[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558794":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":74,"centralContacts":78,"locations":88,"responsibleParty":107,"collaborators":110,"id":113,"slug":114,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":115,"sex":120,"minAge":121,"maxAge":10,"enrollmentInfo":122,"targetDuration":10,"studyType":125,"phases":10,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":90,"whyStopped":10,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Cambridge University Hospitals NHS Foundation Trust","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with heart failure",null,"Diagnosed with chronic stable heart failure NYHA Class 3 or 4 (either during most recent cardiology\u002Fheart failure clinic visit, or ADHF during recent\u002Fcurrent hospitalization).",[13,14,15,16,17,18,19,20,21,22,23,24],"Other: Height, weight, and BMI","Other: Medical history","Other: Physical examination","Diagnostic Test: Venous blood samples","Other: Resting vital signs","Diagnostic Test: Transthoracic echocardiogram","Other: Sound recordings","Diagnostic Test: Lung ultrasound","Other: KCCQ questionnaire","Other: ASCEND-HF score","Other: Composite Everest congestion score","Diagnostic Test: Bio impedance and total body water measurement",[26,30,34,38,43,47,51,55,58,62,66,70],{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"Height, weight, and BMI","Height, weight measurement and BMI calculation",[9],{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":10},"Medical history","Brief medical history including medications\u002Fallergies and heart failure related healthcare utilisation over previous 12 months",[9],{"type":6,"name":35,"description":36,"armGroupLabels":37,"otherNames":10},"Physical examination","Brief physical examination",[9],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":10},"DIAGNOSTIC_TEST","Venous blood samples","Venous blood samples, to include WCC, HB, CRP and NTproBNP",[9],{"type":6,"name":44,"description":45,"armGroupLabels":46,"otherNames":10},"Resting vital signs","HR, BP, RR, oxygen saturations on air)",[9],{"type":39,"name":48,"description":49,"armGroupLabels":50,"otherNames":10},"Transthoracic echocardiogram","LVEF, IVC collapsibility, LV filling pressure, PA pressure",[9],{"type":6,"name":52,"description":53,"armGroupLabels":54,"otherNames":10},"Sound recordings","Sound recordings (voice\u002Fcough\u002Fchest) recorded with the in-built microphone in a smartphone",[9],{"type":39,"name":56,"description":56,"armGroupLabels":57,"otherNames":10},"Lung ultrasound",[9],{"type":6,"name":59,"description":60,"armGroupLabels":61,"otherNames":10},"KCCQ questionnaire","Kansas City Cardiomyopathy Questionnaire",[9],{"type":6,"name":63,"description":64,"armGroupLabels":65,"otherNames":10},"ASCEND-HF score","An in-hospital congestion score which risk stratifies patients admitted with worsening heart failure, developed for the Acute study of clinical effectiveness of Nesiritide in decompensated heart failure trial",[9],{"type":6,"name":67,"description":68,"armGroupLabels":69,"otherNames":10},"Composite Everest congestion score","A shortened version of the original 18-point score from the EVEREST trial",[9],{"type":39,"name":71,"description":72,"armGroupLabels":73,"otherNames":10},"Bio impedance and total body water measurement","Bio impedance and total body water measurement using TANITA device",[9],[75],{"name":76,"affiliation":5,"role":77},"Joseph Cheriyan","PRINCIPAL_INVESTIGATOR",[79,84],{"name":80,"role":81,"phone":82,"phoneExt":10,"email":83},"Erdem Demir","CONTACT","+44 1223 256621","erdem.demir1@nhs.net",{"name":85,"role":81,"phone":86,"phoneExt":10,"email":87},"Heike Templin","+44 1223 250874","heike.templin@nhs.net",[89],{"facility":5,"status":90,"city":91,"state":92,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":102},"RECRUITING","Cambridge","Cambridgeshire","CB2 0QQ","United Kingdom","UK",{"type":97,"coordinates":98},"Point",[99,100],0.11667,52.2,{"lat":100,"lon":99},[103,106],{"name":104,"role":81,"phone":10,"phoneExt":10,"email":105},"Joseph Cheriyan, MBChB MA FRCP FESC FACC","j.cheriyan@nhs.net",{"name":104,"role":77,"phone":10,"phoneExt":10,"email":10},{"type":77,"investigatorFullName":108,"investigatorTitle":109,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Joseph Cheriyan, MBChB, MA, FRCP, FESC, FACC","Consultant Clinical Pharmacologist\u002FAffiliated Associate Professor",[111],{"name":112,"class":6},"University of Cambridge","100558794","utilising-ai-analysis-of-sounds-to-predict-heart-failure-decompensation-100558794",false,"NCT06555757","Utilising AI Analysis of Sounds To prEdict heaRt failurE decOmpensation","STEREO","Inclusion Criteria:\n\n* Male or Female, aged 18 years or above.