in the clinical trial will be randomly assigned to one of three groups: (1) control group continuing usual habits, (2) physical activity group at least 30-minute daily walks in green spaces, or (3) group adherence to a Mediterranean diet. They will have two visits to the clinic for health surveys: * Wear a wristband sensor for 7 days to monitor physical activity, heart rate, and sleep quality * Visit a clinic on Day 1 and Day 8 for measurements (blood pressure, waist circumference, body composition) and give blood samples for biomarker analysis. This research will provide new evidence on environmental health risks and practical recommendations for reducing the burden of metabolic and cardiovascular diseases.

Reducing Arterial Inflammation Using Eplerenone and Statins in HIV

HIV has transitioned to a chronic disease in which well-treated persons remain at higher risk for heart disease when compared to the general population. Statin medications have been shown to reduce the number of events related to heart disease, but there are still individuals who will have complications from heart disease despite statin use. This study is being conducted to determine whether adding on another medication to statins called eplerenone, which has been shown to reduce inflammation in the heart vasculature among persons with HIV, can further decrease the risk of heart disease in HIV through its anti-inflammatory and blood pressure-lowering potential.

EValuation of prognostIc and Cost reDuction by tElemonitoring iN CIEDs Usual carE: an Updated Analysis Using 2019-2023 Data

The EVIDENCE-RM study is a nationwide, non-interventional retrospective study evaluating the clinical and medico-economic impact of remote monitoring (RM) in patients with an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D). Using data from the French national health database (SNDS) between 2019 and 2023, the study compares clinical outcomes and healthcare costs between patients with and without RM, as well as between those monitored via the universal Implicity platform versus conventional manufacturer-specific solutions.

Effectiveness of the "Aktivplan" Digital Intervention for Supporting Regular Heart-Healthy Physical Activity Following Phase II Cardiac Rehabilitation

After a cardiac event like a heart attack or heart surgery, regular heart-healthy exercise is important to reduce the risk of further cardiac events and improve quality of life. That is why patients are offered exercise-based cardiac rehabilitation programmes. In these programmes, patients learn under medical supervision how to safely exercise after the cardiac event. The idea is that, after completion of the programme, patients should then independently continue to regularly exercise during their everyday lives. But we know that many patients struggle to make heart-healthy exercise a habit during their everyday lives, even after completion of an exercise-based cardiac rehabilitation programme. Digital tools such as smartphone apps could be an option to help patients establish regular heart-healthy exercise in the long term. aktvplan is a digital tool that has been developed in Austria specifically for this purpose. We are now conducting a study to find out whether aktivplan does in fact help patient to regularly exercise in the long term after an exercise-based cardiac rehabilitation programme. aktivplan is an exercise scheduling app. At the end of the cardiac rehabilitation programme, the patient and the therapist discuss and agree on a suitable, personalised long-term exercise plan. The therapist then enters this exercise plan in the aktivplan app. The patient can view their personalised plan on the smartphone and check off completed exercise session. They also receive reminders and motivating messages to their smartphone. The therapist can see how many of the planned sessions the patient has completed. Should the patient struggle to complete the planned sessions, the therapist can contact the patient, discuss the reasons and possibly adapt the plan. In this study, 68 patients will be included at several cardiac rehabilitation centres in Austria. They will be part of the study for 12 months after completing the cardiac rehabilitation programme. They will be randomly divided into two groups. "Randomly" means that the decision is by chance, like tossing a coin. The first group will receive aktivplan for six months after completing the cardiac rehabilitation programme, and then they will not have aktivplan for the remaining six months in the study. The second group will be opposite, so they will not have aktivplan for the first six months and then receive aktivplan for the second six months. At the beginning, after six months and after 12 months, all patients will complete medical tests (exercise test, ultrasound of the heart, blood tests), measurements of their physical activity in everyday life (wearable sensor) and questionnaires (quality of life, self-confidence, anxiety). We will do statistical tests to compare how physically active and how physically fit the two study groups were at each of these time points. From this, we will be able to see whether aktivplan did in fact help these patients to regularly exercise in the long term.

wCAR-Austria: A Women-Specific Score to Assess Cardiovascular Risk in Women Aged 40 to 65

