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Showing 1-20 of 1,087 trials
NCT04777383
Many acute and chronical medical conditions, such as, shock, sepsis, diabetes, hypertonia, and cardiovascular disease are associated with a perturbated or lost ability of regulating the diameter of the blood vessels. These changes in regulatory function can be seen especially in the smaller vessels in the body. It is therefore clinically relevant to develop investigation models that can detect and quantify such changes at an early stage. Historically, basic vascular function was investigated by mounting a section of a blood vessel on a tension sensor, submerging it in a temperature controlled and buffered solution to which vasoactive substances were added. This in vitro model has contributed substantially to our current knowledge of vascular pharmacology and function. However, using this method means that the vessel is removed from its natural environment and, hence no longer influenced by systemic or local mediators for controlling vessel diameter. The present study aims to investigate the local changes in blood flow and concentration of red blood cells of the superficial vessels in the skin of the forearm of healthy volunteers in response to various vasoactive substances. The purpose is to better understand how the regulation of diameter works in and to find a model that can give an early warning to when it does not function optimally. The vasoactive substances will be delivered through the skin to the vascular bed by a non-invasive method called iontophoresis. An electrode chamber containing a solution of the substance to be studied is placed on the subject's skin by double adhesive tape. The chamber comes with a transparent lid that prevents leakage and enables supervision of the effect on the underlying vasculature. When a voltage is applied the charged drug molecules begin to move through the skin and interact with the vessels. In the present study, a total electrical dose of 12 millicoulomb (mC) is going to be used (600 seconds x 0.02 milliampere). The effect of the applied drug is measured using two non-contact, optical measurement techniques. A better understanding of the pharmacology and regulation of blood vessels may lead to the developement of techniques that allow earlier detection of perturbations in vessel regulation and the onset of preventive medical treatment.
NCT07547098
This is a single-center observational registry study aiming to establish a structured clinical and multimodal imaging database for cardiovascular-kidney-metabolic (CKM) populations and to support lifecycle follow-up and outcome management. Adult patients aged 18-80 years with cardiovascular, kidney, and/or metabolic diseases or key data for CKM phenotyping will be enrolled at the First Affiliated Hospital of Fujian Medical University. The study integrates retrospective data entry and prospective follow-up, including clinical records, laboratory tests, medications, electrocardiography, echocardiography, vascular function assessment, carotid and abdominal ultrasound, bone density, coronary CTA and post-processing data. The primary outcome is the first occurrence of a cardiorenal composite endpoint. Participants will be followed for up to 5 years through active annual follow-up and passive monthly data updates to support risk stratification, real-world evidence generation, and CKM management pathway optimization.
NCT07543731
This study aims to evaluate the long-term adherence and persistence to inclisiran and anti-proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies (mAbs) in real-world clinical practice.
NCT03898206
The purpose of this study is to examine whether breaking up prolonged sitting with short regular bouts of walking can reduce blood sugar and cholesterol levels after eating, which are risk markers for Type 2 diabetes and heart disease. This study will compare these responses in normal-weight versus overweight/obese South Asian adults.
NCT05841784
This study was designed using the Multiphase Optimization Strategy (MOST) framework to determine whether two supplemental components increase the efficacy of a mindfulness-based cognitive therapy program delivered via telephone (MBCT-T) for psychological distress. Specifically, this study will test mindfulness booster sessions to follow a standard 8-week MBCT-T intervention, as well as website support in patients with heart disease and/or heart disease risk factors.
NCT05516277
This pilot pre-post trial will address a gap in knowledge related to addressing modifiable risk factors for cardiometabolic disease through treating residual insomnia, sleep difficulties that remain after successful treatment of another condition, in the context of PTSD in understudied older adults. This study provides a non-medication treatment for PTSD called Cognitive Processing Therapy (CPT) followed by a non-medication sleep education and treatment program (Cognitive Behavioral Therapy for Insomnia, CBT-I) for sleep problems that remain after completing PTSD treatment in older adults with PTSD. The aims of this project are to evaluate 1) the added benefits of treating residual insomnia on sleep and PTSD symptoms; 2) the added benefits of treating residual insomnia following CPT on cardiometabolic risk biomarkers and quality of life; and 3) the durability of the sleep, PTSD, cardiometabolic and quality of life benefits of treating residual insomnia following CPT at 6-month follow-up in older adults with PTSD.
