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170 active trials for Cardiovascular Risk Factor

Effectiveness of Nurse-coordinated Follow-up Program in Primary Care for People at Risk for T2DM

Previous Icelandic studies regarding prevalence of diabetes have mostly used data from the capital area. Information on the proportion of people at risk at developing T2DM or having undiagnosed T2DM among people living in rural Northern Iceland is unknown. Clinical guidelines recommend that patients with prediabetes (diabetes warning signs) should be referred to a counselling program. The study will evaluate effectiveness of nurse-coordinated Guided Self-Determination (GSD) follow up program toward health promotion, for people at risk of T2DM.

Start: January 2021

Women's Advanced Risk-assessment in Manitoba

The main objective of this study is to test the ability of novel cardiovascular disease (CVD) prognostic tools to identify women at risk for future CVD. We plan to establish a cardiovascular health screening program at the St. Boniface Hospital and to test the efficacy of these tests for predicting adverse cardiovascular outcomes amongst a cohort of 1000 Manitoban women aged 55 years and older in the 5-year period after screening. A second purpose of this project is to identify novel CVD biomarkers that may indicate a person is at risk for cardiovascular disease. Therefore, we plan to ask participants for permission to collect and store a sample of both their blood and stool for future research.

Start: October 2019

Therapeutic Approach of Cardiovascular Risk Factors in T2DM by Gender

Background: Patients with type 2 diabetes mellitus (T2DM) are at 2- to 4-fold higher risk of cardiovascular mortality compared with non-diabetic subjects. Cardiovascular disease (CVD) is the main cause of death in almost half of diabetic population in Spain. Female patients with T2DM have up to 40% excess risk of CVD compared with men and the causes are still unknown. It is argued that a tight control of cardiovascular risk factors could improve the situation. Hypothesis: The cardiovascular risk factors management in women with T2DM is different than in men with T2DM. Aims: To assess the therapeutic approach of cardiovascular risk factors and the occurrence of cardiovascular events among women in comparison to men with T2DM. Methodology: Observational study based on clinical records of primary health care from T2DM patients in Catalonia (2007-2013). Source: SIDIAP database. Analysis: The two study groups (women and men) will be matched to ensure balance in terms of basal comorbidities and previous cardiovascular disease in order to describe the study group characteristics and to perform a multivariate modeling approach. Applicability and Relevance: This study is intended to serve to identify the points of improvement of the cardiovascular risk factors therapeutic approach in women.

Start: January 2017

Personalized Lifestyle Intervention for Improving Functional Health Outcomes Using N-of-1 Tent-Umbrella-Bucket Design

The LIFE-HOUSE research project is designed to evaluate the impact of a personalized lifestyle intervention program on functional capacity as an approach to quantitating health, and its relationship to well understood disease risk determinants. LIFE-HOUSE will utilize an innovative Tent-Umbrella-Bucket design. Participants will gather under the Tent of an all-inclusive 'N of 1' Case Series providing a shelter of Functional Medicine interventions against the storm of chronic disease. Under this Tent are a collection of Umbrellas where participants with similar clinical challenges are evaluated as clinically defined groups with loose guidelines for the planned interventions. Finally, participants standing under these Umbrellas may step into specific Buckets that gather individuals with nearly identical clinical presentations into more formally described prescriptive randomized arms for intervention. Individuals will be offered the opportunity to participate in all Umbrellas and Buckets for which they qualify. They may accept or reject participation in any Umbrella or Bucket and yet remain eligible for participation in the overall Tent.

Start: September 2018

Effect Levosimendan Administration on Postoperative NT-proBNP in Cardiac Risk Patients

This is a prospective randomised trial investigating the effect of a preemptive administration of levosimendan on postoperative cardiac NT-proBNP concentrations.

