Cardiovascular (CV) Risk

The goal of this prospective study is to gain insight into the endophenotypic variation in OSA, with a focus on the underlying pathophysiological traits and the cardiovascular alterations associated with the condition. To capture the variability in OSA endophenotypes, novel metrics that extend beyond the AHI will be considered, with particular attention to the sleep-apnea-specific hypoxic burden, the sleep-apnea-specific heart rate response, and pulse wave amplitude drops (PWADs). Since the impact of treatment on cardiovascular parameters remains an important point of interest, the effects of different treatment modalities on cardiovascular changes will be investigated, including continuous positive airway pressure (CPAP), mandibular advancement devices (MADs), and hypoglossal nerve stimulation.

Obesity is one of the most common health conditions among autistic young people and its prevalence rises at faster rates for autistic-relative to non-autistic-individuals. This places them at heightened risk for cardiovascular disease (CVD) and mortality before they enter adulthood. Studies have identified three key contributing factors to CVD outcomes in autistic individuals: unhealthy lifestyle behaviors, Adverse Childhood Experiences (ACEs), and chronic stress. This study will explore the effectiveness of two CVD-focused primary care interventions for autistic individuals (ages 9-26): (1) lifestyle medicine consultations tailored towards supporting health-promoting behaviors; and (2) a Cognitive Behavioral Therapy (CBT) intervention tailored towards addressing chronic stress that contributes to excess weight and maladaptive eating behaviors and results in obesity and CVD. Participants and their caregivers will be randomly placed into either the Lifestyle Medicine Group, CBT Group, or combined Lifestyle Medicine with CBT Group. Participants will respond to questionnaires and surveys measuring lifestyle habits, stress, and psychological risk factors at their first visit, 6-month visit, and 3 months post-intervention visit. Over the course of 6 months, participants will attend virtual sessions (up to three times a month) in accordance with their intervention group.

Background: Heart disease is a leading cause of death in the United States. Healthy diet and exercise improve heart health. Some features of where a person lives can lead to stress and decrease chances for exercise. Researchers want to see how these factors may increase the risk of heart disease in women. Objective: To see if there are differences in stress levels between women who live in different parts of Washington, DC. Also, to see how these women use their neighborhoods for exercise. Eligibility: Healthy white or black females ages 19-45 who live in Washington, DC, who have access to a smartphone Design: Participants may stay at the NIH Clinical Center overnight for a 2-day visit. Visit 1 will include: Physical exam Blood tests Electrocardiogram: Electrodes on the participant s skin will measure heart activity. PET/CT scan: Participants will get an injection. They will lie in a machine that takes pictures of the body. Surveys Body size measurements Nutrition consultation Blood vessel tests: This is measured with blood pressure cuffs, a device placed on the participant s fingertip, and a probe placed on the participant s neck. Resting Energy Expenditure: Participants will breathe under a clear hood for 45 minutes. Participants will be followed for about 2 weeks. They will wear a device on the wrist and carry a GPS device. Through a mobile app, they will answer short daily surveys on stress and exercise. Visit 2- Device return Nutritional consultation

The purpose of this research study is to determine whether the use of in-home air filtration to reduce exposure to air pollution benefits health.

Cardiovascular diseases represent one of the leading causes of morbidity and mortality worldwide. Prevention in patients at cardiovascular risk is essential to reduce the incidence of cardiovascular events and slow the progression of risk. This study aims to evaluate the effectiveness and feasibility of a cardiovascular prevention pathway delivered remotely through a digital application, comparing it with a traditional in-person care pathway.

The goal of this early-stage study is to support the heart health of home health aides, a workforce that provides care for adults at home but whose own health has been historically poor. To do this, the study will use Life's Essential 8 (LE8), a program developed by the American Heart Association (AHA) that promotes cardiovascular wellness through education and lifestyle changes. The program has been adapted specifically for home health aides and will be delivered by trained "peer coaches," who are fellow home health aides who will help guide participants through the program. The main questions the study aims to answer are: * Will the LE8 intervention, which provides cardiovascular health education and support with positive thinking, be used by home health aides and do they like it? * Does the LE8 intervention actually improve home health aides' cardiovascular health after the intervention's conclusion compared to baseline? Participants will be paired with a trained peer coach and take part in the 10-week program over the course of 6 months. The program includes support for healthy behaviors and positive thinking, with the goal of making lasting improvements in cardiovascular health.

