Cardiovascular Diseases Clinical Trials in United Kingdom

The risk of cardiovascular disease is determined by the complex interplay between an individual's genetic make-up, lifestyle, and the environment. The researchers in this observational, cross-sectional, recall-by-genotype study are investigating two potential genetic risk factors; the SWAP70 gene is thought to play a role in the immune response modulating cardiovascular disease risk and the GMPR gene plays a role in red blood cell formation. The investigators hope to identify and characterise distinct molecular and cellular mechanisms underlying candidate functional variants identified in genetic studies of cardiovascular and immune-related human traits and diseases. Healthy volunteers who are part of the NIHR BioResource and have already been genotyped will be invited to the study based on their genotype of the candidate functional variants of interest. Volunteers will attend a single study visit, during which they will complete procedures including a medical, demographic and lifestyle factors questionnaire; height, weight and body fat assessments; in addition to blood pressure/heart rate measurements. A minimally invasive procedure of a venepuncture will be performed to assess the primary objectives of the study. The obtained data may (1) improve understanding of biological and disease mechanisms; (2) identify potential drug targets; and (3) improve insight into the therapeutic potential and limitations of existing and emerging therapies. This study is funded by the UK Medical Research Council, British Heart Foundation and NIHR Cambridge Biomedical Research Centre. Read Less

The purpose of this study is to understand more about why women who have had hypertensive pregnancies may be at increased risk of high blood pressure and why these women are often at increased risk of heart and blood vessel disease later in life. Read Less

The Genetics and Vascular Health Check study (GENVASC) is a large study run in conjunction with Clinical Commissioning Groups and Primary Care practices across Leicester, Leicestershire and Northamptonshire. The purpose of GENVASC is to help determine whether gathering genetic information can improve the prediction of risk of Coronary Artery Disease (CAD). Currently, coronary risk scores are used to put individuals into low (\<10%), medium (10-20%) and high (\>20%) risk groups to help target prevention in individuals at the highest risk of developing CAD. While this approach has merit, since the majority of individuals fall into low or medium risk groups, in absolute terms more people develop CAD in these groups than in the high risk group (despite their proportional risk being lower). Therefore, improving the accuracy of risk categorisation for CAD has important public health and clinical benefits. In the last 5 years there has been remarkable progress in identifying genetic variants that affect risk of CAD, with much of this work being co-led from Leicester. These discoveries provide a framework for testing whether the addition of genetic information in the form of a genetic risk score can improve current risk prediction of CAD. The GENVASC study capitalises on the unique opportunity provided by the NHS Health Check Programme, which is being widely promoted and specifically targets all individuals aged 40-74 years who are free of cardiovascular disease. Consenting participants taking part in the health check programme are asked to provide an additional sample of blood to subsequently determine whether the addition of genetic information would have improved prediction of risk for coronary disease in individuals at low/medium risk. To date more than 100 GP surgeries in Leicester and Leicestershire are involved in the study, and recruitment has recently commenced in Northamptonshire . We aim to recruit and follow-up over 30,000 participants over the course of the study. Read Less

This project will examine the diagnosis and prognosis of patients with cardiovascular disease in hospital in- and outpatients and compare their characteristics with normal controls from the community. The cardiovascular diseases studied include coronary artery disease, heart failure, heart attacks, valve disease, cardiac surgery, dysrhythmias, aneurysms, embolism, strokes, peripheral vascular disease and hypertension. Current methods for diagnosis and predicting outcome in patients are limited and may lack accuracy. This study will collect clinical details, and blood and urine samples from patients for analysis of proteins, chemicals and genetic biomarkers which will enable an examination of the pathological mechanisms involved in cardiovascular disease. The data will also be used to improve diagnosis and also improve prediction of outcome in patients (future clinical events such as death, further hospitalisation with cardiovascular disease and the effects of any therapy given to the patients). In this way, we can develop accurate ways of assessing a patient's condition and how it could be effectively managed. The study will last for 20 years. Read Less