Start: October 2020

Biomechanical Precision Medicine Registry for Patients With and Without Heart Failure

In this single-center, longitudinal observational study, we will comprehensively examine clinical characteristics, proteomic, metabolomic, genomic and imaging data to better understand how different heart failure types may develop and progress over time. We will evaluate distinct sub-groups of heart failure (also known as heart failure phenotypes) with an ultimate goal of bringing the right medications and therapy to the right patients to optimize benefit and minimized side effects, an effort to improve precision medicine in heart failure.

Start: April 2016

Mediterranean Enriched Diet for Tackling Youth Obesity

The prevalence of obesity is one of the main public health problems worldwide, reaching 18% among young people between 5 and 19 years of age in 2016. One possibility of effective treatment can be the Mediterranean diet (MD). Therefore, it is proposed to carry out a nutritional intervention based on this diet to more effectively reduce obesity in adolescents. The main purpose of this multicentre study is to assess whether an energy-restricted Mediterranean-style diet (MD) intervention including healthy products from the Mediterranean basin (mixed nuts, pomegranate and hummus) and sourdough bread is more effective against obesity and associated CVD risk factors than a conventional low-fat diet carrying out a multicentre nutritional and clinical intervention study specifically targeting obese/overweight adolescents (13-17y) from different Mediterranean countries; all combined with an educational web-application designed to encourage healthy behaviours. It is a multicenter, randomized, controlled intervention study conducted with adolescents with obesity/overweight ?90 percentile who do not suffer from any chronic disease. 240 subjects will be recruited from three Mediterranean countries: Italy (Parma), Portugal (Coimbra) and Spain (Reus), specifically 80 participants per country, 40 adolescents as an intervention group and 40 as a control group, in Reus. The intervention study is scheduled to begin in January 2021. The intervention group will receive a diet based on the characteristics of MD, and will be reinforced with satisfying and healthy Mediterranean foods such as sourdough bread (2 servings of 50-60g / day), squeezed pomegranate (4 servings of 200ml / week), hummus/chickpeas (2 portions of chickpeas of 150-200g / week, one in hummus format) and mixed nuts (4 servings of 30g / week); and the control group will receive a recommended diet based on the consumption of low-fat foods. A caloric restriction of 20% of the total energy requirements will be applied to both groups in adolescents with BMI ?95 percentile (obesity) and a caloric restriction <20% of the total energy requirements will be applied in adolescents with BMI ?90 to <95th percentile according to overweight (gender/age / physical activity). The diet will be applied for 4 months in both groups. Adolescents from both groups will be given a motivational interview and will be provided with an educational website that will be used during the intervention, through which they will learn.

Start: January 2021

Resistance Plus Aerobic Training Using Different Weekly Frequencies And Hypertension

Combined training is a cornerstone intervention to improve functionality and to reduce blood pressure in older adults with hypertension. Acute blood pressure lowering after exercise seems to predict the extent of blood pressure reduction after chronic training interventions. Based on that, the same weekly amount of exercise performed more frequently could be more beneficial to blood pressure management. The aim of the present study is to evaluate the effects of a combined exercise program performed four versus two times per week on 24-h ambulatory blood pressure and other cardiovascular risk factors in older individuals with hypertension.

Start: March 2021

Southampton Women's Survey

The Southampton Women's Survey was established to assess the influence of factors operating before conception and during pregnancy on the health and development of the offspring. 12,583 non-pregnant young women were recruited, and 3,158 were followed through pregnancy, with their offspring followed-up at 6 months and 1, 2, 3, 4, 6-7, 8-9 and 12-13 years. The 17-19 year follow-up has been piloted and is about to start.

Start: April 1998

The Influence of Mitochondrial-Derived Reactive Oxygen Species on Racial Disparities in Neurovascular Function

Black individuals are at increased cardiovascular disease risk. The central goal of the study is to determine if mitochondrial reactive oxygen species influence blood vessel function and nervous system regulation of blood pressure differentially in black, compared to white individuals. These findings may help to explain a potential mechanism that contributes to racial disparities in blood pressure and cardiovascular disease risk. A secondary goal is to determine if mitochondrial reactive oxygen species improves blood pressure and vascular function in individuals with elevated blood pressure and stage 1 hypertension.