The purpose of this study is to find out if full-fat dairy and low-fat dairy have similar effects on risk factors for heart disease and diabetes. During the study, participants will consume two types of dairy products: low-fat dairy (milk, yogurt, and cheese) and full-fat dairy (milk, yogurt, and cheese). Each type of dairy will be consumed for 6 weeks with a ≥4-week break between. Measures will be taken to evaluate blood cholesterol, blood sugar, body weight, inflammation, blood pressure, heart health and dietary intake at the beginning and end of each 6 week period.

Limiting perioperative tachycardia (aiming for a heart rate \<90 beats per minute throughout the perioperative period) using the ultra-short acting beta-blocker landiolol in patients with cardiovascular risk factors undergoing major surgery might lower the incidence of perioperative myocardial injury. Feasibility of the intervention needs to be proven prior to conduction of a larger trial.

Menopause is associated with the acceleration of many comorbidities, including cardiovascular disease. Whether HIV and menopause together increase cardiovascular disease risk is a key knowledge gap. The goal of this observational study is to address this knowledge gap by looking at the role of menopause on cardiovascular disease risk factors such as insulin resistance, hypertension, hyperlipidemia, and carotid atherosclerosis using previously collected data. The investigators will look at underlying causes for cardiovascular diseases worsening in menopausal women with HIV by looking at the role of increased inflammation in the body and whether this is altered by weight. The investigators achieve this by enrolling participants who are willing to undergo a whole body MRI.

This prospective observational cohort study aims to evaluate the association between liver fat fraction measured by ultrasound-derived fat fraction (UDFF) and cardiac functional parameters assessed by 2D and 4D HeartAI in adult patients with metabolic dysfunction-associated steatotic liver disease (MASLD). Participants will undergo baseline assessment and repeat evaluations at 6, 12, and 36 months. The study will assess the diagnostic performance of integrated UDFF-HeartAI analysis for detecting subclinical cardiac abnormalities and identify predictors of cardiovascular risk progression and major adverse cardiovascular events in patients with MASLD.

This pilot study evaluates the feasibility, acceptability, and preliminary effectiveness of Lion Hearts, a community-based, family-centered physical activity intervention designed to improve cardiovascular health among mother-child dyads. Developed through community co-design, the 12-week intervention is delivered in local CrossFit affiliates and includes twice-weekly fitness sessions incorporating functional movement, goal setting, teamwork, and health education. The study aims to assess changes in physical activity, fitness, and cardiovascular health markers, as well as family dynamics and motivation for physical activity. Participants complete baseline, mid-, post-, and 3-month follow-up assessments, including surveys, fitness testing, accelerometry, and optional lab work. Findings will inform the refinement of the intervention for future large-scale trials.

The goal of this clinical trial is to determine whether an aerobic exercise program can reduce cardiovascular risk in patients with systemic inflammation, such as those with rheumatoid arthritis and chronic kidney disease. The main questions this study aims to address are: * Does an individualized aerobic exercise program reduce cardiovascular risk, as assessed arterial stiffness and endothelial function ? * What are the effects of this exercise program on inflammation and immunosenescence? Researchers will compare an individualized aerobic exercise program with a therapeutic education program (consisting of educational phone calls only) and a control group with no intervention. Participants will: * Perform three physical activity sessions per week for six weeks (45-minute sessions at 60-80% of heart rate reserve); * Attend clinic visits at baseline, after the 6-week intervention, and at a 6-week follow-up after the intervention; * Undergo assessments including pulse wave velocity, hyperemic reactivity, and blood analyses.

The goal of this clinical trial is to learn if newly developed intervention package works to improve physical activity level among patients with intermediate cardiovascular risk factors. The main questions it aims to answer are: Does the INSPIRE-PA intervention increase the level of physical activity among participants with intermediate cardiovascular risk factors? * What changes occur in physical activity level, BMI and blood pressure following participation in the intervention? * Are there any challenges, barriers, or unintended effects experienced by participants during the intervention period? * Researchers will compare the INSPIRE-PA intervention to usual care to determine whether the empowerment-based strategy is effective in improving physical activity levels and reducing cardiovascular risk among patients attending government primary medical care Iinstitutions. Participants will: * Participate in the INSPIRE-PA program for 6 months * Attend scheduled follow-up visits at the primary medical care institution (e.g., every 2-4 weeks)for counselling, evaluation of physical activity level, and assessment of cardiovascular risk indicators * Engage in structured physical activity as recommended in the intervention package * Record their daily physical activity and any challenges or barriers in a physical activity logbook or diary * Undergo periodic measurements such as blood pressure, weight, waist circumference, and other relevant clinical assessments

