[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Leicester\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":669},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,32,0,25,[9,56,89,117,144,172,198,222,240,261,285,312,339,368,385,409,439,466,497,521,549,575,599,625,649],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":34,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100507429","phase-2-a-randomised-controlled-trial-of-a-low-energy-diet-for-improving-functional-status-in-heart-failure-with-preserved-ejection-fraction-preserved-ejection-fraction-100507429",false,"NCT05887271","A Randomised, Controlled Trial of a Low-energy Diet for Improving Functional Status in Heart Failure With PRESERVED Ejection Fraction Preserved Ejection Fraction","A Multi-Ethnic, Multi-centre raNdomised, Controlled Trial of a Low-energy Diet for Improving Functional Status in Heart Failure With PRESERVED Ejection Fraction (AMEND-preserved)","AMEND","Inclusion Criteria:\n\n1. Established clinical diagnosis of heart failure with preserved ejection fraction HFpEF (EF\\>45%) made by a cardiologist or a primary care physician with heart failure expertise, or a heart failure nurse\n2. Clinically stable for ≥ 3 months (no admissions to hospital)\n3. Obesity (BMI ≥30kg\u002Fm2 if white European or ≥27kg\u002Fm2 if Asian, Middle Eastern or Black ethnicity)\n4. Age ≥18\n\nExclusion Criteria:\n\n1. Inability to walk\u002Fundertake 6-minute walk test\n2. Inability to follow a low-energy MRP\n3. HFpEF due to infiltrative cardiomyopathy (cardiac amyloidosis or sarcoidosis), genetic hypertrophic cardiomyopathy, restrictive cardiomyopathy\u002Fpericardial disease or congenital heart disease.\n4. Recovered EF (previous EF \\\u003C 40%) unless reduced EF was in context of tachycardia induced cardiomyopathy (eg AF\u002FAflutter).\n5. Known heritable, idiopathic or drug-induced pulmonary arterial hypertension\n6. Severe chronic obstructive pulmonary disease (FEV1\\\u003C 1.0L)\n7. Severe primary valvular heart disease\n8. Anaemia (Hb\\\u003C100g\u002FL)\n9. Severe renal disease (eGFR \\\u003C 30 ml\u002Fmin\u002F1.73 m2)\n10. Weight loss \\> 5kg in preceding 3 months.\n11. Symptomatic gallstones (including biliary colic) or cholecystitis within last 3 months\n12. Active substance abuse (drugs or alcohol)\n13. History of bariatric surgery in the last 3 years\n14. Active illness likely to cause change in weight\n15. Women who are pregnant or are considering pregnancy\n16. People currently participating in another clinical research trial that is likely to affect diet or weight change.\n17. History of a severe mental illness including an eating disorder\n\n17\\. Individuals with a diagnosis of Type 1 diabetes mellitus.","ALL","18 Years",{"count":21,"type":22},63,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE2","PHASE3","Heart failure with preserved ejection fraction (HFpEF) is a common and serious complication of obesity and type 2 diabetes (T2D). HFpEF occurs when the heart muscle unable to relax efficiently to pump the blood around the body. This leads to fluid build-up, breathlessness and inability to tolerate physical exertion. People who develop HFpEF do less well because treatment options are limited. Pilot data in patients with obesity and diabetes and a small number of patients with HFpEF have shown improvements in exercise capacity and reversal of changes in the heart and blood vessels. This study will assess if this is achievable in a multi-ethnic cohort of patients with established HFpEF. A total of 63 adults will be invited and allocate by chance into two groups: 1) 12-weeks of a low calorie diet or 2) Standard care and health advice on how to lose weight followed by the option to have the low calorie diet after 12-weeks. The study will determine if weight loss over 12 weeks can improve heart function, symptoms and ability to exercise. Additionally, participants' views on changing their diet and how this has impacted their symptoms will be sought during the study in an optional interview. This will help guide treatments planning in the future to get maximum benefits, and to individualize support to patients from different cultural backgrounds.",[29,30,31,32,33],"Heart Failure With Preserved Ejection Fraction","Heart Failure, Diastolic","Diabetes Mellitus, Type 2","Diabetes Mellitus Type 2 in Obese","Obesity Adult Onset",[35,36,37,38,39,40,41,42],"Heart failure with preserved ejection fraction","Diastolic heart failure","Type 2 diabetes mellitus","Obesity","Meal replacement plan","Cardiac magnetic resonance imaging","Exercise intolerance","Diabetes remission","RECRUITING","2026-06-22",{"date":46,"type":47},"2026-06-25","ACTUAL",{"date":49,"type":47},"2023-12-05",{"date":51,"type":22},"2026-06-30",{"name":53,"class":54},"University of Leicester","OTHER",3,{"id":57,"slug":58,"hasResults":12,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":12,"sex":18,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":23,"phases":67,"briefSummary":69,"conditions":70,"keywords":74,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100642620","active-airways-for-children-and-young-people-with-asthma-100642620","NCT07643753","Active Airways for Children and Young People With Asthma","The Feasibility of an Exercise and Asthma Educational Programme 'Active Airways' on Health Outcomes in Children and Young People With Asthma With All Severities","Inclusion Criteria:\n\nWilling and able to consent to participate in the trial\n\nAble to understand written and spoken English\n\nA diagnosis of Mild to Moderate Asthma or Severe Asthma based on the European Respiratory Society (ERS)\u002F American Thoracic Society (ATS) consensus statement on Severe Asthma\n\nAble to participate in a formal exercise programme\n\nAged 10-17 years\n\nAble to engage in focus groups\n\nApproximately 130cm tall (to be able to complete cardiopulmonary exercise testing (CPET))\n\nExclusion Criteria:\n\nSelf-reported uncontrolled severe exercise-induced breathlessness\n\nRequired a course of antibiotics or oral corticosteroids within the 4 weeks prior to the study commencing\n\nChildren with severe co-morbidities that will not allow them to participate in an exercise programme e.g. Severe neuromuscular disorders, recent fractures or surgeries, cognitive or behavioural conditions.\n\nParticipant is unable or unwilling, in the opinion of the investigator, to give informed consent","10 Years","17 Years",{"count":66,"type":22},60,[68],"NA","What is this study about? The investigators want to see if exercise and education sessions can help children and young people (aged 10-17) with asthma, manage the participants asthma better.\n\nThe investigators will place participants that are recruited to this study into one of three groups by a computer (randomly):\n\nGroup 1:\n\nUsual Care: Continue with normal asthma treatment.\n\nGroup 2:\n\nEducation: Usual care + a 45-minute online asthma education class once a week.\n\nGroup 3:\n\nExercise \\& Education: Usual care + 3 exercise sessions a week and asthma education classes.",[71,72,73],"Asthma Childhood","Exercise","Children",[75,76,77,78],"asthma","children","exercise","physical activity","NOT_YET_RECRUITING","2026-06-09",{"date":82,"type":47},"2026-06-11",{"date":84,"type":22},"2026-07",{"date":86,"type":22},"2030-09",{"name":53,"class":54},1,{"id":90,"slug":91,"hasResults":12,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":99,"phases":4,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":88},"100642333","mediators-of-loin-pain-in-iga-nephropathy-100642333","NCT07649538","Mediators of Loin Pain in IgA Nephropathy","LO-PAIgN: Mediators of Loin Pain in Immunoglobulin-A Nephropathy","LO-PAIgN","Inclusion Criteria:\n\nCohort A\n\n1. ≥18 years of age at the time of recruitment\n2. IgAN diagnosis confirmed with a renal biopsy\n3. Episodic\u002FIntermittent Loin Pain (defined as pain at least once every 6 months)\n4. Have the capacity to consent to the study Cohort B\n\n1\\) ≥18 years of age at the time of recruitment 2) IgAN diagnosis confirmed with a renal biopsy 3) No history of loin pain 4) Have the capacity to consent to the study\n\nExclusion Criteria:\n\nCohort A\n\n1. Constant loin pain\n2. Infrequent loin pain (no pain experienced in the last 6 months)\n3. Inability to differentiate loin pain from back pain\n4. Other renal diseases\n5. Therapies that interfere with immune-mediation like steroids and complement inhibitors\n6. Kidney transplant recipients\n7. Current participation in an interventional study that may affect kidney function\n8. Patients on dialysis\n9. Patients with implants that are not MRI-safe (pacemakers, implantable defibrillators, cochlear implants, some shunts, neurostimulators, some aneurysm clips, etc.)\n\nCohort B\n\n1. Other renal diseases\n2. Therapies that interfere with immune-mediation like steroids and complement inhibitors\n3. Kidney transplant recipients\n4. Current participation in an interventional study that may affect kidney function\n5. Patients on dialysis\n6. Patients with conditions\u002Fimplants that are not MRI-compatible (claustrophobia, pacemakers, implantable defibrillators, cochlear implants, some shunts, neurostimulators, some aneurysm clips, etc.)",{"count":98,"type":22},40,"OBSERVATIONAL","The goal of this observational study is to learn about loin pain in people with Immunoglobulin A nephropathy (IgAN).\n\nThe main question it aims to answer is:\n\nWhat changes occur in the kidneys, urine, and blood when people with IgAN experience loin pain?\n\nParticipants will have MRI scans of their kidneys, provide urine and blood samples, and have their latest kidney function test results reviewed. For participants who experience loin pain, these assessments will be carried out during a pain episode and again when they are pain-free, so the results can be compared.",[102],"IgA Nephropathy (IgAN)",[104,105,106,107,108,109],"Kidney pain","IgAN","IgA nephropathy","Flank pain","Loin pain","Renal pain",{"date":111,"type":47},"2026-06-16",{"date":113,"type":22},"2026-08-20",{"date":115,"type":22},"2028-06-02",{"name":53,"class":54},{"id":118,"slug":119,"hasResults":12,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":99,"phases":4,"briefSummary":126,"conditions":127,"keywords":133,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":88},"100577751","hospital-environmental-exposure-100577751","NCT06802367","Hospital Environmental Exposure","Environmental Exposures in a Clinical Setting: the Impact on Patients","Inclusion Criteria:\n\n* Hospital admission with a diagnosis that requires at least 2 nights.\n* Participant is willing and able to give informed consent for participation in the study. If a patient for example has dementia and\u002F or the inability to retain information or if they are unable to wear the device, they will not be consented.