The wCAR-Austria Study is a multicentre, prospective, interventional study evaluating a novel women-specific cardiovascular risk score (wCAR) in 800 women aged 40-65 years across Austria. The wCAR score integrates conventional and women-specific cardiovascular risk factors - including hypertensive disorders of pregnancy, gestational diabetes, premature ovarian insufficiency, autoimmune disease, and menopause stage - into a three-axis, multiplicatively modular architecture. The study consists of two phases: A randomised, controlled interventional substudy (wCAR-CARE, PROBE design) allocates all participants with wCAR ≥ 11 points 1:1 to a structured precision-prevention arm (arm A, including tailored lifestyle intervention, structured statin evaluation, and menopausal hormone therapy counselling within the "window of opportunity") versus guideline-directed standard of care (arm B) for 24 months. Co-primary endpoints of Phase A are the area under the receiver-operating-characteristic curve (AUC) of the wCAR score for any coronary plaque (including non-calcified soft plaque on CCTA) in the intermediate stratum (E1a, n=100) and in the combined intermediate + high strata (E1b, n=200), analysed under a Bonferroni-Holm closed-testing procedure. The co-primary endpoint of wCAR-CARE is a composite risk-factor endpoint at month 24. The primary Phase B endpoint is time to first MACE. Secondary endpoints include reclassification improvement of wCAR versus SCORE2 and PREVENT, convergence validation against age-adjusted NT-proBNP percentiles, and convergence validation against high-sensitivity troponin-T using sex-specific thresholds per the Fifth Universal Definition of Myocardial Infarction (Mills et al., 2026).

VITAL: Real-World Evaluation of Amlodipine/Valsartan.

The goal of this observational study is to evaluate the effectiveness, safety, and treatment adherence of a fixed-dose combination of amlodipine and valsartan in adults with grade 2-3 hypertension in real-world clinical practice in Kazakhstan. The study will include patients who have already been prescribed the fixed-dose combination of amlodipine and valsartan (Agvistat®) by their treating physician as part of routine medical care, independently of their participation in the study. The main questions it aims to answer are: What proportion of participants achieve the target blood pressure after 12 weeks of treatment with the fixed-dose combination of amlodipine and valsartan? How well do participants adhere to treatment, and what patient characteristics are associated with treatment adherence? What changes occur in blood pressure, heart rate, quality of life, and selected laboratory measures during the 12-week observation period? What adverse events occur during treatment? Participants will: Have their clinical and demographic information and data from routine medical care recorded during the study. Have blood pressure, heart rate, and other relevant clinical data assessed during the 12-week observation period. Complete questionnaires assessing treatment adherence and quality of life. Participate in follow-up visits at 4, 8, and 12 weeks; the 4- and 8-week visits will be conducted remotely, while the enrollment and 12-week visits will be conducted at the study site.

Adapting a Stress Management Intervention to Reduce Cardiovascular Disease Risk

Women living with HIV have 2-4x higher risk for cardiovascular disease compared to women without HIV, with women living with HIV in the Southern US being particularly at risk. While an increased prevalence of traditional risk factors (e.g., hypertension, diabetes, and obesity) partially explain this risk, evidence suggests that increased exposure to structural and social stressors (e.g., poverty, discrimination, and stigma) among women living with HIV in the South negatively contribute to cardiovascular disease disparities through their impact on stress. The Stress Management and Resiliency Training (SMART) program is an effective, evidence-based intervention proven to improve resiliency to environmental stressors and reduce the physiologic responses to stress which contribute to cardiovascular disease. While the SMART program has demonstrated efficacy in a wide range of populations and settings, it has not been designed for or tested among women living with HIV in the South, where unique cultural and faith-based context may diminish the uptake and value of the intervention to mitigate cardiovascular disease risk. The purpose of this study is to adapt the evidence-based SMART program in consideration of the needs and contexts of women living with HIV in the Southern US and pilot the adapted intervention to establish the feasibility, acceptability, and preliminary impact of the adapted intervention to reduce stress and mitigate cardiovascular disease risk among this population.

The HELlenic Thoracic Society Initiative for CΟPD and CVD

COPD is one of the most common respiratory diseases in Greece, and maybe more than half a million Greek citizens suffer both from COPD and CVD, however their characteristics and management remain unknown. HELICOPD is a national, multicenter, prospective, non-interventional study designed to contribute to better understanding and depicting the demographic and clinical characteristics of this population, the COPD- and CVD-related adverse events in a two-years period, their quality of life and the healthcare resources use. The study is initiated and coordinated by the Hellenic Thoracic Society.

