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Cardiovascular Risk Factor clinical trials

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NCT ID: NCT06225544 Not yet recruiting - Clinical trials for Cardiovascular Disease

Lumasiran in Hyperoxalaemic Patients on Haemodialysis

LHOxH
Start date: March 1, 2024
Phase: Phase 2
Study type: Interventional

This study will look at how well a drug that reduced the amount of oxalate in the body works in patients that have kidney disease and need dialysis treatment. People with kidney disease often have higher levels of oxalate in the blood. People with kidney disease are also at higher risk of having heart attacks, heart disease and strokes (these are called cardiovascular diseases). It is thought that high oxalate levels may increase the risk of these diseases. So we would like to study if this medicine can lower the amount of oxalate in the blood of dialysis patients and see if there is any change in the health of their heart. This medicine is already used for people who have high oxalate levels because of a genetic cause and has been used safely for patients on dialysis. The study will put the participants randomly into either the group getting the study medicine or the group getting a placebo (this will be a solution of saline water). Neither participants not the doctors will know whether the drug or placebo is given until after the end of the study. At the start of the study we will ask all the participants to have an echocardiogram (an ultrasound of the heart) and again 6 months later at the end of the study. We will also take blood tests once a month when the participants come for dialysis.

NCT ID: NCT05735457 Not yet recruiting - Clinical trials for Cardiovascular Risk Factor

A Short, Animated Storytelling Video to Increase Knowledge About Sodium Intake as a Cardiovascular Risk Factor

Start date: June 1, 2023
Phase: N/A
Study type: Interventional

This study will evaluate the effect of a short, animated storytelling intervention video on sodium intake as a major risk factor for cardiovascular disease on immediate and medium-term retention of knowledge about the risks of cardiovascular diesaes due to increased sodium intake. We will also measure voluntary engagement with the content of the short, animated storytelling intervention video on positive psychological capital. In this 4-armed, parallel, randomized controlled trial, 10,000 adult, US participants will be randomly assigned to (1) a short, animated storytelling intervention video on sodium as a cardiovascular disease risk factor followed by surveys assessing the facts om sodium and cardiovascular disease conveyed in the video (2) the surveys only, (3) an attention placebo control video followed by the before mentioned surveys, and (4) an arm that is exposed to neither the video nor the surveys. Two weeks later, participants in all four arms will complete all of the surveys. The primary outcome is knowledge about the cardiovascular disease risk associated with increased sodium intake (immediate and medium-term). The major scondary outcome is the extent of voluntary engagement with the short, animated storytelling video content.

NCT ID: NCT04861545 Not yet recruiting - Clinical trials for Cardiovascular Risk Factor

Meta-analyses of Soy Protein and Its Food Sources for Cholesterol Reduction

Start date: May 1, 2021
Phase:
Study type: Observational

Although soy protein has approved health claims in Canada and the US, and is recognized by major cardiovascular clinical practice guidelines for the reduction of cholesterol and risk of coronary heart disease (CHD), these claims are based almost exclusively on evidence from foods containing isolated soy protein (ISP). The role of other non-ISP food sources of soy protein (e.g Tofu, tempeh, edamame) in these effects is unclear. The role of food form and matrix (e.g soy beverage versus meat analogue) on the effects of ISP is also unclear. As national dietary guidelines and clinical practice guidelines for nutrition therapy shift from a focus on single nutrients to a focus on foods and dietary patterns, it is important to understand whether non-ISP food sources of soy protein and ISP food sources with different food matrices produce the same reductions in LDL-cholesterol and CHD risk. To strengthen the evidence-base for health claims and guidelines development, the investigators will conduct a systematic review and meta-analysis of randomized controlled trials of the effect of ISP and non-ISP food sources of soy protein on stablished lipid targets in individuals with and without dyslipidemia.