\n* Aged 18 years or above.\n* Able (in the ward staff, research team and investigator's opinion) and willing to comply with all study requirements.\n\nExclusion Criteria:\n\n* Any significant disease or disorder which, in the opinion of the investigator, may either put the participants or other patients at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.\n* Reported history of sleep disorders, including obstructive sleep apnoea syndrome (OSAS) or insomnia.",{"count":125,"type":22},120,"There is an increasing body of evidence that human health is affected by environmental factors such as air quality, noise and light. This applies to both indoor and outdoor environments. While there have been several studies looking at homes, offices and work environments, hospital environments are still poorly characterised. Indoor hospital environments are complex, and patients with various health conditions can spend extended periods of time in wards. A number of studies have reported an association of air pollution exposure and a disturbance to sleep. A lack of sleep, or poor and disrupted sleep can impact health. Disturbed sleep therefore can impact a patient's recovery in hospital wards. In addition to the exposure to air pollutants, noise and light levels within the hospital environment can also have an impact on patient health. Inadequate, or a disrupted light and dark cycles can impact the circadian rhythm of the human body, responsible for the sleep cycle. In this study, the investigators aim to characterise these exposures and address the impact of these exposures on the patient sleep. Given the links between sleep and the environmental conditions.",[128,129,130,131,132],"Environment","Sleep","Noise Exposure","Air Quality","Light",[134,135,132,129],"Air quality","Noise","2026-06-04",{"date":138,"type":47},"2026-06-08",{"date":140,"type":47},"2025-04-08",{"date":142,"type":22},"2026-12",{"name":53,"class":54},{"id":145,"slug":146,"hasResults":12,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":23,"phases":154,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},"100413408","phase-2-a-study-of-the-safety-and-activity-of-sparsentan-for-the-treatment-of-patients-with-immunoglobulin-a-nephropathy-100413408","NCT04663204","A Study of the Safety and Activity of Sparsentan for the Treatment of Patients With Immunoglobulin A Nephropathy","A Multi-centre, Open-label, Exploratory Trial of the Safety and Activity of Sparsentan for the Treatment of Incident (Cohort A) and Recurrent (Cohort B) Patients With Immunoglobulin A Nephropathy","SPARTAN","For Cohort A (Patients with Incident IgAN)\n\nInclusion Criteria:\n\n* The patient is willing and able to provide signed informed consent.\n* The patient can understand written and spoken English.\n* The patient is male or female, aged ≥18 years.\n* The patient has been diagnosed with biopsy-proven IgAN within the last 6 months (calculated from the date of kidney biopsy, upon which the IgAN-positive diagnosis was made, to the signing of the informed consent form).\n* The patient has a urine total protein value ≥0.5 g\u002Fday at screening.\n* The patient has an eGFR value ≥30 mL\u002Fmin\u002F1.73 m2 at screening.\n* The patient has not previously been treated with ACEI and\u002For ARB therapy for IgAN OR has not received ACEI and\u002For ARB therapy within the last 12 months.\n* The patient has a systolic BP ≤150 mmHg and ≥100 mmHg, and diastolic blood pressure ≤100 mmHg and ≥60 mmHg at screening.\n* Women of childbearing potential (WOCBP), beginning at menarche, must agree to the use of one highly reliable (ie, can achieve a failure rate of \\\u003C1% per year) method of contraception from 7 days prior to the first dose of trial medication until 90 days after the last dose of trial medication. Highly reliable contraception methods include stable oral, implanted, transdermal, or injected contraceptive hormones associated with inhibition of ovulation, or an intrauterine device (IUD) in place for at least 3 months. One additional barrier method must also be used during sexual activity, such as a diaphragm or diaphragm with spermicide (preferred), or male partner's use of male condom or male condom with spermicide), from Day 1 until 90 days after the last dose of trial medication.\n\nWOCBP are defined as those who are fertile, following menarche and until becoming postmenopausal unless permanently sterile; permanent sterilisation methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as amenorrhoea for more than 24 consecutive months without an alternative medical cause; women on hormone replacement therapy must have a documented plasma follicle-stimulating hormone level ≥40 mIU\u002FmL. All WOCBP must have a negative pregnancy test at Visit 1 (serum test) and Visit 2 (urine, with positive results confirmed by serum).\n\nExclusion Criteria:\n\n* The patient has IgAN secondary to another condition (eg, systemic lupus erythematosus, liver cirrhosis).\n* The patient, in the opinion of the Investigator, has a rapidly progressive glomerulonephritis (rapid decline in GFR and crescents on biopsy).\n* The patient has a history of type 1 diabetes mellitus, uncontrolled type 2 diabetes mellitus (haemoglobin A1c \\[HbA1c\\] \\>8%), or nonfasting blood glucose \\>10 mmol\u002FL (180 mg\u002FdL) at screening.\n* The patient has undergone any organ transplantation, with the exception of corneal transplants.\n* The patient requires any of the prohibited concomitant medications (see Section 14.4).\n* The patient has been taking any systemic immunosuppressive medications for \\>2 weeks within 6 months prior to screening.\n* The patient has a documented history of heart failure (New York Heart Association Class II-IV) and\u002For previous hospitalisation for heart failure or unexplained dyspnoea, orthopnoea, paroxysmal nocturnal dyspnoea, ascites, and\u002For peripheral oedema.\n* The patient has clinically significant cerebrovascular disease (transient ischemic attack or stroke) and\u002For coronary artery disease (hospitalisation for myocardial infarction or unstable angina, new onset of angina with positive functional tests, coronary angiogram revealing stenosis, or a coronary revascularisation procedure) within 6 months prior to screening.\n* The patient has jaundice, hepatitis, or known hepatobiliary disease (including asymptomatic cholelithiasis), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>2 times the upper limit of the normal range at screening.\n* The patient has a history of malignancy other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma within the past 2 years.\n* The patient has a screening haematocrit value \\\u003C27% or haemoglobin value \\\u003C90 g\u002FL (9 g\u002FdL).\n* The patient has a screening potassium value of \\>5.5 mmol\u002FL (5.5 mEq\u002FL).\n* The patient has a history of alcohol or illicit drug use disorder (as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition).\n* The patient has a history of serious side effects or allergic response to any AngII or ERA, including sparsentan, or has a hypersensitivity to any of the excipients in the IMP.\n* The female patient is pregnant, plans to become pregnant during the course of the trial, or is breastfeeding.\n* The patient has participated in a trial of any investigational product within 28 days prior to screening, or plans to participate in such a trial during the course of this trial.\n* The patient, in the opinion of the Investigator, is unable to adhere to the requirements of the trial, including the ability to swallow the IMP whole.\n* The patient, in the opinion of the Investigator, has a medical condition or abnormal clinically significant laboratory screening value not listed above that may interfere with the evaluation of sparsentan safety or activity.\n* Patients with a medical condition or abnormal clinically significant laboratory screening value not listed above that may interfere with the evaluation of sparsentan safety or activity will be reviewed before consideration of the patient for enrolment.\n\nFor Cohort B (Recurrent IgAN following kidney transplantation)\n\nInclusion Criteria:\n\n* Male and female aged ≥18 years\n* Diagnosis of recurrent IgAN based on histological analysis of a transplanted kidney biopsied within the last 6 months\n* A time period of \\>12 months since kidney transplantation\n* UPCR ≥50 mg\u002Fmmol (≥0.44 g\u002Fg) and eGFR value ≥25 mL\u002Fmin\u002F1.73 m2\n* For patients on an ACEI and\u002For ARB, and\u002For SGLT2 inhibitor, the dosing regimen is stable for at least 6 weeks prior to and during the screening period\n* Tacrolimus treatment as part of standard of care immunosuppression following kidney transplantation\n* Systolic BP ≤150 mmHg and ≥100 mmHg, and diastolic blood pressure ≤100 mmHg and ≥60 mmHg at screening.\n* Female patients not of childbearing potential, or of childbearing potential and agreeing to use the contraceptive methods listed in Section 5.1\n\nExclusion Criteria:\n\n* The patient has recurrent IgAN secondary to another condition or cause (eg, systemic lupus erythematosus, liver cirrhosis).\n* Evidence of alternative pathology on the kidney transplant biopsy as the main cause for proteinuria (e.g. diabetic nephropathy, chronic transplant glomerulopathy, mTORi treatment)\n* Patient has multiorgan transplants (with the exception of corneal transplants)\n* Immunosuppressive therapy (IST) regimen for kidney transplant or other chronic immunosuppressive therapies that is not stable for \\>6 weeks prior to Day 1. Exceptions include routine protocol tapering and for tacrolimus, changes in dose to meet target level\n* Treatment with enteric budesonide (nefecon) within 6 months prior to screening, or planned use of enteric budesonide (nefecon) at any time during the study.\n* Current treatment for surgical complications\n* \\\u003C3 months after anti-rejection treatment or active rejection\n* Active bacterial, fungal or viral infection and\u002For active treatment of infection including BKV, CMV, HIV, Hepatitis B and C \\\u003C3 months prior to and during the screening period\n* Current treatment for surgical complications\n* Uncontrolled diabetes mellitus (defined by HbA1C \\>8% (\\>64 mmol\u002Fmol)\n* History of heart failure (New York Heart Association (NYHA) Class II-IV)\n* Jaundice, hepatitis, or known hepatobiliary disease\n* Malignancy within the past 2 years with the exception of adequately treated basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin, with no evidence or recurrence\n* Haematocrit \\\u003C27%, haemoglobin \\\u003C90 g\u002FL (9 g\u002FdL), or potassium \\>5.5 mmol\u002FL (5.5 mEq\u002FL)\n* History of alcohol or illicit drug use disorder (as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition)\n* History of serious side effects or allergic response to any angiotensin II antagonist or endothelin receptor antagonist (ERA) or dual endothelin and angiotensin receptor antagonist (DEARA e.g. sparsentan)\n* The female patient is pregnant, plans to become pregnant during the course of the study, or is breastfeeding.