Implementing Improved Blood Pressure Measurement in General Practice: A Multisite Implementation Trial Using Automated Office Blood Pressure (AOBP)

The goal of this clinical trial is to evaluate whether implementation of guideline-recommended Automated Office Blood Pressure (AOBP) measurement in Australian general practice clinics improves hypertension control among adults aged 18 years and older who are eligible for blood pressure assessment as part of routine clinical care. The study will also evaluate the implementation, sustainability, and health economic impact of AOBP in real-world primary care settings. The main questions it aims to answer are: * Does implementation of AOBP increase the proportion of patients with treated and controlled hypertension compared with the pre-implementation period? * Can AOBP be successfully adopted, implemented, integrated into routine general practice workflows, and maintained over time? Researchers will compare outcomes following implementation of AOBP with routinely collected clinical data from the period before implementation. Participants will: * Provide informed consent and have their AOBP measurements performed during routine general practice visits. * Consent to the collection of AOBP measurement and relevant clinical information from their medical records for study evaluation. * Continue to receive usual clinical care from their general practitioner. General practice staff will receive AOBP training, perform AOBP measurements, and participate in implementation evaluation activities.

Cardiovascular Health and Nursing Interventions in 6th Grade Middle School Children

Interventions that can improve cardiovascular health behaviors in children are of critical importance for reducing the burden of cardiovascular disease in the future. The research will be conducted to evaluate the effectiveness of nursing interventions aimed at improving heart health in children. The study employs a pre-test post-test control group experimental design. The sample of the study consists of a total of 100 students, with 50 in the experimental group and 50 in the control group. The research will be conducted with students from two middle schools selected through simple random sampling method from Mamak district, Ankara province. Socio-demographic Data Collection Form and Cardiovascular Health Behavior Scale for Children will be used during the data collection process. A 5-week educational plan aimed at improving cardiovascular health behaviors will be implemented for the experimental group, while no intervention will be made for the control group. Research data will be analyzed using Statistical Package for Social Sciences (SPSS) 25.0 program. Continuous variables will be reported using mean (x̅) and standard deviation (SD), while number (n) and percentage (%) will be used for categorical variables. All tests will consider statistical significance at the level of p \< 0.05. For the study to be conducted, ethical approval will be obtained from the Ankara University Rectorate Ethics Committee, institutional permission will be obtained from the Ankara Provincial Directorate of National Education, and verbal consent from the included students and written consent from their parents will be obtained.

Randomized Cross-Over Comparison of Medium Cut-Off and High-Flux Hemodialysis Membranes

Patients receiving maintenance hemodialysis are at increased risk of cardiovascular disease, chronic inflammation, endothelial dysfunction, and impaired quality of life. Medium cut-Off (MCO) hemodialysis membranes have been developed to enhance the removal of middle-molecular-weight uremic toxins compared with conventional high-flux membranes, which may improve inflammatory status and cardiovascular health. The aim of this study is to compare the effects of MCO and high-flux hemodialysis membranes on inflammatory biomarkers and cardiovascular function in adult patients receiving maintenance hemodialysis. The primary outcomes are changes in serum interleukin-6 (IL-6) and vascular cell adhesion molecule-1 (VCAM-1) levels. Secondary outcomes include arterial stiffness assessed by pulse wave velocity (PWV), body composition assessed by Body Composition Monitor (BCM), handgrip strength, and patient-reported outcomes including quality of life, pruritus, and pain scores. This is a prospective, randomized, open-label, two-sequence, two-period crossover study conducted at Gazi University Faculty of Medicine. Thirty adult hemodialysis patients will be randomized to one of two treatment sequences. Participants in Sequence A will receive MCO dialysis membranes for the first 3 months followed by high-flux membranes for the next 3 months. Participants in Sequence B will receive high-flux membranes for the first 3 months followed by MCO membranes for the next 3 months. Blood samples and clinical assessments will be performed at baseline, month 3, and month 6. The study is expected to provide evidence regarding the effects of different dialysis membrane technologies on inflammation and cardiovascular health and may contribute to optimizing membrane selection in routine hemodialysis practice.

VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation (TRIVITA Pivotal Trial)

Pivotal trial to evaluate the safety and clinical efficacy of the VDyne System for the treatment of symptomatic severe or greater tricuspid regurgitation.

Prebiotic Inulin for Late-Reproductive Individuals

This study aims to evaluate the effects of 2 weeks of inulin supplementation in perimenopausal women with overweight or obesity. The primary questions this study seeks to answer are: 1. Does 2 weeks of inulin supplementation alter the gut and vaginal estrobolome compared with placebo? 2. Does 2 weeks of inulin supplementation affect cardiovascular health compared with placebo? 3. Does 2 weeks of inulin supplementation affect skeletal muscle health compared with placebo? Researchers will compare inulin with a placebo (a similar-looking supplement that does not contain inulin) to determine whether inulin influences gut and vaginal microbial function, cardiovascular health, and skeletal muscle health during the perimenopausal transition. Participants will: * Take either inulin or a placebo for 2 weeks, followed by a 2- to 4-week washout period, and then switch to the other supplement for an additional 2 weeks. * Attend 8 study visits over approximately 12 to 16 weeks for assessments and sample collection. * Complete weekly phone calls to monitor symptoms, supplement adherence, and dietary intake. * Wear a Fitbit device throughout the study to monitor physical activity.