Start: October 2020

BerryCare: A Community Engagement Program

BerryCare teaches people about the health benefits of blackberries, how to harvest and maintain blackberry bushes and then assesses changes in knowledge and behaviors associated with blackberries and physical measurements.

Start: January 2017

Cardiac and Immune Cell Function in Preeclampsia

Preeclampsia is a multi-system vascular disease which affects 2-5% of pregnancies. It is also a risk factor for the development of cardiovascular disease later in life and a number of functional and structural cardiac changes have been found in this population of patients. In mouse models disruption of a group of immune cells, neutrophils, has led to alteration of the placenta and offspring consistent with those seen in preeclampsia. These mice also have an abnormal cardiac function and structure (Nadkarni et al 2016). The investigators hypothesis that this may also occur in humans. This study aims to intimately link the maternal immunological and vascular components of cardiac dysfunction in women preeclampsia. The investigators hypothesise that in preeclampsia activated neutrophils may affect maternal immune system thus leading to myocardial injury and altered cardiac function. The study intends to identify the mechanisms by which the maternal immune system (focusing on neutrophil and T-cell subsets) affects cardiac function in women with preeclampsia. Specific aims to be addressed are: Aim 1: To correlate specific neutrophil phenotype(s) and function to cardiac function in women with preeclampsia during pregnancy Aim 2: To test whether specific activated neutrophil phenotype persists postpartum and whether this neutrophil phenotype correlates with cardiac function in women with preeclampsia postpartum The study population will comprise of 3 groups: Normotensive pregnant (~33 patients) Pregnancy-induced hypertension (PIH; New-onset hypertension after 20 weeks without proteinuria; ~33 patients) Preeclampsia (~34 patients) Cardiac function will be evaluated using cardiovascular magnetic resonance, echocardiography and cardiac markers in the blood. The participants immune system will be assessed from blood samples looking at the immune cells, hormone levels and inflammatory and non-inflammatory mediators. The secondary research objective is to investigate whether changes in the immune system and cardiac function in participants is persistent after delivery. Therefore participants will have scans and blood tests both antenatally and at 3 months postnatally. By identifying key changes in immune cell type and function with cardiac abnormalities in women with preeclampsia, data obtained from this study could provide novel insight into how the maternal immune system influences cardiac changes in normal and preeclamptic pregnancies. Identifying such links could pave the way for future therapeutic targets.

Start: November 2020

The Effect of Lifestyle Intervention on Cardiovascular Disease Risk Among Women

Patient education in lifestyle changes has a positive effect on health in individuals with cardiovascular (CV) risk. Despite current positive evidence about lifestyle and dietary change in the prevention of CVD, the recommendations are still not consistently and optimally applied to women. The aim of the study was to analyze the effect of an intervention in the form of Cochrane abstract letters on women between 45 to 65 years.

Start: February 2018

Cannabis Inhalation: Effects on Cardiovascular Function During Rest and Exercise

This two-phase project seeks to examine the cardiovascular response to consumption of cannabis variants of different cannabinoid composition through different methods (smoking vs. vaporizing), at rest and during aerobic exercise. Multiple measures that have been shown to predict risk factors for chronic-disease and negative health outcomes will be assessed following cannabis consumption at rest or in combination with exercise. These techniques will examine arterial stiffness, vascular function, and cardiac function. In phase I and II, subjects will visit the lab on 6 different occasions; with 1 visit acting as an introductory visit, 1 as an exercise control visit, 2 as resting cannabis visits, and 2 as cannabis + exercise visits. Cannabis used in phase I of this study will consist of approximately 10% THC. On all visits, pulse wave velocity, flow mediated dilation, and echocardiography measures will be performed following cannabis consumption by smoking or vaporizing, and cannabis consumption by smoking or vaporizing followed by 20 minutes of exercise on a cycle ergometer. Phase II of the study will implore a similar design. In favor of altering method of consumption, in all visits cannabis will be consumed by vaporization and will be either a high cannabidiol (CBD: (~10%)) and low delta-9-tetrahydrocannabinol (THC: (<1%)), or a high THC (~10%) and low CBD (<1%) variant.