\n* The patient has participated in a study of any investigational product within 28 days prior to screening, or plans to participate in such a study during the course of this study.\n* The patient, in the opinion of the Investigator, is unable to adhere to the requirements of the study, including the ability to swallow the IMP whole.\n* The patient, in the opinion of the Investigator, has a medical condition or abnormal clinically significant laboratory screening value not listed above that may interfere with the evaluation of sparsentan safety or activity.",{"count":153,"type":22},24,[25],"To determine the nephroprotective potential of treatment with sparsentan in (1: Cohort A) patients newly-diagnosed with immunoglobulin A nephropathy (IgAN) (ie, incident patients) who have not received prior angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) therapy, and in (2: Cohort B) patients with recurrent IgAN following kidney transplantation.",[157,158,159,160,161,162],"Immunoglobulin A Nephropathy","Kidney Diseases","Glomerulonephritis, IGA","Glomerulonephritis","Autoimmune Diseases","Immune System Diseases","2026-05-29",{"date":165,"type":47},"2026-06-03",{"date":167,"type":47},"2020-12-10",{"date":169,"type":22},"2027-12-31",{"name":53,"class":54},6,{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":12,"sex":180,"minAge":19,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":23,"phases":182,"briefSummary":183,"conditions":184,"keywords":186,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":197,"locationsCount":88},"100589534","exercise-support-and-rehabilitation-for-patients-after-spontaneous-coronary-artery-dissection-100589534","NCT06955663","Exercise Support and Rehabilitation for Patients After Spontaneous Coronary Artery Dissection","Exercise Support and Rehabilitation for Patients After Spontaneous Coronary Artery Dissection- a Feasibility Study","EXERCISE-SCAD","Inclusion Criteria:\n\n* Female\n* Aged ≥18 years.\n* Diagnosed with angiographically confirmed SCAD and referred to the Leicester SCAD clinic.\n* Ejection fraction \\>45%.\n* Blood pressure \\\u003C180\u002F100. Resting heart rate \\\u003C100bpm\n\nExclusion Criteria:\n\n* No SCAD diagnosis.\n* Unable to travel to Leicester Hospital for their SCAD clinic appointment.\n* Unable to give informed consent.\n* No smart phone or internet access\n* Unable to understand verbal explanations in English.","FEMALE",{"count":125,"type":22},[68],"The study aims to examine the feasibility of a remote exercise program in women recovering from spontaneous coronary artery dissection (SCAD) events (heart attacks). Heart attacks caused by SCAD are different to the traditional heart attacks. In SCAD a tear happens within the blood vessels causing partial or full blockage. The population affected by SCAD is hugely different to the population affected by other 'traditional' heart attacks; as SCAD mainly happens in otherwise healthy women. From historical cases, SCAD has been associated with strenuous exercise, however, medical research did not find a link. The recovery after SCAD is also very different from other 'traditional' heart attacks. Cardiac rehab programmes are designed for an older population therefore they may not be suitable for a younger predominantly female population. This study will examine if a remote-exercise programme is achievable in people after a SCAD event.",[185],"Spontaneous Coronary Artery Dissection",[187,72,188,189,190],"Sponaneous coronary artery dissection","Randomised controlled trial","Rehabilitaiton","Fesability","2026-05-11",{"date":193,"type":47},"2026-05-14",{"date":195,"type":47},"2025-05-01",{"date":169,"type":22},{"name":53,"class":54},{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":99,"phases":4,"briefSummary":207,"conditions":208,"keywords":210,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":88},"100575142","the-role-of-epicardial-adiposity-in-heart-failure-with-preserved-ejection-fraction-100575142","NCT06768437","The Role of Epicardial Adiposity in Heart Failure With Preserved Ejection Fraction","EAT HFpEF","Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the study.\n* Aged ≥18 years old\n* Diagnosed with HFpEF by an experienced cardiologist or signs and symptoms of heart failure with a HFA-PEFF score ≥5\n* Able to understand written English\n\nExclusion Criteria:\n\n* LV ejection fraction \\\u003C45%\n* Recovered ejection fraction (previous ejection fraction \\\u003C40%) unless reduced ejection fraction was in context of tachycardia induced cardiomyopathy (eg atrial fibrillation\u002Fatrial flutter)\n* Severe primary valvular heart disease\n* HFpEF due to infiltrative cardiomyopathy (cardiac amyloidosis or sarcoidosis), genetic hypertrophic cardiomyopathy, restrictive cardiomyopathy\u002Fpericardial disease or congenital heart disease\n* Known heritable, idiopathic or drug-induced pulmonary arterial hypertension\n* Absolute contraindications to cardiac CT or MRI including estimated glomerular filtration rate (eGFR) ≤30ml\u002Fmin\u002F1.73m2. Patients with MRI-compatible devices are be excluded.\n* Women who are pregnant",{"count":206,"type":22},130,"In this study the investigators are aiming to recruit 130 patients with heart failure with preserved ejection fraction who are obese and non-obese to undergo CT and MRI scans, as well as some other investigations including blood tests, to help investigate if having more fat around the heart leads to worse heart function in this condition. This may lead to the development of new treatments aimed at lowering fat levels around the heart and in the rest of the body, specifically to treat HFpEF.",[209],"Heart Failure With Preserved Ejection Fraction (HFPEF)",[211,35,212,213],"Heart failure","Epicardial adipose tissue","Adiposity","2026-04-29",{"date":216,"type":47},"2026-04-30",{"date":218,"type":47},"2025-02-12",{"date":220,"type":22},"2037-08",{"name":53,"class":54},{"id":223,"slug":224,"hasResults":12,"nctId":225,"briefTitle":226,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":229,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":99,"phases":4,"briefSummary":231,"conditions":232,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":234,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":88},"100566252","manganese-enhanced-magnetic-resonance-imaging-memri-in-heart-failure-with-preserved-ejection-fraction-100566252","NCT06652763","Manganese-enhanced Magnetic Resonance Imaging (MEMRI) in Heart Failure With Preserved Ejection Fraction","MEMRI in HFpEF","Inclusion Criteria:\n\n* Capacity to provide informed consent\n* Symptoms (e.g. breathlessness, orthopnoea, ankle swelling, fatigue), signs (e.g. elevated jugular venous pressure, peripheral oedema, third heart sound) or established diagnosis of HF with LV ejection fraction ≥ 50%, or\n* Meets HFpEF diagnostic criteria in accordance with the HFA-PEFF diagnostic algorithm form the Heart Failure Association of the European Society of Cardiology, in which a score ≥5 points confirms diagnosis of HFpEF\n\nExclusion Criteria:\n\n* Known diagnosis of Type 1 Diabetes\n* Pregnancy or breast-feeding or females of child bearing age without a negative pregnancy test\n* Receiving an investigational drug or device within 30 days prior to participating in the study\n* Decompensated heart failure or pulmonary oedema\n* History of prolonged corrected QT interval or torsades de pointes\n* Second- or third-degree atrioventricular block\n* Abnormal liver function tests (\\> 3x upper limit of normal) or history of liver disease\n* Baseline eGFR \\\u003C 30mL\u002Fmin\u002F1.73m2\n* Any contraindications to MRI including implanted devices\u002Fpacemakers\n* Severe native valve disease, restrictive cardiomyopathy, constrictive pericarditis or hypertrophic cardiomyopathy, myocarditis or takotsubo cardiomyopathy.\n* Recent myocardial infarction within the previous 3 months\n* Known diagnosis of pheochromocytoma",true,{"count":66,"type":22},"Heart failure with preserved ejection fraction (HFpEF) is a condition in which the heart cannot fill with blood effectively. As a result, people with HFpEF suffer fatigue, breathlessness, and develop swollen limbs. The condition often requires multiple admissions to hospital and is associated with a marked loss of lifespan.\n\nDespite being so common, very little is known about why people develop HFpEF and there are hardly any known treatments. Type 2 diabetes (T2D) is a major risk factor for HFpEF, and people with both HFpEF and diabetes are at a heightened risk of hospitalisation and premature death. It is unclear why the combination of diabetes and HFpEF is particularly harmful. This may be related to the hearts of people with type 2 diabetes being unable to take up the mineral calcium properly, as well as due to their hearts being less energy efficient. Both of these are vital to heart muscle pumping and filling, but until recently it has not been possible to assess these in humans.\n\nNew advances in heart MRI scans, with dedicated scanner techniques and dyes (manganese contrast), now allow extremely detailed pictures of heart structure, function, calcium uptake and energy efficiency, all during the same scan. The investigators will enlist 40 volunteers with HFpEF (20 with T2D and 20 without T2D), and up to 20 healthy volunteers, to undergo a heart MRI scan with manganese contrast to assess calcium uptake and energy efficiency. This will allow the comparison of people with HFpEF with and without T2D, to see how their hearts are different to healthy volunteers.",[29,233],"Type 2 Diabetes",{"date":216,"type":47},{"date":236,"type":47},"2024-10-10",{"date":238,"type":22},"2036-02",{"name":53,"class":54},{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":99,"phases":4,"briefSummary":249,"conditions":250,"keywords":252,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":256,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":260,"locationsCount":88},"100521520","non-invasive-diagnosis-of-coronary-microvascular-disease-pilot-study-100521520","NCT06070662","Non-invasive Diagnosis of Coronary Microvascular Disease: Pilot Study","Non-invasive Diagnosis of Coronary Microvascular Disease Using Novel CMR and CT Techniques: a Pilot Study","Inclusion Criteria:\n\n* Current participant of the 'CMR versus CT-FFR in CAD' study\n* Continue to meet the inclusion criteria for the main study:\n* Patients aged ≥18 years\n* Referred for invasive coronary angiography for investigation of chest pain\n* Willing and able to give informed consent\n* Willing and able (in the Investigators opinion) to comply with all study requirements.