\n* Diagnosed with chronic stable heart failure NYHA Class 3 or 4 (either during most recent cardiology\u002Fheart failure clinic visit, or ADHF during recent\u002Fcurrent hospitalization).\n* Participant is willing and able to give informed consent for participation in the study.\n* Participant has a smartphone device and can download a purposely designed mobile application on their phone (with guidance from the study investigators) or is willing to have sound recordings via a smartphone device loaned for the purpose of the study.\n\nExclusion Criteria:\n\n* Unable to provide consent\n* Patients requiring continuous oxygen therapy at flow rates that cannot be provided through nasal cannula\n* Patients with currently known pneumonia\n* Patients with known significant pulmonary disease including asthma, COPD, pulmonary fibrosis\u002Finterstitial lung disease, pulmonary hemorrhage.\n* Patients with current Pulmonary embolus\n* Patients with other intercurrent acute symptomatic illness (e.g., viral\u002Fbacterial infection) at time of recording\n* Patients requiring continuous oxygen therapy at flow rates that cannot be provided through nasal cannula\n* Patients with tracheostomy or who have undergone a surgical procedure to the head\u002Fneck\u002Flarynx which would affect the normal functioning of the vocal cords.\n* Aphasic\n* Patients excluded at PI discretion","ALL","18 Years",{"count":123,"type":124},250,"ESTIMATED","OBSERVATIONAL","Heart failure impacts more than 2% of people in the UK (United Kingdom) and leads to about 5% of emergency hospital visits. Patients might have slowly worsening symptoms or suddenly face acute decompensated heart failure (ADHF), marked by intense difficulty in breathing due to fast-developing lung congestion. This is a serious emergency requiring in-hospital treatment and monitoring. Once stable, patients usually have a phase where symptoms remain constant. But as time goes on, those with heart failure often face more frequent and prolonged episodes of ADHF.\n\nFluid build-up (pulmonary congestion) in the lungs is a key issue in heart failure, and catching it early helps avoid unexpected hospital stays. Spotting these early signs outside the hospital can be tough, as symptoms aren't always clear. Study investigators are working on a new, non-invasive way to identify these early signs using AI (artificial intelligence) to analyse subtle changes in a patient's voice, cough, and breathing sounds. This tool will act as an early warning for patients and their heart care teams, allowing quicker treatment. This could make heart failure episodes less severe and reduce the need for hospital visits.\n\nThis research has two parts. First, a small pilot trial with up to 50 patients. The findings will guide and inform a larger study involving up to 200 patients. From this larger study, investigators will develop the final version of the AI algorithm. The results from the Part A and Part B of this research will guide the investigators in planning a future clinical trial. This trial will confirm if the AI algorithm can be effectively used as a medical tool for heart failure care within the NHS (National Health Service). Study investigators will seek the necessary ethical approval before starting this trial.",[128],"Heart Failure",[130,131,132],"heart failure","cardiovascular","artificial intelligence","2026-05-07",{"date":135,"type":136},"2026-05-12","ACTUAL",{"date":138,"type":136},"2024-09-18",{"date":140,"type":124},"2027-08-15",{"name":5,"class":6},1]