The goal of this randomized four-arm clinical trial is to determine the effect of 16-week water physical exercise program in thermal water and hydroponotherapy on lipide profile in middle-aged and elderly people, with controlled health conditions. Participants will be randomizate into four arms: * Arm I: Control * Arm II: Water Physical Exercise Program (WPEP) in thermal water * Arm III: Hydropinotherapy with thermal water combined with bay leaf (L. nobilis) * Arm IV: WPEP in thermal water and hydropinotherapy with thermal water combined with bay leaf (L. nobilis) Primary outcome: 1. Lipid profile (cholesterol total, low-density lipoprotein cholesterol (c-LDL), high-density lipoprotein cholesterol (c-HDL), triglycerides) Secondary parameters: 2. Inflammatory biomarkers: interleukin-6 (IL-6), C-reactive protein (CRP) 3. Glucose metabolisc: fasting plasma glucose, insulin, Hemoglobin A1c (HbA1c) 4. Aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase, bilirubin, creatinine. 5. Anthropometric and clinical variables: weight, waist to hip ratio, body composition and bone mineral density 6. Systolic and diastolic blood pressure 7. Physical function 8. Lifestyle parameters: sleep quality, quality of life and eating habits

The aim of this prospective interventional study is to investigate the metabolic effects of consuming artificial and natural sweeteners in persons with prediabetes. Prediabetes is a condition characterized by blood sugar levels that are elevated above normal but not yet meeting the criteria for type 2 diabetes. This condition markedly increases the risk of progressing to type 2 diabetes, which in turn can lead to complications including cardiovascular diseases. Artificial sweeteners such as saccharin and sucralose, as well as natural sugar substitutes like erythritol, are increasingly used as alternatives to sugar and are recommended for individuals at cardiometabolic risk - including overweight individuals, patients with prediabetes, or diabetics - to help reduce caloric intake. Recent literature has reported possible negative associations between artificial sweeteners and blood sugar regulation in healthy subjects (1). Additionally, effects on various blood cells have been observed. For example, erythritol has been shown to alter platelet function leading to increased reactivity in healthy study participants following consumption (2). However, the impact of alternative sweeteners on metabolic processes and their effects on blood coagulation in patients with prediabetes-a population at increased risk-has not been systematically studied. In this planned interventional study, 80 patients meeting laboratory criteria for prediabetes will be randomly assigned to one of four groups, each receiving a different intervention for two weeks: saccharin, sucralose, erythritol, or a control group receiving water. The doses reflect the acceptable daily intake or known doses that are considered safe. After enrollment, participants will visit the study center 2 times: before starting the intervention and after completing the intervention. During these visits, biological samples such as blood, urine, and stool will be collected to study metabolism, gut bacteria, immune and blood cell function. Tests will include an oral glucose tolerance test, coagulation tests, and additional blood analyses. Additionally, participants will wear a glucose monitor to track blood sugar fluctuations during the intervention. The investigators hypothesize that consumption of alternative sweeteners negatively affects blood sugar regulation and insulin sensitivity in patients with prediabetes. Furthermore, this study will explore how the candidate sweeteners influence the gut microbiome, blood cells and other metabolic factors in this population.

In this project, the investigators aim to study how all these factors determine the cardiovascular status of a total of 1,800 mothers, 3 to 6 years after delivery. In addition, the investigators want to assess whether lifestyle and living conditions after childbirth may improve or worsen this imprint, since women often prioritize their families over themselves, making it more difficult to maintain a healthy lifestyle that could reduce their cardiovascular risk. Furthermore, the investigators will evaluate how environmental exposures influence their health, as well as explore potential strategies for prediction and prevention. The goal is to develop an easy-to-use algorithm or test that allows women and their physicians to assess this risk, ideally in the form of a mobile app. Although predictive algorithms for cardiovascular health already exist, most have been developed using predominantly male or older populations, and none have taken into account pregnancy-related events or environmental exposure - both of which are key determinants of women's cardiovascular health.