\n* Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.\n* Able to understand written English\n* Able to perform exercise in the MRI scanner\n\nStudy arm:\n\n* No evidence of obstructive or non-obstructive CAD on research CTCA\n* Myocardial perfusion defect detected on adenosine stress CMR indicative of CMD\n\nControl arm:\n\n• Evidence of multivessel CAD on research CTCA\n\nExclusion Criteria:\n\n* Meet the exclusion criteria for the main study:\n* Recent acute coronary syndrome (\\\u003C 6 months)\n* Severe claustrophobia\n* Absolute contraindications to CMR - those with MR conditional or safe devices will be included\n* Second-\u002Fthird-degree atrioventricular block\n* Severe chronic obstructive pulmonary disease\n* Moderate-severe asthma\n* Estimated glomerular filtration rate \\\u003C30 ml\u002Fmin\u002F1.73m2\n* Women who are pregnant, breast-feeding or of child-bearing potential (premenopausal women)\n* Contraindication to iodinated contrast\n* Participants who have participated in a research study involving an investigational product in the past 12 weeks\n* Patients unable to understand written English",{"count":248,"type":22},20,"* 40% of patients presenting with stable chest pain (angina) have no significant blockage of the main heart arteries. Identifying why these patients have symptoms will mean better treatment options can be developed.\n* About 60% of these patients have evidence of coronary microvascular disease (CMD). In this condition there is a problem with the heart's microvessels (very small blood vessels that branch from the main heart arteries). Due to problems with these vessels there is a mismatch between the blood supply to the heart and its oxygen consumption, causing chest pain and this can also lead to major heart events.\n* At present, to diagnose this condition, specialised techniques during an invasive test, called a coronary angiogram, are required. As this is an invasive test, it can be lead to complications and cause discomfort.\n* Non-invasive ways of diagnosing CMD are required to improve the diagnosis and management of this condition.\n* This study aims to provide initial data on whether novel imaging techniques using CT and MRI scans, which are much less invasive, could identify CMD.\n* To do this, patients with suspected angina referred for angiography and who are already participants in the main research study 'CMR versus CT-FFR in CAD' study will be recruited.\n* These will be patients with suspected CMD and also those with blockage of the main heart arteries (triple vessel disease) to compare against.\n* Participants in this pilot study will have additional tests used to diagnose CMD during their invasive angiography procedure. Participants will then have an MRI scan involving novel techniques and exercise MRI, where individuals exercise use a cycle or stepping machine during the MRI scan. Further analysis will also be undertaken of CT images acquired as part of the main study.\n* These tests will be compared against invasive test results to see which show potential in being able to diagnose CMD.",[251],"Microvascular Angina",[253,254,255],"Coronary microvascular disease","Angina","Non-invasive testing",{"date":216,"type":47},{"date":258,"type":47},"2023-11-01",{"date":142,"type":22},{"name":53,"class":54},{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":268,"targetDuration":4,"studyType":23,"phases":270,"briefSummary":271,"conditions":272,"keywords":274,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":88},"100515064","brain-training-to-improve-balance-in-parkinsons-disease-100515064","NCT05986643","Brain Training to Improve Balance in Parkinson's Disease","Using Biofeedback During Exergaming to Attenuate Alpha Oscillations to Improve Postural Control in People Living With Parkinson's.","Inclusion Criteria:\n\nPeople with Parkinson with mild-moderate disease and severe disability (but able to stand and walk unaided (Hoehn and Yahr stage ≤4) be eligible if:\n\n* in everyday life, they do less than the recommended aerobic exercise for older adults (i.e., vigorous exercise done \\\u003C3 times per week, 20 min per session; or moderate exercise done \\\u003C5 times per week, 30 min per session).\n* they have experienced at least one fall and one episode of freezing of gait in the past year.\n* they are taking stable dopaminergic pharmacotherapy (stable dose for at least 1 month) or are still without treatment and not expected to start treatment within the next 3 months.\n\nAs long as all criteria are met - we will not impose any lower (assuming they are adults) or upper age limit for recruitment.\n\nExclusion Criteria:\n\n* severe lower limb motor impairments and\u002For requirement of a walking aid or wheelchair\n* previously diagnosed with stroke or dementia\n* having metal implants in the head (i.e. deep brain stimulator or aneurysm clips)\n* any other known medical, mental health, or physical condition which may interfere with balance.\n* patients on beta-blocking agents or antipsychotics\n* patients with other neurological, orthopaedic, or cardiac co-morbidities that make them unfit to do exercise or interferes with balance and cognitive functions required to participate in this study\n* patients with psychiatric diseases diagnosed in the past year by a psychiatrist\n* patients with dementia\n* those unable to tolerate the exergame task.",{"count":269,"type":22},100,[68],"People living with Parkinson's (PwP) rank balance problems amongst the most disabling symptom. Over time, balance function continues to decline and PwP go on to fall, affecting between 45-68% of PwP. Falling directly impacts upon the individuals' quality of life (QoL), as it prevents patients from doing everyday activities, and places PwP at greater risk of other medical problems, such as fractures.\n\nNew treatments are urgently needed to improve balance and reduce falls in order to improve QoL for PwP. The aim of this project is to achieve these goals by using exercise to alter brain activity. Supporting our idea, are previous studies that show both exercise alone as well as changing brain activity at rest via visual feedback (similar to how breathing can be controlled to lower blood pressure), can be used to rehabilitate balance. Here researchers test the idea that better results can be achieved for PwP, if a specific exercise program is used as the feedback to change brain activity.\n\nPwP will be assigned randomly into 2 groups, one receiving the exergaming physical therapy (PT) alone with a placebo feedback and, the second group will be required to change brain activity using exercise feedback to change brain activity.\n\nEach intervention will be performed 3 times\u002Fweek with each session lasting 1⁄2 an hour, for 12 consecutive weeks. Participants are expected to attend 5 sessions over each fortnight. Assessments of balance will be made before and after all three treatments. This will allow us to measure any improvements and compare the 2 different methods to see which one improves balance the most in PwP.",[273],"Parkinson Disease",[275,276],"Balance","Gait","2026-04-27",{"date":279,"type":47},"2026-04-28",{"date":281,"type":47},"2023-08-04",{"date":283,"type":22},"2027-05",{"name":53,"class":54},{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":291,"eligibilityCriteria":292,"healthyVolunteers":229,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":23,"phases":295,"briefSummary":296,"conditions":297,"keywords":301,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":4},"100631459","effectiveness-of-pollution-monitoring-in-clinical-exercise-rehabilitation-100631459","NCT07500948","Effectiveness of Pollution Monitoring in Clinical Exercise Rehabilitation","Effectiveness of Pollution Monitoring in Clinical Exercise Rehabilitation (EPIC-AIR)","EPIC-AIR","Inclusion Criteria:\n\n* Cohort A: Patients with long-term conditions Inclusion criteria for Cohort A are: male or female adults aged ≥18 years; clinical diagnosis of one or more of asthma, COPD, interstitial lung disease (ILD), coronary heart disease (CHD), or heart failure (HF), and signed off for exercise rehabilitation by a clinician; ownership of a GPS-enabled smartphone with internet access; ability to walk outdoors for a minimum of 5 minutes without feeling uneasy or unsteady; availability to complete the 13-week intervention within the recruitment window (February-May 2026); willingness and ability to give informed consent; and willingness to wear a Fitbit device for \\>70% of the study duration.\n* Inclusion criteria for Cohort B are identical to Cohort A, with the exception that participants must have no diagnosis of asthma, COPD, ILD, CHD, or HF.\n\nExclusion Criteria:\n\n* Exclusion criteria for both cohorts are: diagnosis of dementia, learning disability, severe mental health disorders (excluding depression or anxiety), or epilepsy; receiving palliative care; insufficient English language ability to understand study documentation and use the platform; having been advised not to exercise by a healthcare professional within the past 12 months; currently pregnant; presence of chest pain at rest; and marked unsteadiness when standing or walking.",{"count":294,"type":22},80,[68],"The primary objective of EPIC-AIR is to evaluate the feasibility and potential effectiveness of integrating real-time air pollution monitoring into CR and PR programmes via an online platform that delivers both exercise prescription and air pollution guidance. Specific objectives are: (1) to determine whether access to real-time air quality data reduces personal pollution exposure (PM2.5, PM10, NO2) during outdoor physical activity in CR\u002FPR patients and healthy volunteers; (2) to evaluate the usability and acceptability of the platform in a clinical rehabilitation context; (3) to assess the feasibility of the trial design, including recruitment, randomisation, retention, and adherence rates; (4) to measure the impact of the intervention on physical activity levels, health-related quality of life, and cardiovascular biomarkers; and (5) to inform the design and sample size of a future definitive randomised controlled trial.",[298,299,300],"Cardiovascular Disease","Asthma","COPD",[302,303,77],"air pollution","cardiac rehabilitation","2026-03-24",{"date":306,"type":47},"2026-03-30",{"date":308,"type":22},"2026-05",{"date":310,"type":22},"2027-03-01",{"name":53,"class":54},{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":229,"sex":18,"minAge":320,"maxAge":4,"enrollmentInfo":321,"targetDuration":4,"studyType":99,"phases":4,"briefSummary":323,"conditions":324,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":338},"100489183","vascular-mechanisms-in-stroke-depression-dementia-and-delirum-the-vespar-project-100489183","NCT05649800","Vascular