NCT06515912
The goal of this clinical trial is to examine the effect of the ketogenic diet over four weeks on blood lipid levels and risk factors for heart disease in adults with a healthy BMI compared to adults with a body mass index (BMI) in the range for obesity. The main questions it aims to answer are: * Does the ketogenic diet cause larger increases in "bad cholesterol" (low density lipoprotein-cholesterol) in adults with a healthy BMI compared to adults with BMI in the range for obesity? * Does the ketogenic diet cause larger decreases in vascular health in adults with a healthy BMI compared to adults with BMI in the range for obesity? Participants will: * Consume all of the study food provided and avoid intake of non-study foods during the 28-day diet period * Visit the metabolic kitchen daily (Monday-Friday) to pick up meals * Attend 5 fasting visits at the Clinical Research Center for testing
NCT03626688
Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.
NCT04971720
Obese individuals have a higher prevalence of nocturnal hypertension and non-dipping blood pressure (BP). These conditions are associated with an increased risk of cardiovascular (CV) events and death. Natriuretic Peptides (NPs) are hormones produced by the heart which directly regulate BP by causing dilation of blood vessels and by removing sodium and water from the body. NPs have a 24-hour day-night rhythm and this controls the day-night rhythm of BP as well. The NP-BP rhythm relationship is broken down in obese individuals. Obese individuals also have lower circulating NP levels. Lower circulating levels of NPs and elevated renin hormone (a part of the Renin-Angiotensin-Aldosterone System \[RAAS\]) at nighttime may contribute to the high nocturnal blood pressure in obese individuals which puts them at a higher risk of developing CV events. This current study seeks to determine the biological implications of chronopharmacology for synchronizing NP-RAAS-based blood pressure therapy with the physiological diurnal rhythms to restore the normal diurnal rhythm of blood pressure in obese individuals.
NCT05869604
There are close to 700,000 survivors of adolescent and young adult (AYA) cancer (aged 15 to 39 at diagnosis) in the US. Survivorship for AYAs is often complicated by long-term and late-effects. Cardiovascular disease (CVD), in particular, is a leading cause of death for cancer survivors and is a growing public health concern for survivors diagnosed as AYAs. Risk of CVD may be associated with treatment exposures and may be potentiated by weight gain and poor health behaviors. Healthy eating and physical activity are key behaviors for weight loss and maintenance and may be protective against CVD risk, yet few AYA cancer survivors adhere to guidelines for healthy eating or activity. AYA survivors' abilities to engage in health behaviors (i.e., healthy eating, physical activity) necessary to manage weight may also be challenged by persistent cancer-related symptoms (i.e., pain, fatigue, psychological distress). Thus, weight gain is common. Using input from AYA cancer survivors, the investigators have adapted a behavioral weight and symptom management protocol for AYA cancer survivors with obesity to create an intervention that is responsive to AYAs' unique needs. A pilot randomized controlled trial will be conducted to examine intervention feasibility and acceptability and to examine patterns of change in outcomes including weight, body mass index, symptoms (e.g., pain, fatigue, distress) as well as other CVD risk factors, including blood pressure, cholesterol (total, HDL, LDL), HbA1c, and atherosclerotic cardiovascular disease (ASCVD) risk score.
NCT05908240
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.
NCT06392828
Management of risk factors is the primary approach to prevent cardiovascular disease (CVD). In this regard the accurate scoring of disease risk is fundamental. Non-alcoholic fatty liver disease (NAFLD) has emerged recently as a potential mediator of CVD onset and progression. The hypothesis is that NAFLD can be a predictive CVD risk factor, independent of other classical and well-known risk factors. Preliminary epidemiological studies suggested that the fat infiltration in the liver mirrored the cardiometabolic status of the patient. But recent studies postulate that NAFLD could be a potential independent predictor of vascular injury. The mechanisms that link liver function and endothelial damage include modulation of adipose tissue function, lipid metabolism regulation or glycemic homeostasis, among others. But new mechanisms that could link NAFLD and ECV are emerging. The synthesis of ketone bodies in the liver is closely related to the cardiovascular system function. Ketone bodies can provide up to 50% of energy required by specific tissues. Plasma concentration of β-hydroxybutyrate is a biomarker of NAFLD. Plasma β-hydroxybutyrate and acetoacetate levels are also inversely associated with endothelial injury. Other biomarkers on endothelial damage like von Willebrand factor, ICAM, VCAM or coagulation factors (Factor VIII) can be used to stratify patients according to the risk of CVD. The improvement in the sensitivity, specificity and accuracy of scores such as FLI, HIS and FIB-4 and non-invasive techniques such as elastography allow the study of the relationship between liver disease and other comorbidities. The aim is to evaluate the potential of NAFLD to stratify patients according to the risk of CVD and to investigate the molecular mechanisms linking NAFLD and CVD.