Start: September 2021

Active You: Feasibility of a Unique Physical Activity Program to Prevent Diabetes and Heart Disease

Individuals who are overweight/obese are more vulnerable to type 2 diabetes (T2D). Current evidence suggests that PA, even without dietary prescription, can be efficacious in preventing T2D. Yet most Americans, especially those who are overweight/obese, are not physically active. Socioenvironmental barriers to physical activity (PA) such as body image concerns and limited access to fitness facilities contribute to the low levels of PA observed in overweight/obese adults. Web-based PA programs have been developed to address these barriers, but the outcomes have been marginal. Qualitative studies suggest that individuals who are overweight/obese prefer PA programs that feature people they can relate to especially in body size, fitness status and age. Previously, the investigators have included these preferences in a technology-based Physical Activity for The Heart (PATH) intervention that leverages open source platforms, such as YouTube, to promote PA in any setting. In this application, the investigators propose to test the feasibility and preliminary efficacy of PATH in promoting PA and reducing cardiometabolic risk in adults who are overweight/obese and at high risk of diabetes. In Aim 1 the investigators will conduct a 12-week randomized clinical trial including 52 adults who are overweight/obese and at high risk of diabetes to assess the feasibility and acceptability of PATH. In Aim 2 investigators will examine the trend in PA and cardiometabolic risk change from baseline to post-intervention. This approach is innovative because it leverages open source technologies to provide low-cost, action-oriented PA resources that match the preferences of adults who are overweight/obese. This contribution will be significant because PATH could offer a convenient, enjoyable and scalable program that features "similar others" to promote PA in overweight/obese adults at high risk of diabetes.

Start: October 2020

Pre-eclampsia and Future Cardiovascular Health: An Underused Opportunity to Improve Family Health

Background: PE (pre-eclampsia) is a common pregnancy-specific vascular hypertensive disease affecting 3-5% of pregnancies. PE independently increases the risk for premature cardiovascular disease (CVD) in mothers and their offspring long-term. PE provides a unique window for early risk profiling and CVD prevention. However, the efficacy of a family oriented lifestyle intervention to lower CVD risk in families with history of PE has not previously been evaluated. Aim: This study will explore the impact of PE on CVD progression 8-12 years from delivery in mothers and their children, and assess whether a lifestyle intervention is useful for lowering mother and child blood pressure and improving the CVD risk profile overall in families with a history of PE. Hypothesis: PE is related with CVD progression mediated by elevated blood pressure. Blood pressure and the CVD risk profile overall is modifiable in mothers and children by a 12-month behavioral lifestyle intervention in families with a history of PE. Study design: Randomized controlled behavioral lifestyle intervention trial where families (mother, child and father from the FINNPEC study) are offered the opportunity to participate in a lifestyle intervention program 8-12 years after a PE pregnancy. 300 PE families will be randomized 1:1 to a 12-month lifestyle intervention program or to a control group. A parallel group of 100 non-PE control families will be assessed at baseline and follow-up. Main outcome: 24 hour mean blood pressure change between baseline and follow-up in mother and child. Significance: This study will provide information on CVD progression in mothers and children 8-12 years from a PE pregnancy. Furthermore, the study assess the effect of a 12-month lifestyle intervention on blood pressure and CVD risk profile overall following a PE pregnancy. Potentially, the study provides the opportunity to identify PE families at highest risk of CVD progression and families amenable to blood pressure and CVD risk profile improvement.