mEchanisms in, Stroke, dePression, dementiA, and deliRum: The VESPAR Project","Evaluating the Feasibility of Remote Haemodynamic Monitoring in a Cohort of Multi-ethnic Chronic Stroke Patients Using a Novel User Interface and Artificial Intelligence Algorithms","VESPAR","* Inclusion Criteria:\n* Healthy adults aged over 65 years, free from medical comorbidities or medications that can adversely affect cognitive function or cerebral haemodynamics;\n* Stable, well controlled comorbidities (e.g. hypertension);\n* A diagnosis of dementia (major neurocognitive disorder), depression, or delirium, according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria;\n* Participants on or off anti-dementia drug therapy (acetylcholinesterase inhibitors, NMDA receptor antagonists), and antidepressants;\n* A diagnosis of ischaemic (IS) or haemorrhagic (ICH) stroke according to clinical and\u002For radiological findings, within 72 hours of symptom onset\n* Exclusion Criteria:\n* Poorly controlled medical comorbidities affecting cerebral haemodynamics or cognitive function (e.g., heart failure, hypertension, type two diabetes);\n* Clinically unstable or too unwell to cooperate with the study protocol;\n* Lacks capacity or personal consultee to consent to the study.","65 Years",{"count":322,"type":22},140,"The goal of this observational study is to determine the feasibility of using integrated Transcranial Doppler Ultrasonography or Near Infrared Spectroscopy to detect changes in cerebral autoregulation and neurovascular coupling in healthy, stroke, dementia, depression and delirium populations. We also aim to:\n\n* Determine the optimal stimulus for neurovascular coupling\n* To derive sample size estimates for a future study\n* To develop a multilevel, multivariate model that can be applied to future datasets",[325,326,327,328,329],"Cognitive Dysfunction","Stroke","Dementia","Depression","Delirium","2025-11-28",{"date":332,"type":47},"2025-12-01",{"date":334,"type":47},"2023-03-17",{"date":336,"type":22},"2026-08-26",{"name":53,"class":54},2,{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":345,"eligibilityCriteria":346,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":347,"targetDuration":4,"studyType":23,"phases":349,"briefSummary":350,"conditions":351,"keywords":353,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":367},"100378235","the-early-valve-replacement-in-severe-asymptomatic-aortic-stenosis-study-100378235","NCT04204915","The Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis Study","A Randomised Controlled Trial of Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis","EASY-AS","Inclusion Criteria:\n\n1. Age \\>18 years\n2. Patient has severe asymptomatic AS, in line with current international guidelines, defined as either:\n\n   1. Peak velocity ≥4m\u002Fs OR mean pressure gradient ≥40mmHg WITH aortic valve area ≤1.0cm2 OR ≤0.6cm2\u002Fm2 body surface area OR\n   2. Peak velocity ≥4m\u002Fs OR mean pressure gradient ≥40mmHg WITH aortic valve area \\>1.0 - ≤1.2cm2 OR \\>0.6 - ≤0.7cm2\u002Fm2 body surface area AND high sex specific calcium score\\* OR\n   3. Peak Velocity ≥3.5m\u002Fs - 3.9m\u002Fs AND mean pressure gradient \\\u003C40 mmHg WITH aortic valve area ≤1.0cm2 OR ≤0.6cm2\u002Fm2 body surface area AND high sex specific calcium score\\* \\*Sex specific high calcium scores (Agatston units): \\>1200 females; \\>2000 males\n3. The responsible clinician feels that either ongoing surveillance or early AVR are appropriate.\n4. Regarded by the treating cardiologist to be suitable for AVR (surgical or TAVI) with an acceptable risk\n5. Willing to provide informed consent and be randomised to early AVR or expectant management\n6. An ability to understand one of the written languages that the study has provided written and visual materials in, or the availability of a translator to explain the study documentation\n\n   Exclusion Criteria:\n7. Symptoms related to AS\n8. Additional severe valvular heart disease\n9. Other cardiac surgery planned pre-randomisation (eg CABG)\n10. Left ventricular systolic dysfunction (LVEF \\\u003C50%)\n11. Pregnancy\n12. Co-morbid condition that, in the opinion of the treating cardiologist, limits life expectancy to \\\u003C2 years\n13. Patient has previously undergone AVR or TAVI with restenosis",{"count":348,"type":22},2844,[68],"Aortic stenosis (AS) affects approximately 5% of individuals \\>65 years old, with \\~3% of people \\>75 years having moderate to severe disease. The prevalence of AS is rising rapidly due to an ageing population and is projected to double in the next two decades. Increasingly clinicians face the dilemma of how to best manage this growing population of mainly elderly patients, many of whom are asymptomatic but have been identified as having severe AS, often as an incidental finding. Reduced aortic valve opening progresses over decades without any apparent symptoms because the heart compensates for the AS. Ultimately, compensatory mechanisms fail resulting in angina, syncope or heart failure. If these symptomatic patients with severe AS remain untreated, they have a dire prognosis. In this situation the only effective treatment is AVR, either surgically or using TAVI. Conversely, conventional teaching and clinical practice in cardiology has been that, in the absence of symptoms, the prognosis is usually excellent and, except in a few very specific circumstances, conservative management and regular review (expectant management) is recommended. This advice is reflected in current international guidelines but is based largely on historical precedent. There has never been a randomised controlled trial to address the relative benefits of early AVR versus expectant management in patients with severe asymptomatic AS. The relative benefits of a strategy of early AVR\u002FTAVI versus expectant management in patients with asymptomatic severe AS are unclear. There is clinical equipoise but it remains one of the few areas of cardiovascular medicine where no randomised controlled trials (RCT) have been performed. The EASY-AS study will provide crucial data on the relative merits of these differing approaches to management, in terms of important patient orientated outcomes, conventional cardiovascular end-points and cost effectiveness.",[352],"Aortic Stenosis",[354,355,188,356,357,358],"Asymptomatic aortic stenosis","Aortic valve replacement","Expectant management","Hospitalisation for heart failure","Cardiovascular death","2025-09-24",{"date":361,"type":47},"2025-09-25",{"date":363,"type":47},"2020-03-10",{"date":365,"type":22},"2031-04-01",{"name":53,"class":54},110,{"id":369,"slug":370,"hasResults":12,"nctId":371,"briefTitle":372,"officialTitle":372,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":374,"targetDuration":4,"studyType":99,"phases":4,"briefSummary":376,"conditions":377,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":384,"locationsCount":4},"100608436","disease-modification-outcomes-in-diabetes-a-delphi-study-100608436","NCT07201532","Disease Modification Outcomes in Diabetes: a Delphi Study","Inclusion Criteria:\n\nParticipants will fall into one of two groups:\n\n1. Healthcare practitioners and researchers working in the field of diabetes research and\u002For clinical care.\n2. People with type 2 diabetes. All participants will be ≥18 years of age.\n\nExclusion Criteria:\n\n1. Potential participants who are not willing to provide informed consent or participate in the Delphi study.\n2. Those who are unable to understand English.\n3. Those without the capability to respond to the online survey.",{"count":375,"type":22},300,"Type 2 diabetes is a condition when the pancreas does not produce enough of the hormone, insulin, or the insulin that is formed does not function effectively. This results in high blood sugar levels. Type 2 diabetes is associated with other health conditions, and people with the condition have a higher chance of dying earlier and having other complications. People with type 2 diabetes take a lot of different types of medications. The current treatments that exist aim to manage blood sugar levels, rather than affect the progression of the disease.\n\nThe research involving treatments that impact the long-term progression of type 2 diabetes is sometimes hard to understand. This is because research studies measure a lot of different outcomes (outcomes are items we measure to show that the study has worked and\u002For it is safe). One way of improving research is to make sure that we are measuring the same outcomes, but also that these outcomes are important to people living with type 2 diabetes and healthcare professionals. This can be done by using a core outcome set (COS). A COS is a short list of outcomes that are important to researchers, healthcare professionals and people living with type 2 diabetes. The aim of this study is to design a COS for research studies for disease modification in type 2 diabetes via an e-Delphi study.\n\nThe Delphi process is a structured process used for forming a consensus, where stakeholder groups provider their opinions in an iterative approach for answering questions over several rounds. This will also take place using surveys online.",[233],"2025-09-23",{"date":380,"type":47},"2025-10-01",{"date":382,"type":22},"2025-09",{"date":51,"type":22},{"name":53,"class":54},{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":391,"eligibilityCriteria":392,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":393,"targetDuration":4,"studyType":99,"phases":4,"briefSummary":394,"conditions":395,"keywords":397,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":408,"locationsCount":88},"100420993","cmr-versus-ct-in-coronary-artery-disease-100420993","NCT04761991","CMR Versus CT in Coronary Artery Disease","Comparison of Cardiovascular Magnetic Resonance and Computed Tomography With Fractional Flow Reserve in the Diagnosis of Suspected Coronary Artery Disease","CONCORD","Inclusion Criteria:\n\n* Patients aged ≥18 years\n* Referred for invasive coronary angiography for investigation of chest pain\n\nExclusion Criteria:\n\n* Recent acute coronary syndrome (\\\u003C 6 months)\n* Previous coronary artery bypass grafting\n* Severe claustrophobia\n* Absolute contraindications to CMR - those with MR conditional or safe devices will be included\n* Second-\u002Fthird-degree atrioventricular block\n* Severe chronic obstructive pulmonary disease\n* Moderate-severe asthma\n* Estimated glomerular filtration rate \\\u003C30 ml\u002Fmin\u002F1.73m2\n* Women who are pregnant, breast-feeding or of child-bearing potential( premenopausal women)\n* Contraindication to iodinated contrast\n* Participation in a research study involving an investigational product in the past 12 weeks",{"count":375,"type":22},"CONCORD is a prospective observational study evaluating the diagnostic accuracy of cardiovascular magnetic resonance (CMR) and computed tomography with fractional flow reserve (CT-FFR) in patients with suspected coronary artery disease, using invasive fractional flow reserve (FFR) as the reference standard.",[396],"Coronary Artery Disease",[398,399,400],"MRI","CT-FFR","coronary artery disease","2025-06-26",{"date":403,"type":47},"2025-07-01",{"date":405,"type":47},"2020-11-05",{"date":407,"type":22},"2025-11-30",{"name":53,"class":54},{"id":410,"slug":411,"hasResults":12,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":415,"eligibilityCriteria":416,"healthyVolunteers":229,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":417,"targetDuration":4,"studyType":99,"phases":4,"briefSummary":418,"conditions":419,"keywords":425,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":88},"100594064","using-heart-electrical-signals-to-study-how-well-treatments-prevent-dangerous-heart-rhythms-in-active-people-100594064","NCT07014579","Using Heart Electrical Signals to Study How Well Treatments Prevent Dangerous Heart Rhythms in Active People","Utilizing LifeMap To Investigate Malignant Arrhythmia Therapeutic Efficacy in Athletes","ULTIMATE-A","Inclusion Criteria:\n\n* Age 18 and over.