The DiCaMeR study is an observational, cross-sectional study aimed at evaluating the relationship between dietary patterns and cardiometabolic health in adults. The study includes adults following vegan, vegetarian, and omnivorous diets residing in Rosario, Argentina. Participants undergo comprehensive assessments including dietary intake, anthropometric measurements, body composition, blood pressure, grip strenght, and laboratory biomarkers related to cardiovascular and metabolic health. The main objective is to compare diet characteristics and cardiometabolic risk profiles across different dietary patterns, providing insights into the potential health benefits and risks associated with each dietary pattern.

To prevent myocardial infarction ( MI), coronary atheroma development by LDL-cholesterol deposition in the arterial wall is the basis. Since atheromatous plaques develop slowly before becoming symptomatic, their early detection in asymptomatic patients and the implementation of an effective strategy to prevent their progression constitute the most promising primary prevention strategy. In younger subjects, the main modifiable pro-atheromatous factors are smoking and an excessively high LDL-C level, partly genetically predetermined, but also favored by a diet too rich in saturated fats and a lack of physical activity. In the French national MI registry, the average age of patients is 62 years (Arch Cardiovasc Dis 2021 Oct;114(10):647-655). Half of MIs therefore occur at working age due to rupture of atheromatous plaques, which had developed during the months/years preceding the acute event. According to the latest recommendations of the European Society of Cardiology (ESC) on CV prevention published in August 2021, the visualization of coronary or carotid atheromatous plaques justifies considering the patient as having atherosclerotic cardiovascular disease (ASCVD), and automatically places them in the "very high CV risk" category, with an LDL-cholesterol target of \<0.55 g/L. However, these recommendations do not clearly define the criteria justifying the use of imaging in asymptomatic patients. In current practice, CV risk stratification for asymptomatic patients with no prior CV disease is currently based on risk calculation using the European "SCORE 2" algorithm, available online. It allows the calculation of the absolute risk in % of occurrence of a fatal or non-fatal CV event (myocardial infarction, stroke) over 10 years. The main objective of this study is to describe patients reclassified as "very high CV risk" following the detection of atheroma plaques formed in relation to their risk level estimated by SCORE2.

Who can participate? Any adults over the age of 18 who have received a kidney transplant at the research centre are eligible for recruitment within the first month after transplant What does the study involve? The study involves observing and gathering data to understand how the health of people who receive a kidney transplant changes over the first year. In particular the investigators are interested in the risk factors for heart disease and stroke, and how these change over the first year of transplant. The investigators are also interested in multiple health conditions, and how these impact patients after transplant. There are no interventions but there will be measurements of diagnoses, risk factors for heart disease and stroke, and assessments of physical fitness Blood pressure, BMI, routine blood tests as well as assessing muscle and fat changes, how fit patients are and what new health conditions they have. What are the possible benefits and risks of participating? There is no active treatment or intervention, so there are no risks of benefits compared to normal care. Where is the study run from? University Hospitals of Derby and Burton NHS trust, at the Royal Derby hospital Renal Department. When is the study starting and how long is it expected to run for? The study is expected to start 1/9/2025 and run for 2 years. Who is funding the study? The only costs of the study are funding for the staff member running the study, who is funded by the NIHR as an academic research fellow Who is the main contact? Dr Samuel Strain, [email protected]