Health for Hungary (H4H) - Longitudinal Collection of Blood Samples and Corresponding Data

The Health for Hungary (H4H) study collects blood samples and corresponding health data to investigate healthy aging and health-to-disease transitions in middle-aged and elderly participants. Indications Studied: Apparently healthy, symptom-free participants are enrolled and followed up to study the onset of new-onset diseases with special emphasis on non-communicable diseases (NCDs). Study Design: Single-country, multicenter, prospective, longitudinal survey. Objectives: The study aims to establish reference ranges of blood parameters using routine clinical blood tests and high-information-content methods, including proteomics, metabolomics and the so-called infrared molecular fingerprinting. The study also aims to identify novel biomarkers of major non-communicable diseases, including atherosclerotic cardiovascular disease, cancer, diabetes and chronic respiratory disease.

Evaluate the Value of Modified Shock Index in Predicting the Incidence of Cardiovascular Events After Non-cardiac Surgery in Cardiac Patients

The objective of this study is to evaluate the efficacy of the modified shock index (MSI) in predicting the incidence of postoperative cardiovascular events (PCEs) in patients with pre-existing cardiac disease undergoing non-cardiac surgery. A retrospective analysis was performed on the clinical data of patients who underwent gastric, colorectal, and hepatobiliary surgeries at Union Hospital Affiliated to Fujian Medical University between January 2020 and December 2025. Baseline characteristics, intraoperative vital signs, occurrence of postoperative cardiac complications, and total postoperative hospital stay were reviewed and summarized to assess the predictive performance of the MSI for PCEs in this patient population.

Colchicine to Reduce Coronary Artery Inflammation in People With HIV

The purpose of this study is to evaluate whether colchicine can reduce coronary artery inflammation in people living with HIV and high cardiovascular risk. Participants will be randomized 1:1 to receive either colchicine or placebo for 96 weeks in a double-blind, multicenter clinical trial. Neither participants nor researchers will know which treatment is assigned during the study. The primary endpoint is the change in coronary artery inflammation measured by coronary computed tomography angiography (CCTA) after 96 weeks.

The Effects of a 6-week Pre-operative Administration of a Microbiome Modulator "WellBiome" Versus Placebo on Cardiac Surgical Outcomes and NHS Cost Savings.

More than 7.4 million people in the UK are currently waiting for surgery. Behind that number are real people-patients preparing mentally and physically for procedures ranging from joint replacements to major heart and abdominal operations. This research forms part of a broader strategy known as prehabilitation - preparing the body before surgery to improve outcomes afterward. For patients waiting for surgery, it represents a shift from passive waiting to active preparation. Heart surgery for bypass or valve replacements results in inevitable yet controlled trauma. It increases inflammation, stress hormones and immune system demand. The body then has to repair itself - quickly and efficiently. And here's the surprising part. Inside your gut live trillions of bacteria - called your gut microbiome. These bacteria help regulate inflammation, strengthen your immune system and protect against infection. This randomised clinical trial is investigating a fascinating question: Can improving your gut microbiome through consumption of fibre before surgery help you recover faster, reduce time in ICU, shorten hospital stays, and lower complication rates? The placebo controlled trial will randomise 80 patients following eligibiilty checks to either 5g of prebiotic fibre/300mg of magnesium (WellBiome) OR 5g of maltodextrin for a period of 6-8 weeks prior to surgery. Patient will provide blood, urine and faecal samples at baseline and upon admission for surgery, and two further blood samples at day 3 and 6 post operatively. Following surgery, patient outcomes will be assessed and compared between the experimental group (prebiotic fibre/magnesium) and placebo group (maltodextrin). The investigators are focussing on the time spent in the intensive care unit, complications and overall hospital stay. By documenting and quantifying these the investigators can calculate the costs and any savings between the groups.

European Study of the BrioVAD Heart Pump for Advanced Heart Failure

This clinical investigation evaluates the safety and clinical performance of the BrioVAD Left Ventricular Assist System in patients with advanced, refractory left ventricular heart failure who require mechanical circulatory support.

Royal Jelly as a Strategy to Modulate Inflammation and Oxidative Stress in Patients With Systemic Arterial Hypertension

The study aims to evaluate the effect of the royal jelly on inflammation and oxidative stress in participants with systemic arterial hypertension. A longitudinal double-blind randomized clinical trial will be carried out, involving hypertensive participants for two months.