\n* Participates in regular physical activity for at least 3 hours or greater weekly.\n* Having Implantable cardioverter defibrillator insitu (cases).\n* Having a cardiac pacemaker (control).\n* Having no cardiac device (control).\n* Sufficient capacity and agreement to participate orally and signed written consent forms.\n* Understanding of written and spoken English language.\n\nExclusion Criteria:\n\n* Pregnancy, as detected by positive urine pregnancy test result.\n* Inability to comply with study protocols.\n* Any iatrogenic cardiac pathology (stents, CABG etc).\n* Unstable ventricular tachycardia (\\>30 seconds).\n* Any unstable malignant arrhythmia.\n* Fever or presence of a clinically diagnosed febrile illness",{"count":98,"type":22},"The goal of this observational study is to learn if two specific heart electrical signal patterns can help in detecting the risk of dangerous heart rhythms in athletes, and to see if exercise-based tests can be used instead of invasive hospital procedures to record this electrical signals.\n\nThe main questions it aims to answer are:\n\n1. Can special ECG action potential duration markers (R2I2 and PERS) identify athletes who are at higher risk of sudden heart rhythm problems.\n2. Can an exercise test give the same information as a non-invasive electrophysiology study.\n\nResearchers will compare athletes who have an implanted heart device (ICD) with athletes who do not, to see if there are differences in these heart signals.\n\nParticipants will undergo:\n\n1. ECG recordings during rest and exercise.\n2. If they have an ICD or pacemaker, an ECG will be recorded during a non invasive stimulation.\n3. A continuous 24 hour ECG.",[420,421,422,423,424],"Inherited Cardiac Conditions","Sudden Cardiac Arrest","Ventricular Arrhythmia","Athlete","Ventricular Fibrillation",[426,427,428,429,422,424,430],"ULTIMATE-Athlete","LifeMap","R2I2","PERS","Sudden Cardiac Death","2025-06-09",{"date":433,"type":47},"2025-06-11",{"date":435,"type":22},"2025-06-01",{"date":437,"type":22},"2026-07-31",{"name":53,"class":54},{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":99,"phases":4,"briefSummary":449,"conditions":450,"keywords":453,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":459,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":88},"100330767","validating-novel-non-contrast-cardiac-mri-imaging-in-haemodialysis-patients-100330767","NCT03586518","Validating Novel, Non-contrast Cardiac MRI Imaging in Haemodialysis Patients","Validating the Accuracy of Novel, Non-contrast, Cardiac Magnetic resOnaNce Imaging in Defining Myocardial FIbRosis in Patients With End-stage Renal Disease on haeModialysis: the CONFIRM Study","CONFIRM","Inclusion Criteria:\n\n* Prevalent haemodialysis patient (more than 3 months)\n* Active on the supportive care register with anticipated death in the subsequent 12 months\n* Able to give informed consent\n* Consent to donation of heart for research following death\n* Able to understand written and verbal explanations in English\n\nExclusion Criteria:\n\n* Contraindication to MRI scan (e.g. pacemaker, incompatible metallic implants, claustrophobia)\n* Patients with expected or potential infiltrative cardiomyopathy (e.g. amyloidosis)\n* Unable to give informed consent\n* Unable to understand written and verbal explanations in English",{"count":448,"type":22},9,"There are currently no good ways of measuring levels of scarring in the hearts of patients with advanced kidney disease and patients on dialysis, although recent research has shown a new cardiac MRI technique, called native T1 mapping, may provide a solution to this. To assess the accuracy of this novel technique in dialysis patients, it is essential to undertake a study which compares native T1 mapping to actual levels of scarring in the hearts of patients on dialysis.",[451,452],"End Stage Kidney Disease","Fibrosis Myocardial",[454,455,456,457],"Cardiac MRI","Hemodialysis","Myocardial Fibrosis","Myocardial Inflammation","2025-04-15",{"date":460,"type":47},"2025-04-18",{"date":462,"type":47},"2019-11-03",{"date":464,"type":22},"2025-12-31",{"name":53,"class":54},{"id":467,"slug":468,"hasResults":12,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":472,"eligibilityCriteria":473,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":23,"phases":476,"briefSummary":477,"conditions":478,"keywords":482,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":489,"lastUpdatePostDateStruct":490,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":338},"100564476","make-every-step-count-personalised-music-feedback-to-walking-for-people-living-with-copd-100564476","NCT06629675","Make Every Step Count: Personalised Music Feedback to Walking for People Living With COPD","Personalised Music Feedback to Optimise Adherence to the Walking Exercise Prescription During Pulmonary Rehabilitation for Individuals Living With Chronic Obstructive Pulmonary Disease","MuSiC","Inclusion Criteria:\n\n* Willing and able to provide informed consent for participation in the study.\n* The patient is referred for PR at the UHL.\n* The patient has a confirmed diagnosis of COPD using spirometry (based on GOLD criteria)\n* Male or female, aged 18+ years.\n* Able to communicate in written and spoken English.\n\nExclusion Criteria:\n\n* Unable to provide valid informed consent.\n* Lack of motivation to participate in PR programme.\n* Any-contra-indications absolute or relative to exercise training.\n* Has had a cardiac event within last 6 weeks\n* Severe psychiatric disorders\n* Patients with a history of MRSA +ve screens (patients can be assessed and given an exercise programme but cannot attend the classes. Patients need to have 3 consecutive -ve MRSA swabs before they can attend).\n* Unable to understand written or spoken English.",{"count":475,"type":22},30,[68],"Pulmonary Rehabilitation (PR) is an evidence-based intervention to effectively manage the physiological and psychological effects of Chronic Obstructive Pulmonary Disease (COPD). The aims of PR are to improve symptoms of COPD, increase exercise capacity, increase independency, improve overall behaviour related to health (like exercising more), and enhance quality of life. The cornerstone of PR programmes is aerobic exercise prescription. Typically, walking exercise is used, and the prescription is individualised for each patient based on their maximal walking exercise capacity. However, adherence to walking exercise is challenging for service users, particularly when unsupervised at home. The use of music during exercise shows promise as a tool to decrease the perception of fatigue and increase motivation, but the integration of music via smartphone applications to support walking exercise adherence during PR has not been explored. This project aims to assess if a new mobile application BeatClearWalker (BCW) intervention is practical, acceptable, and effectively used by people living with COPD. The app is designed to help people living with COPD attending PR adhere to their prescribed walking pace during exercise. The BCW app provides real-time, personalised music feedback through music degradation to optimise the dose of walking exercise.",[479,480,481],"Chronic Obstructive Pulmonary Disease (COPD)","Chronic Obstructive Lung Disease","Chronic Obstructive Airway Disease",[483,484,485,72,486,487,488],"Auditory feedback","Chronic Obstructive Pulmonary Diseases","Digital Health Technology","Exercise adherence","Pulmonary rehabilitation","Mobile applications","2025-04-11",{"date":491,"type":47},"2025-04-16",{"date":493,"type":22},"2025-04-20",{"date":495,"type":22},"2025-09-26",{"name":53,"class":54},{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":503,"eligibilityCriteria":504,"healthyVolunteers":229,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":505,"targetDuration":4,"studyType":99,"phases":4,"briefSummary":507,"conditions":508,"keywords":509,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":338},"100559706","decision-support-tool-for-revascularisation-options-in-coronary-artery-disease-100559706","NCT06567626","Decision Support Tool for Revascularisation Options in Coronary Artery Disease","Mixed Methods Co-design and Evaluation of a DECIsion Support Tool to Enable Shared DEcision Making With People Who Are Considering Revascularisation Options for Coronary Artery Disease","DECIDE-CAD","WP1. DST CO-DESIGN PATIENT PARTICIPANTS\n\nInclusion Criteria\n\nParticipants may enter the study if ALL of the following applies:\n\n1. Any adult (≥ 18 years) with lived experience of coronary revascularisation\n2. Willing and able to consent to study participation.\n3. Able to understand written and spoken English for decisional needs workshop or focus groups (NB this criterion is not required for cognitive interviews or acceptability questionnaire)\n\nExclusion Criteria\n\nParticipants may not enter the study if they are unable to provide informed consent. Individuals who participate in focus groups are ineligible for subsequent participation in cognitive interviews and acceptability questionnaires.\n\nWP1. DST CO-DESIGN HCP PARTICIPANTS\n\nInclusion Criteria\n\nParticipants may enter the study if ALL of the following applies:\n\n1. Healthcare professional with a patient-facing clinical role which involves decision making regarding coronary revascularisation\n2. Willing and able to consent to study participation.