NCT ID: NCT04688684 Not yet recruiting - Clinical trials for Overweight and Obesity

The Emirates Heart Health Project: A Family-based Diet and Exercise Intervention in Obese and Overweight Patients

EHHP
Start date: June 1, 2022
Phase: N/A
Study type: Interventional

Data from Abu Dhabi's Department of Health document that the leading cause of death among the population of the emirate of Abu Dhabi is cardiovascular disease (CVD). Even with significant investment of time and resources, this has not improved over time. CVD was the cause of death in over 39% of deaths occurring in patients above 45 years of age. In those older than 60 years of age, CVD causes more deaths than cancer, respiratory diseases, and infectious disease combined. Eating an unhealthy diet is the leading risk factor for CVD-related deaths and one study estimated that the current diet accounted for 72% of CVD-related deaths in the United Arab Emirates (UAE). Interestingly, the limited intake of whole grains was associated with 22% of CVD-related deaths in the UAE. Other risk factors include consumption of processed meat, red meat, and sugar sweetened beverages. Despite recognition of what constitutes healthy diet and exercise practices by survey participants, barriers exist to lifestyle change. In one UAE study of patients with type 2 diabetes, only 3% of the 390 individuals surveyed met numerous guidelines' weekly recommendations for 150 minutes of moderate intensity aerobic activity or 90 minutes of vigorous aerobic activity. The most common reasons given in that study for not exercising included cultural reasons (29.2%), "exercise is boring" (20.3%), and lack of family support (4.1%). Widespread availability and access to outpatient dieticians has not lowered rates of obesity, overweight, and cardiovascular disease risk factors. To the investigators' knowledge, this would be the first study investigating the effect of a package of family based lifestyle interventions guided by a health coach. This package of interventions would be supported by technology such as a smartphone application to record dietary intake and the use of wearable fitness trackers to track physical activity. The nationals of the UAE (called Emiratis),have retained traditional cultural values, including strong ties to extended family, which may lead to better adherence to family based rather than individual appointments and interventions, which could lower CVD risk.

NCT ID: NCT04531267 Not yet recruiting - Hypertension Clinical Trials

Ratio of Dietary Calcium to Magnesium on Cardiovascular Risk

Start date: January 2021
Phase: N/A
Study type: Interventional

Although the epidemiological studies indicate how magnesium and calcium may interact to affect cardiovascular risk, current clinical trials have not elucidated the associations, particularly among hypertensive patients. To address the research gap, we have to examine how magnesium may influence cardiovascular profile of hypertensive patients via the modification of calcium homeostasis. Meanwhile, large-scale cohorts in China suggested keeping dietary calcium: magnesium ratio within 2.3 can reduce the risk of cardiovascular mortality. The results indicate the potential for individualized nutrition. This study will recruit uncontrolled hypertensive patients taking single drug and investigate whether calcium-magnesium combined supplements help to control their blood pressure. In standardized manner, subjects in the intervention group and the control group (each with 21 subjects) will be assessed for their dietary calcium and magnesium intake in the previous three months, so that researchers can provide calcium and/or magnesium supplements to maintain a calcium/magnesium ratio as 2.3. The effect of supplementation will be evaluated by the blood pressure changes in the 12th week of intervention.

NCT ID: NCT04531124 Not yet recruiting - Hypertension Clinical Trials

Cardiovascular and Renal Outcomes of Integrated Management of Blood Pressure and Other Cardiometabolic Risks in Hypertensives

Start date: September 1, 2020
Phase:
Study type: Observational

this clinical trial is designed to study the cardiovascular and renal outcomes of hypertensives after an integrated management of blood pressure and other cardiometabolic risks. it is a multicenter prospective cohort study.

NCT ID: NCT04303546 Not yet recruiting - Clinical trials for Cardiovascular Diseases

VOPITB a New Devices to Determine Peripheral Arterial Stiffness: Validation Study

Start date: March 8, 2020
Phase:
Study type: Observational [Patient Registry]

Our group has developed a device called "Velocidad Onda de Pulso Indice Tobillo Brazo (VOPITB)" . In this device the oscillometric method is used for easily and accurately measure the pulse wave velocity PWV in the arms and legs separately, allowing new arterial stiffness indices to be studied (sum, difference, ratio, baPWV and CAVI). The aim of our study will be to validate the PWV measures by VOPITB with other references devices that measures arterial stiffness. Moreover we will perform a clinical study to assess the clinical utility of VOPITB.

NCT ID: NCT04064281 Not yet recruiting - Hypertension Clinical Trials

The Healthy Cantonese Diet on Cardiometabolic Syndrome

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

The DASH diet (Dietary Approaches to Stop Hypertension) have been proven to lower risk of cardiovascular diseases. But the DASH diet is inconsistent with Chinese dietary pattern. In this study, based on the typical Cantonese diet, the healthy Cantonese diet is developed according to the DASH diet and the balanced dietary pattern of the Chinese Dietary Guidelines 2016. The randomized control trial is designed to investigate whether the healthy Cantonese diet has benefit to blood pressure, blood lipid, blood glucose and other cardiometabolic biomarkers among adults with cardiometabolic syndrome in Guangdong, China.