Bicuspid aortic valve (BAV) is the most common congenital heart anomaly in the general population (1-2% of all individuals). In affected people, the aortic valve (the structure ensuring one way blood flow between the heart's left pumping chamber, the left ventricle and the main body artery, the aorta) consists of 2 rather than 3 leaflets. This arrangement can cause the affected valve to have restricted opening or cause it to leak. Both situations put strain on the heart and patients with BAV across the age range may require surgery to replace the affected valve. BAV is therefore a condition associated with significant ill health and early mortality. BAV is known to cluster in families and is likely to have a genetic cause. We don't fully understand the inheritance of BAV or the specific genes involved in its development. Learning more about this is the basis of the BRAVE study. We will ask patients with BAV and their relatives (who may or may not have BAV) to take part in the study. Blood samples obtained from the participants will be used for analyses of their genetic composition. This information, linked with the clinical data concerning who does and does not have BAV, will potentially enable the identification of the gene changes responsible for the disease. This, we hope, will give us a much better understanding of the mechanisms leading to this serious and common condition. Read Less

This is an international prospective, multicentre, unblinded, randomised-controlled trial. The primary aim is to assess a targeted screening strategy to detect undiagnosed heart failure in high-risk patients. Read Less

This study aims to find out whether people with chronic kidney disease \[CKD\] should take low dose aspirin to reduce the risk of first heart attack or stroke (cardiovascular disease \[CVD\]). CKD is common and is associated with an increased risk of CVD. CVD is caused by small blood clots and aspirin thins the blood to reduce the risk of such clots developing but it also increases the risk of bleeding. Aspirin is recommended to prevent further CVD in people who have already had a first CVD event (so called secondary prevention). Here the investigators want to study the use of aspirin as primary prevention in people with CKD who have not had a CVD to prevent the first event, to assess whether the potential benefits exceed the risks. Eligible patients will be recruited from their United Kingdom (UK) general practices and allocated by chance to be prescribed once daily low dose aspirin or usual care only. Follow-up will be for several years both electronically (for general practice, hospital and mortality data) and by annual questionnaires to ascertain CVD and bleeding events. Read Less

Sleep difficulties are common following stroke yet effective evidence-based interventions for improving sleep in this population are lacking. A small number of studies have investigated the use of music listening as a way to improve sleep in adults with insomnia. This study aims to examine whether a mindful music-listening intervention can reduce subjective and objective insomnia symptoms and improve mood and fatigue post-stroke. Six adults with a clinical diagnosis of stroke presenting with an insomnia disorder will be recruited from stroke services within NHS Greater Glasgow and Clyde. A multiple baseline single case experimental design will be employed. Participants will be randomly allocated to a baseline phase of 7, 11 or 15 days, followed by a five-week mindful music-listening intervention incorporating sleep hygiene. Changes in subjective and objective sleep will be measured using questionnaires and actigraphy, respectively. Mood and fatigue will also be measured. The data will be analysed using visual inspection, Tau-U and multi-level modelling. Read Less

The purpose of the study is to determine whether MRI guided CRT implantation (using Siemen's software prototype) is superior to standard treatment in terms of CRT response. Data will be collected at enrolment, implant, pre-discharge, 6 weeks and 6 months. The total duration of the investigation will be 6 months. The primary endpoint will be assessed by calculating the difference in the proportion of responders (\>15% reduction in end systolic volume derived from 2-dimensional transthoracic echocardiogram at 6 months post CRT implant). Read Less

This is a prospective, multicentre, unblinded, randomised, controlled trial. The primary aim is to assess a targeted screening strategy to detect undiagnosed heart failure in high-risk patients with diabetes. Read Less

The purpose of this study is to understand more about why young people who were born to a hypertensive pregnancy may have increased risk of high blood pressure and are often at increased risk of heart and blood vessel disease later in life. Read Less

The European NAFLD Registry is a prospectively recruited, observational study supporting the study of the clinical phenotype, natural history, disease outcomes and pathophysiology of Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis. The ultimate goals are to better understand the drivers of interpatient variation in disease pathophysiology and severity and to utilise this information to develop and validate biomarkers that, singly or in combination, enable detection and monitoring of disease progression and/or from NAFL through NASH to fibrosis and cirrhosis. Read Less