\n3. Able to understand written and spoken English\n\nExclusion Criteria\n\nParticipants may not enter the study if they are unable to provide informed consent.\n\nWP2. DST FEASIBILITY PATIENT PARTICIPANTS\n\nInclusion Criteria\n\nParticipants may enter the study if ALL of the following applies:\n\n1. Adult (≥ 18 years) awaiting coronary revascularisation\n2. Has received coronary angiography for definitive diagnosis.\n3. Willing and able to consent to study participation.\n4. Able to understand written and spoken English, Polish, Romanian, Urdu, Panjabi, or Gujarati\n\nExclusion Criteria\n\nParticipants may not enter the trial if ANY of the following apply:\n\n1. Where clinical consensus strongly recommends one option of revascularisation over another\n2. Unable to provide informed consent\n3. Unable to speak one of the aforementioned 6 languages\n\nWP2. DST FEASIBILITY HCP PARTICIPANTS\n\nInclusion Criteria\n\nParticipants may enter the study if ALL of the following applies:\n\n1. Healthcare professional with a patient-facing clinical role which involves decision making regarding coronary revascularisation\n2. Willing and able to consent to study participation.\n3. Able to understand written and spoken English\n\nExclusion Criteria\n\nParticipants may not enter the study if they are unable to provide informed consent.",{"count":506,"type":22},126,"Together with patients and healthcare professionals, we want to design a Decision Support Tool (DST) that will help people with coronary artery disease to understand and choose treatments that best reflect their preferences and values.\n\nCoronary artery disease (CAD) is a leading cause of death. Blood vessels supplying oxygen to the heart muscle become narrowed by a gradual build-up of fatty material. This can result in heart attacks, heart failure, and sudden death. One way to treat the blockage is by inserting an inner sleeve called a \"stent\" into the blood vessel and clearing the blockage by forcing it into the artery wall. Another method involves diverting the blood supply around the blockage using a vessel harvested from another body site; this is called \"bypass surgery\". The best treatment, either stents or surgery, is different for everyone.\n\nA Decision Support Tool (DST) will provide key information on the pros and cons of stents or surgery and how these match an individual's preferences and values. People are then empowered to make shared decisions about treatment with their doctors. Personalising treatment decisions in this way can reduce inequalities in care and improve shared decision making. Our proposed research will develop a DST in the form of a webpage with alternative print material for those at risk of digital poverty. The DST will be developed in multiple languages to improve accessibility.\n\nThere are two parts to the study: the first part will use the experience of patients, who have already had stent or surgery, and healthcare professionals to design and refine a DST prototype; this will be done through workshops, focus groups, and cognitive interviews. The second part will test whether it is possible to use the DST by people with CAD waiting for a procedure; this will be done through questionnaires and interviews. The result of this study can then subsequently inform an assessment of the refined DST on a national level, with the hopes of enabling more effective shared decision making.",[396],[510,511,512],"Shared Decision Making","Percutaneous Coronary Intervention (PCI)","Coronary Artery Bypass Grafting (CABG)","2025-03-31",{"date":515,"type":47},"2025-04-03",{"date":517,"type":47},"2024-10-11",{"date":519,"type":22},"2027-09",{"name":53,"class":54},{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":527,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":529,"targetDuration":4,"studyType":23,"phases":530,"briefSummary":531,"conditions":532,"keywords":537,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":542,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":548},"100515793","study-on-optimal-temperature-during-cardiopulmonary-bypass-thermic-4-100515793","NCT05996120","Study on Optimal Temperature During Cardiopulmonary Bypass (THERMIC-4)","Normothermic Versus Hypothermic Cardiopulmonary Bypass in Adult Cardiac Surgery: a Multicentre Feasibility Randomised Controlled Trial","THERMIC-4","INCLUSION CRITERIA\n\nParticipants may enter the trial if all of the following apply\n\n1. Adult patients (≥ 18 years) scheduled for coronary artery bypass surgery and\u002For valve replacement\u002F repair, either in the elective or urgent setting.\n2. European System for Cardiac Operative Risk Evaluation (EuroSCORE) II of 2 or higher.\n3. Able to understand and communicate to provide informed consent.\n4. Able to read and understand the English language.\n\nEXCLUSION CRITERIA\n\nParticipants may not enter the trial if any of the following apply:\n\n1. Patients undergoing coronary artery bypass surgery in combination with other procedures including cardiac or vascular procedures that require deep hypothermic arrest.\n2. Patients undergoing emergency or salvage surgery.\n3. Patients undergoing off-pump cardiac surgery.\n4. Patients who are participating in another interventional trial.\n5. Unable to provide informed consent.",{"count":269,"type":22},[68],"In order to perform heart surgery, a machine called cardiopulmonary bypass (CPB), or more commonly known as a heart-lung machine, is used to maintain the circulation of oxygenated blood needed by the rest of the body and its organs.\n\nHistorically, when a patient is connected to CPB, their body is cooled below the normal body temperature. This is known as hypothermia. This is because scientific studies have previously shown that reduced body temperature lowers metabolism and therefore offers more protection to the brain and other organs due to the reduced oxygen requirement. The evidence supporting this practice, however, has been challenged throughout the history of cardiac surgery, with studies supporting that normothermia, or normal body temperature, is a safe alternative. Despite this, the practice of hypothermia has persisted. Published data from a survey of 139 cardiac surgeons in the United Kingdom showed that 84% still routinely employ hypothermic CPB during surgery.\n\nTo assess whether normothermic or hypothermic CPB is safer, a clinical trial requiring a large sample size and high recruitment rates will be required. Therefore, the investigators aim to assess firstly the feasibility of trial recruitment and allocation adherence in this study. 100 adults across 10 different cardiac surgery centres in the United Kingdom will be recruited to a multicentre feasibility randomised controlled trial comparing normothermia (active comparator) against hypothermia (control comparator) during cardiopulmonary bypass in cardiac surgery. This study will also test the ability of the Cardiothoracic Interdisciplinary Research Network (CIRN), a trainee-led research collaborative, to collect pilot data on Major Adverse Cardiac and Cerebrovascular Events (MACCE) using a regulation-approved electronic application HealthBitⓇ. Participants will also be asked to complete quality of life surveys. The results of this study will subsequently inform a large, adequately powered randomised controlled trial for optimal temperature management during CPB.",[533,534,535,536],"Ischemic Heart Disease","Valvular Heart Disease","Cardiovascular Diseases","Surgery-Complications",[538,539,540,541],"cardiopulmonary bypass","hypothermia","myocardial protection","neurologic protection",{"date":515,"type":47},{"date":544,"type":47},"2024-05-20",{"date":546,"type":22},"2026-02",{"name":53,"class":54},11,{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":4,"eligibilityCriteria":555,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":556,"enrollmentInfo":557,"targetDuration":4,"studyType":23,"phases":559,"briefSummary":560,"conditions":561,"keywords":564,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":569,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":574,"locationsCount":88},"100552326","a-study-looking-to-improve-sleep-and-reduce-sedentary-behaviour-in-those-living-with-type-2-diabetes-mellitus-100552326","NCT06471634","A Study Looking to Improve Sleep and Reduce Sedentary Behaviour in Those Living With Type 2 Diabetes Mellitus","An Efficacy Study Exploring the Optimisation of Sleep and the Reduction of Sedentary Behaviour in Those Living With Type 2 Diabetes Mellitus","Inclusion Criteria:\n\n* Diagnosed with Diabetes Mellitus type 2 for longer than 3 months\n* Participant is willing and able to give informed consent to take part in the study.\n* Sleep disorder symptom checklist 25 (SDS-CL-25) of ≥5 on insomnia criteria.\n* Not at high risk of undiagnosed Obstructive Sleep Apnoea (OSA), scoring ≥5 on STOP BANG scale (snoring, tired, observed, pressure, body mass index, age, neck size, gender) diagnosed treated OSA is acceptable.\n* Glycated haemoglobin (HbA1c) of 10% or less (86 mmol\u002Fmol) or less\n* Male or Females.\n* ≥ 18 ≤ 75 years of age.\n* Able to walk without the use of an assistive device or requiring assistance from another person.\n* Not undertaking more than 75 minutes a week of strenuous exercise or sport.\n* Not taking opioids\n* Be treatment stable for at least 3 months\n* Accelerometer measurement of SE ≤ 85%\n* An understanding that CBTi may exacerbate sleep deprivation in the short term which may impact on certain aspects of daily life.\n\nExclusion Criteria:\n\n* Individuals living with narcolepsy or diagnosed parasomnia\n* Individuals with type 1 diabetes or gestational diabetes\n* Recent cardiovascular event (within the last 6 months).\n* Currently on opioids\n* Diagnosed with borderline personality disorder, psychosis, adult attention deficit hyperactivity disorder (ADHD) or schizophrenia (self-reported).\n* Individuals living with epilepsy or seizures.\n* Shift workers\n* Female participant planning to become pregnant with the timeframe of the study or is currently pregnant.