Start: June 2019

Active You: A Novel Exercise Program for African Americans

Barriers to physical activity (PA) among African Americans (AAs) have been extensively studied, yet there is a paucity of innovative PA interventions designed to address them. In recent years, many studies have used the internet to promote PA in many settings, including the home environment, but only a few studies have recruited AAs. Without innovative and culturally relevant interventions, AAs will continue reporting extremely low levels of PA and disparate cardiovascular health outcomes. In prior work, the investigators sought the input of AA focus groups to inform the development of a technology-based Physical Activity for The Heart (PATH) intervention that leverages openly accessible platforms, such as YouTube, to promote PA in any setting. The investigators designed PATH as a culturally salient action-oriented intervention that can be accessed in any setting to promote PA among inactive AAs. In this application, the investigators propose to examine whether PATH is a feasible strategy for promoting PA among inactive AAs. In Aim 1 the investigators will conduct a randomized clinical trial that will include 30 inactive AAs to assess the feasibility and acceptability of the PATH intervention. In Aim 2 the investigators will examine the trend in PA and cardiovascular disease risk change from baseline to post-intervention. This approach is innovative because it leverages openly accessible technologies to provide a wide variety of free, enjoyable and action-oriented workout videos that match AAs preferences. This contribution will be significant because PATH could offer a novel, low-cost, and scalable strategy for promoting PA among individuals facing socio-environmental barriers to PA.

Start: October 2020

Effect of 4 Weeks of Citrulline and Glutathione Supplementation on Arterial Function

Examining the effects of 4 weeks of Citrulline alone or in combination with glutathione on the arterial function of postmenopausal women.

Start: July 2020

The Effect of Omega -3 Supplements on the Serum Levels of ACE/ACE2 Ratio as a Potential Key in Cardiovascular Disease and COVID-19; A Randomized Clinical Trial in the Covid-19 Uninfected Jordanian People

The Renin-Angiotensin-Aldosterone System (RAAS) is involved in blood pressure regulation and electrolyte balance. Angiotensin-converting enzyme (ACE) is a critical regulator of RAAS by cleaving angiotensin (Ang1) to Angiotensin2 (Ang2), which is the most powerful biologically active product of RAAS [1]. In the same context, angiotensin-converting enzyme 2 (ACE2) converts Ang2 to Ang (1-7), which is a vasodilator, antithrombotic, and antihypertrophic peptide [2]. ACE2 which is found in many tissues [3] has opposite effects to ACE on the heart, kidneys, and lungs [4]. Many pathological conditions, in particular cardiovascular disease (CVD), have shown a link between a disturbance in ACE/ACE2 ratio and the downregulation of ACE2 levels [5]. Also, ACE/ACE2 has been reported to be higher in moderate to severe chronic heart failure [6] as well as systolic blood pressure [7]. Recently, an elevated ACE/ACE2 ratio is linked to Coronavirus disease 2019 (COVID-19). SARS-COV2 enters target cells by binding of the spike protein to ACE2 and a specific transmembrane serine protease 2 (TMPRSS2) for the spike (S) protein priming, which also leads to downregulation of ACE2 [8]. Down-regulation of ACE2 caused by Coronavirus may have a potential role in the pathogenesis of COVID-19 infection. Accordingly, people with a higher ACE/ACE2 ratio may be more at increased risk of worse Covid-19 consequences [9]. On the other hand, omega-3 fatty acids could decrease CVD risk by their anti-inflammatory anti-thrombotic function [10]. A meta-analysis comprising 15,806 patients, showed that omega-3 fatty acids associated with a 30% reduction in fatal myocardial infarction and sudden death, in addition to a 20% reduction in overall mortality [11]. To the best of our knowledge, no clinical trials have evaluated the effect of omega-3 supplementation on serum ACE/ACE2 ratio which is recently ascribed as a potential key in 2019 Covid-19 as well as CVD [5,9].

Start: December 2020

Chinese Multi-provincial Cohort Study-Beijing Project

The Chinese Multi-provincial Cohort Study (CMCS)-Beijing project is a sub-study in CMCS participants from Beijing, which intended to investigate the progression and determinants of atherosclerosis and aging related health problems through repeat examinations. Exam 0 to Exam 3 have been conducted during 1992 to 2012. Exam 4 is scheduled in 2020.

Start: September 2020