NCT07491315
Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS) is a disease characterized by persistent and unexplained fatigue associated with diffuse pain, sleep disorders, neurocognitive and autonomic symptoms, musculoskeletal manifestations and digestive symptoms. A central feature of this disease is post-exertional symptom exacerbation, also referred to as post-exertional malaise, defined as the worsening or the appearance of symptoms after physical or mental exertion, sometimes even minimal. Several studies have described post-exertional malaise in populations of patients with ME/CFS following a standardized exercise test performed over one or two consecutive days. These studies confirmed the presence of post-exertional malaise in ME/CFS patients compared with healthy controls or patients with multiple sclerosis. However, no data are available evaluating the impact of an exercise test on symptoms in patients referred to cardiology for this examination. Patients with cardiac diseases may also present symptoms such as fatigue, dyspnea or exercise intolerance. This study aims to compare post-exertional symptoms in two populations: patients with ME/CFS and patients with cardiac diseases undergoing an exercise test as part of routine clinical evaluation. The study also aims to measure variations in muscle oxyhemoglobin and deoxyhemoglobin concentrations before, during and after exercise using Near Infrared Spectroscopy (NIRS).
NCT04645875
The purpose of this study is to investigate the effects of substituting sitting under free-living conditions in South Asian adults with overweight and obesity on continuous glucose profiles.
NCT05096338
This is an observational study for patients with prostate cancer that will be treated with Androgen Deprivation Therapy. The study will help the investigators learn more about how these medications affect the heart and how those effects relate to patients' medical history and social determinants of health (such as race, gender identity, education, occupation, access to health services and economic resources). Patients on this study will have echocardiograms, blood draws, and answer questions about their symptoms and activity level. Patients will be followed on this study for up to 5 years.
NCT07256249
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.
NCT07487363
This fictional study is an example of a ClinicalTrials.gov-style record. It describes a Phase 1/2 trial evaluating the safety and tolerability of TB-500 (a 17-23 fragment of thymosin beta 4) versus placebo in adults with stable atherosclerotic cardiovascular disease (ASCVD). Exploratory endpoints assess vascular function and inflammation biomarkers
NCT07483801
What is the research question? Semaglutide and tirzepatide cause weight loss and blood pressure reduction. However, weight loss only partially explains the blood pressure reduction. Based on previous studies, there might be direct effects in the cardiovascular system. In forearm blood flow studies, semaglutide and tirzepatide will be infused into the brachial artery to investigate their effects on the function of blood vessels. In systemic studies, semaglutide and tirzepatide will be infused into systemic circulation to investigate their effects on heart and blood vessels. There are three different populations being looked at for this study: participants with normal weight and normal blood pressure, participants with obesity and normal blood pressure, and participants with obesity and high blood pressure. There are six sub-studies each with different visit schedules. The minimum participant study duration (including follow-up phone call) would be 2 days, while the maximum participant study duration would be approximately 2 - 2.5 months. The overall study duration is expected to be approximately 18 months.
NCT07483502
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.
NCT02000895
Infants born preterm and of low birth weight are known to be at increased risk for early onset of cardiovascular and renal disease in adult life. This has been related to low nephron mass due to inadequate or early termination of glomerulogenesis in utero and during the perinatal period. Risks for subsequent development of hypertension and kidney disease include proteinuria, excessive weight gain during early life with insulin resistance and supplemental high calorie feedings. The long-term goal is for early diagnosis of those infants who are at risk for future development of hypertension and kidney disease so that the investigators might intervene to potentially avert progression to adult disease. The objective of this clinical trial is to acquire data on the natural history of neonatal kidney function and size in infants born preterm during the first 2 years of life. This will be done through the use of standard serum and urine markers as well as non-invasive ultrasound technology. The central hypothesis of this clinical trial is that a subgroup of patients born preterm and of low birth weight will demonstrate early markers of kidney injury including elevated serum cystatin C, proteinuria and low kidney size. This hypothesis has been formulated on the basis of preliminary data from our group studying this question retrospectively in older children born prematurely who have developed overt kidney disease. The rationale for the proposed research is to develop early serum and demographic markers of pre-clinical kidney disease so that early intervention can occur. The proposed clinical trial is innovative because it will investigate the risk factors for kidney dysfunction at a pre-clinical stage with the idea of gaining more knowledge regarding therapeutic interventions. In addition, the study will assess serum cystatin C as a surrogate test for glomerular filtration rate which could indicate worsening kidney function at an earlier stage than serum creatinine. The proposed research is significant because it is expected to identify at-risk patients for future renal impairment and to prospectively monitor the persistence of proteinuria and its effect on kidney function in the short term.