\n* Terminal illness.","75 Years",{"count":558,"type":22},44,[68],"The goal of this clinical feasibility trial is to learn whether the investigators can improve sleep and reduce sedentary behaviour in people living with Type 2 diabetes mellitus with sleep problems. The main questions it aims to answer are: • question 1, can objectively measured sleep and sedentary behaviour be improved in the participants and • question 2, what effect will this have on a number of physical and physiological markers. Participants in the intervention group will be asked to keep sleep diaries and attend regular meetings with a qualified coach who will use a specific talking therapy to try to improve sleep and with use behaviour change techniques to help them be less sedentary. Researchers will compare the control group to the intervention group to see if effects differ between groups.",[31,562,563],"Insomnia","Sedentary Behavior",[129,562,565,31,566,567],"Sedentary behaviour","Cognitive Behaviour Therapy insomnia (CBTi)","Behaviour change","2025-03-24",{"date":570,"type":47},"2025-03-27",{"date":572,"type":47},"2024-09-02",{"date":84,"type":22},{"name":53,"class":54},{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":581,"eligibilityCriteria":582,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":583,"targetDuration":4,"studyType":99,"phases":4,"briefSummary":585,"conditions":586,"keywords":588,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":592,"lastUpdatePostDateStruct":593,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":598,"locationsCount":88},"100543362","the-relationship-between-controlling-risk-factors-and-cerebral-haemodynamics-in-lacunar-stroke-100543362","NCT06354881","The Relationship Between Controlling Risk Factors and Cerebral Haemodynamics in Lacunar Stroke","Understanding the Relationship Between Controlling Risk Factors and Cerebral Haemodynamic Changes in Lacunar Stroke, and Its Interaction With Ageing","LACUNAR_CA","Inclusion Criteria:\n\n* Adults aged between 18-120 years.\n* Diagnosis of lacunar stroke syndrome.\n* New diagnosis or known diagnosis of hypertension and\u002For diabetes.\n\nExclusion Criteria:\n\n* Those who lack capacity can have a personal consultee consent to the study if they can still perform study requirements such as the sit-stand manoeuvre. Those who either cannot perform the manoeuvre or do not have a personal consultee to allow them to consent, are not able to take part.\n* Those with poorly controlled medical comorbidities affecting cerebral haemodynamics. (eg., heart failure).",{"count":584,"type":22},75,"The goal of this observational study is to look at differences in brain blood flow before and after management of risk factors such as high blood pressure and diabetes in patients with lacunar stroke. Participants will be asked to undergo a simple brain blood flow assessment at their initial appointment, whereby they will be asked to sit and stand twice. The patients will then be asked for a follow-up assessment 4 weeks after, identical to the first. This will allow us to look at any changes in brain blood flow from before management of risk factors and 4 weeks after management of risk factors.",[587],"Lacunar Stroke",[589,326,590,591],"Lacunar","Cerebral Autoregulation","Cerebral Blood Flow","2025-03-21",{"date":568,"type":47},{"date":595,"type":47},"2024-05-02",{"date":597,"type":22},"2026-03",{"name":53,"class":54},{"id":600,"slug":601,"hasResults":12,"nctId":602,"briefTitle":603,"officialTitle":603,"acronym":604,"eligibilityCriteria":605,"healthyVolunteers":229,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":606,"targetDuration":4,"studyType":99,"phases":4,"briefSummary":608,"conditions":609,"keywords":611,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":617,"lastUpdatePostDateStruct":618,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":624,"locationsCount":88},"100581003","understanding-the-increased-risk-of-atrial-fibrillation-in-athletes-a-case-control-study-100581003","NCT06844656","Understanding the Increased Risk of Atrial Fibrillation in Athletes: a Case-control Study","AFLETES-ECG","Inclusion Criteria:\n\n* ≥18 years of age at the time of enrolment, male and female.\n* History of atrial fibrillation confirmed on ECG - either paroxysmal or persistent.\n* Competitive athlete. Defined as:\n\n  1. Competed in endurance sports with a total cumulative moderate to high intensity of \\> 1500 hours.\n  2. Have participated in at least one competitive event in the last 10 years.\n\nExclusion Criteria:\n\n* Permanent atrial fibrillation.\n* History of pre-existing cardiovascular disease :\n\n  1. Atherosclerotic disease: previous myocardial infarction, symptomatic coronary artery disease or Peripheral peripheral arterial disease\n  2. Left ventricular systolic dysfunction (EF \\\u003C 45%)\n  3. Heart muscle disease: cardiomyopathies, Infiltrative diseases of the heart\n  4. Complex Congenital heart disease\n  5. Moderate or severe valvular disease\n  6. Uncontrolled hypertension (\\>180\u002F100mmHg)",{"count":607,"type":22},200,"Exercise is beneficial to heart health, however, there appears to be a 'U' shaped relationship where too much exercise may increase the risk of an irregular heart rhythm, called atrial fibrillation. Endurance athletes may have up to a 2.5-fold higher risk of developing atrial fibrillation than non-athletic controls.\n\nThe mechanisms behind this increased risk of atrial fibrillation are not the well understood. It is thought to be a mixture of enlarged heart chambers, low resting heart rate, genetic predisposition and possibly scarring in the heart. In this study, the investigators will investigate the electrical activity changes in the heart, using a high-quality electrocardiogram (ECG) and relate this to changes in the heart size measured by ultrasound and MRI. Cardiopulmonary exercise testing will determine fitness (V̇O2 max) and assess the heart's electrical activity during exercise.\n\nThis will be a case-control study where athletes with and without atrial fibrillation will be recruited. The investigators hope the results of this study can improve our understanding of atrial fibrillation in athletes by associating atrial fibrillation with structural and electrical differences which may aid the prediction of future atrial fibrillation development and help guide more athlete-specific treatment pathways.",[610],"Atrial Fibrillation (AF)",[612,613,614,615,72,616],"Atrial Fibrillation","Athletes","Sport","Physical Activity","Arrhythmias","2025-02-21",{"date":619,"type":47},"2025-02-25",{"date":621,"type":22},"2025-02-28",{"date":623,"type":22},"2026-10-10",{"name":53,"class":54},{"id":626,"slug":627,"hasResults":12,"nctId":628,"briefTitle":629,"officialTitle":630,"acronym":631,"eligibilityCriteria":632,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":633,"enrollmentInfo":634,"targetDuration":4,"studyType":99,"phases":4,"briefSummary":635,"conditions":636,"keywords":638,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":641,"lastUpdatePostDateStruct":642,"startDateStruct":644,"completionDateStruct":646,"leadSponsor":648,"locationsCount":88},"100547615","ischaemic-lesions-in-acute-intracerebral-haemorrhage-100547615","NCT06410274","Ischaemic Lesions in Acute Intracerebral Haemorrhage","Ischaemic Lesions in Acute Intracerebral Haemorrhage: Pathophysiological Investigation Using Novel Multimodal Cerebral and Systemic Haemodynamic Assessments","CHALLENGE-ICH","Inclusion Criteria:\n\n* Clinical diagnosis of a haemorrhagic stroke on CT imaging within 48 hours of onset (for patients waking with a stroke, time of onset will be taken to be the time when the patient was last asymptomatic).\n* Male or female, aged 18 years or above.\n\nExclusion Criteria:\n\n* MRI imaging is contraindicated or unlikely to tolerate scanning process due to clinical instability (GCS \\\u003C8, unable to lie supine).\n* Patients requiring anaesthesia.\n* Male or Female, aged under 18 years.\n* Clinical diagnosis of stroke greater than 48 hours from onset","120 Years",{"count":125,"type":22},"The aim of this observational study is to determine how and why inadequate brain blood flow occurs after bleeding in patients with intracerebral haemorrhage (ICH). Treatment for strokes caused by burst blood vessels involves reducing blood pressure (BP) to stop the bleeding. However, this reduction in BP may affect blood flow, causing blockages in blood vessels within the brain. Fast breathing also affects brain blood flow. Therefore, participants will be asked to undergo a simple brain blood flow assessment using transcranial Doppler (TCD) within 48 hours upon admission to hospital. Patients will then have a follow-up TCD assessment at 4-7 days post-ICH onset, in addition to an MRI scan at \\>7 days. This research will help to confirm if blockages after bleeding are caused by reduced blood flow within the brain.",[637],"Intracerebral Haemorrhage",[326,590,591,639,640],"Transcranial Doppler","Magnetic Resonance Imaging","2024-09-17",{"date":643,"type":47},"2024-09-19",{"date":645,"type":47},"2024-06-01",{"date":647,"type":22},"2029-01-31",{"name":53,"class":54},{"id":650,"slug":651,"hasResults":12,"nctId":652,"briefTitle":653,"officialTitle":654,"acronym":655,"eligibilityCriteria":656,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":556,"enrollmentInfo":657,"targetDuration":4,"studyType":99,"phases":4,"briefSummary":659,"conditions":660,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":662,"lastUpdatePostDateStruct":663,"startDateStruct":665,"completionDateStruct":667,"leadSponsor":668,"locationsCount":88},"100283732","chronotype-of-patients-with-diabetes-and-effect-on-glycaemic-control-100283732","NCT02973412","Chronotype of Patients With Diabetes and Effect on Glycaemic Control","Chronotype of Patients With Diabetes and Effect on Glycaemic Control: The CODEC Study","CODEC","Inclusion Criteria:\n\n1. Participant is willing and able to give informed consent for participation in the study\n2. T1DM or established T2DM (\\>6months since diagnosis)\n3. Male or Female\n4. Aged 18-75 years inclusive\n5. BMI less than or equal to 45kg\u002Fm² inclusive\n6. No known sleep disorders except Obstructive Sleep Apnoea (OSA)\n7. On any glucose-lowering therapy (T1DM or T2DM) or lifestyle modification for management of T2DM\n8. Good command of the English language\n\nExclusion Criteria:\n\n1. Participant is unwilling or unable to give informed consent\n2. Anyone without a good command of the English language\n3. Anyone \\\u003C18 years of age and \\>75 years of age\n4. BMI greater than 45 kg\u002Fm²\n5. A regular cannabis user i.e. weekly use\n6. Have a terminal illness\n7. A known sleep disorder that is not OSA\n8. Regular use of the following medicines i.e. Weekly use: (Wakefulness promoting agents Modafinil, Amphetamine derivatives, Methylphenidate; Sedatives including benzodiazepines, Z-drugs (zopiclone, zolpidem \\& zaleplon); Melatonin, including Circadin and melatonin analogues; Clonazepam and other drugs for nocturnal movement disorders).",{"count":658,"type":22},3447,"The aim of this study is to explore the associations between chronotype and glycaemic control, cardiometabolic health and other lifestyle factors.",[661,31],"Diabetes Mellitus, Type 1","2024-02-14",{"date":664,"type":47},"2024-02-15",{"date":666,"type":47},"2016-12-07",{"date":169,"type":22},{"name":53,"class":54},""]