Gender incongruence, now classified in ICD-11 as a "marked and persistent incongruence between an individual's experienced gender and the gender assigned at birth," is managed in dedicated, multidisciplinary centres that coordinate psychological support with medical-surgical care. Gender-affirming hormone therapy (GAHT) is central to this care pathway. In particular, masculinising GAHT for people assigned female at birth (AFAB) relies mainly on testosterone, and feminising or demasculinising GAHT for people assigned male at birth (AMAB) combines oestradiol with androgen-lowering agents such as cyproterone acetate or GnRH analogues (triptorelin, leuprorelin). In addition, Gender-affirming surgery (GAS) offers further individualised options: "Top" procedures- chest masculinisation for AFAB or breast augmentation for AMAB, and "Bottom" procedures\*\* such as hysterectomy with or without oophorectomy, phalloplasty or metoidioplasty for AFAB; orchiectomy or vaginoplasty for AMAB. Other ancillary interventions include facial feminisation or voice surgery. GAHT aims to suppress endogenous sex-hormone levels and secondary sex characteristics while inducing those consistent with the affirmed gender. Despite its widespread use, cardiovascular (CV) safety data are scant and largely observational. Sex-steroid receptors are ubiquitous in the vasculature and contribute to the sex-dimorphic patterns of CV risk seen in cisgender populations; GAHT is therefore biologically plausible as a modifier of CV outcomes in transgender people, yet robust evidence remains limited. Current literature suggests that AFAB individuals on testosterone exhibit an up to 2.66-fold higher composite CV risk than cisgender AFAB comparators. The most consistent changes are higher blood pressure and lower HDL cholesterol; clinically significant polycythaemia is uncommon and treatable. Instead, AMAB individuals on feminising therapy do not show a clearly increased overall CV risk compared with cisgender AMAB peers, though data are inconsistent. An observational study reported that within four months of GAHT initiation, systolic blood pressure rose by 2.6 mmHg in trans men and fell by 4 mmHg in trans women, with no diastolic change in either group. The current evidence base is weakened by small cohorts, inadequate control groups, and reliance on surrogate biochemical markers rather than hard clinical endpoints. Many studies also overlook GAHT exposure altogether, hampering meaningful interpretation. Moreover, social determinants-mental-health burden, substance use, and healthcare inequities-compound CV risk but are seldom accounted for. Key unanswered questions include the long-term CV effects of GAHT, age-specific interactions with blood pressure and lipids, optimal therapeutic targets, and underlying mechanisms. Addressing these gaps demands rigorously designed, large-scale, prospective studies that actively involve transgender participants. In summary, while GAHT is indispensable for gender affirmation, its cardiovascular implications-especially for AFAB individuals-warrant caution and systematic monitoring. Future evidence should inform tailored protocols that balance gender-affirming benefits against potential CV risks and integrate biomedical parameters with the broader social context impacting transgender health.

The goal of this study is to determine the effectiveness of a mobile exercise app in improving cardiovascular health and motivation to exercise in pregnant women who are healthy, in their 2nd trimester, between 18-45 years age, and do not do exercise currently. The aims of this study are determine i) the effect of a mobile app (BumptUp) to increase motivation to exercise as assessed by questionnaire, and ii) the changes may occur in cardiovascular health outcomes such as increased percent Flow-Mediated Dilation (FMD), Heart Rate Variability (HRV), and decreased Pulse Wave Velocity (PWV) over an 8-week period of intervention. Researchers will compare this to pregnant women who are healthy, in their 2nd trimester, between 18-45 years age, and who will not be using the mobile app (BumptUp) for exercise. Participants who are in the experimental group will be given access to the mobile app (BumptUp) for 8 weeks. Both the control and experimental group will visit the lab for their baseline measurements (study visit 1), followed by two visits at 4 weeks (study visit 2) and 8 weeks (study visit 3) to have their heart rate variability, arterial stiffness (PWV), and vascular function (FMD) assessed. At each study visit, blood pressure, heart rate, height, and weight will also be measured. Additionally, at all three study visits, participants will fill out a questionnaire to determine motivation to exercise.

The main purpose of this study was to reveal the self-worth perceptions of women who regularly participate in physical activity and to investigate the effect of physical activity on self-worth perception and cardiovascular risk awareness.

This randomized clinical trial aims to evaluate the effects of consuming two different doses of pulses (1.5 cups/week or 3 cups/week) in individuals with baseline intake below 1.5 cups/week, compared to a control group receiving standard nutrition education based on the United States Department of Agriculture's (USDA) My Plate guidelines. The main question the Pulses study aims to answer is: • What is the effect of increasing pulse consumption (in a dose-response manner) on specific cardiometabolic risk factors, including LDL-C, CRP, HBA1C, and blood pressure compared to standard nutrition education? For secondary outcomes, this study aims to answer the following: • Does increased pulse consumption improve the following: overall serum lipid profile (Total cholesterol (TC), HDL-C, Triglycerides (TG), diet quality (measured by the Healthy Eating Index), and participants self-reported satisfaction with life (SWLS) and Satisfaction with Food-related Life (SWFoL). All participants will attend biweekly classes and food demonstrations. The pulses groups will learn to prepare various pulse-based recipes, while the control group will receive guidance on preparing healthy meals following the USDA MyPlate recommendations.