[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523119":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":38,"responsibleParty":54,"collaborators":56,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":18,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":82,"overallStatus":41,"whyStopped":18,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Imperial College London","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Withdrawal of treatment with eplerenone or spironolactone, and empagliflozin and dapalgiflozin","EXPERIMENTAL","Gradual, supervised withdrawal of ineralocorticoid receptor antagonists (spironolactone or eplerenone) and sodium glucose cotransporter 2 inhibitor (dapagliflozin or empagliflozin) over 4-16 weeks. Continued monitoring off study therapies during the cross-over phase.",[13],"Drug: Other",{"label":15,"type":16,"description":17,"interventionNames":18},"Continued treatment with eplerenone or spironolactone, and empagliflozin and dapagliflozin","NO_INTERVENTION","Continuation of usually prescribed pharmacological therapy over 16 weeks followed by cross-over to withdrawal of SGLT2i and MRA over the subsequent 4-16 weeks.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Other","Withdrawal of mineralocorticoid receptor antagonists and\u002For sodium glucose cotransporter 2 inhibitors",[9],[26],"Withdrawal of spironolactone or eplerenone and dapagliflozin or empagliflozin",[28],{"name":29,"affiliation":30,"role":31},"Brian P Halliday, MBChB","Imperial College London, Royal Brompton Hospital","PRINCIPAL_INVESTIGATOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":18,"email":37},"Saad Javed, MBChB","CONTACT","02073528121","tred2trial@imperial.ac.uk",[39],{"facility":40,"status":41,"city":42,"state":18,"zip":18,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Royal Brompton Hospital","RECRUITING","London","United Kingdom","UK",{"type":46,"coordinates":47},"Point",[48,49],-0.12574,51.50853,{"lat":49,"lon":48},[52],{"name":53,"role":35,"phone":18,"phoneExt":18,"email":37},"Saad Javed",{"type":55,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[57],{"name":58,"class":6},"Royal Brompton & Harefield NHS Foundation Trust","100523119","therapy-to-maintain-remission-in-dilated-cardiomyopathy-100523119",false,"NCT06091475","Therapy to Maintain Remission in Dilated Cardiomyopathy","A Randomised Trial Examining Therapy to Maintain Remission in Dilated Cardiomyopathy","TRED-HF2","Inclusion Criteria:\n\n1. a diagnosis of dilated cardiomyopathy,\n2. previous left ventricular ejection fraction (LVEF) \\\u003C40% (on echocardiography or cardiovascular magnetic resonance \\[CMR\\]),\n3. current LVEF \\>50% with normal left ventricular end-diastolic volume (LVEDV),\n4. plasma NT-pro-BNP\\\u003C250ng\u002FL,\n5. New York Heart Association (NYHA) class I,\n6. sinus rhythm,\n7. taking a beta-blocker and an angiotensin converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB) or sacubitril-valsartan, along with either a mineralocorticoid receptor antagonist (MRA) and\u002For sodium glucose co-transporter 2 inhibitor (SGLT2i).\n\nExclusion Criteria:\n\n1. Atrial fibrillation,\n2. prior sustained ventricular tachycardia or fibrillation,\n3. a known likely pathogenic or pathogenic variant in LMNA\u002FDSP\u002FFLNC\u002FRBM20,\n4. sudden cardiac or heart failure death in a first degree relative \\\u003C50 years,\n5. contraindication to CMR,\n6. estimated glomerular filtration rate (eGFR) \\\u003C60mls\u002Fmin,\n7. planned pregnancy,8) active myocardial inflammation,\n\n9\\) diabetes mellitus managed with an SGLT2i, 10) urinary albumin-to-creatine ratio of 200-5000 (mg:g) and eGFR\\\u003C 75mls\u002Fmin.","ALL","18 Years","85 Years",{"count":71,"type":72},50,"ESTIMATED","INTERVENTIONAL",[75],"NA","One third of patients diagnosed with heart failure demonstrate left ventricular reverse remodelling and recovery of cardiac function following a period of medical therapy. The TRED-HF trial investigated the impact of therapy withdrawal in this cohort and found that 40% of patients relapsed within 6 months of stopping treatment. In this follow-on study, the investigators will investigate the safety of therapy withdrawal of sodium cotransporter 2 inhibitors (SGLT2i) and mineralocorticord receptor anatagonists (MRAs) in patients with a previous diagnosis of heart failure and recovered cardiac function, in a randomised controlled trial to assess whether this maintains remission in this population.",[78,79,80,81],"Heart Failure","Cardiomyopathy, Dilated","Cardiomyopathies","Heart Diseases",[83,84],"Cardiomyopathy","heart failure","2024-09-03",{"date":87,"type":88},"2024-09-19","ACTUAL",{"date":90,"type":88},"2023-12-02",{"date":92,"type":72},"2026-09-15",{"name":5,"class":6},1]