NCT ID: NCT03869112 Not yet recruiting - Clinical trials for Cardiovascular Diseases

Physical Activity Intervention and Cardiovascular Risk Markers in COPD

PARC
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

The Aim of this study is to examine the feasibility of a future trial comparing the impact of a physical activity intervention and a standard pulmonary rehabilitation programme upon cardiovascular risk and symptoms in COPD. The study involved three groups which are physical activity group, pulmonary rehabilitation group and usual care. The physical activity group and the pulmonary rehabilitation group will complete six-weeks of intervention. The pulmonary rehabilitation group will participate in a standard rehabilitation programme of supervised exercise and education sessions. Physical activity group will be involved in a programme that aims to increase their physical activity level with an increasing step count. Usual care group will be monitored for six-weeks. Before and after interventions measures will be taken including exercise capacity, body composition, blood tests, arterial stiffness, questionnaires assessing health quality of life, anxiety and depression, symptoms, cardiovascular disease risk. The investigators will also have a sub-group study. The subgroup study will have two arms interventions which are pulmonary rehabilitation group and physical activity group. The investigators will recruit 10 participants for each group from the main groups' population (no usual care group). Additional before and after measures will be taken for sub-group study and that includes Magnetic resonance imaging (MRI) scanning for adipose visceral tissue and postprandial lipaemic response test. It is hypothesised that exercise and physical activity level can reduce cardiovascular disease risk with COPD patients, but the relative impact of both interventions need to be explored.

NCT ID: NCT03622957 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

Association Between Phthalates Exposure and Renal Function Impairment in TYpe 2 Diabetes

PURITY-2
Start date: August 10, 2018
Phase:
Study type: Observational

The global incidence of diabetic nephropathy (DN) is increasing, with no appreciable reduction in the percent of patients progressing toward end stage renal disease (ESRD) and dialysis (Tuttle et al, 2014, Winocour et al, 2018). Therefore, identification of modifiable risk factors and early biomarkers of progressive decline in kidney function is an urgent clinical need. Phthalates are environmental and dietary contaminants with a various array of use that are identified in many consumer and industrial products; among them, di-(2-ethylhexyl) phthalate (DEHP) and its metabolites (mono 2-ethylhexyl phthalate (MEHP), 5OH-MEHP (MEHHP) and 5oxo-MEHP (MEOHP)) are widely used (Kato et al 2004, Braun et al, 2013). They partially distribute to the human tissues and their urinary and serum levels are directly related; therefore, urinary concentration of phthalates is commonly used as proxy of their exposure in humans (Kato et al 2004). While the association between phthalates exposure and development of T2D is currently being explored (Dong et al 2017, Dales et al, 2018), little is known about their role in DN. Recent observations show that DEHP and its metabolites are associated with a higher prevalence of low-grade albuminuria and in children exposed to higher phthalates concentrations (Trasande et al, 2014, Wu et al, 2018), however such association has yet to be verified in adults. The environmental ubiquity of the phthalates enhances the importance of investigating the potential relation between their exposure and different degrees of renal function. (Kato et al 2004, Kataria et al, 2015). Given this premise, the investigators will explore this potential association in a population of subjects with T2D consecutively referring to the outpatient diabetes clinic in Santa Chiara Hospital, Pisa, enrolled on a volunteer basis. During their routine visit at Santa Chiara Hospital outpatient diabetes clinic participants will provide the results of blood tests prescribed as per standard clinical practice along with a first morning, overnight fasting, urine sample collected in a phthalates-free container. The investigators will record the participants' clinical history, physical examination and anthropometric measurements, will measure their renal function, evaluated by eGFR (calculated with the CDK-EPI formula), albumin excretion, fasting glucose, HbA1c%, and the exposure to phthalates, assessed by total concentrations of MEHP, MEOHP, MEHHP and adjusted for urinary creatinine. In this way, the investigators aim to point out the relationship of urinary phthalates with higher degrees of albuminuria and/or lower eGFR after adjustment for all potential confounders, including therapies.