[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100407915":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":37,"responsibleParty":52,"collaborators":54,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":24,"enrollmentInfo":72,"targetDuration":24,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":39,"whyStopped":24,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"University of Edinburgh","OTHER",[8,14],{"label":9,"type":6,"description":10,"interventionNames":11},"Patients with heart failure without type 2 diabetes","60 patients with heart failure without type 2 diabetes will be recruited and will either be randomised to placebo or Dapagliflozin after their baseline cardiac MRIs. They will have 2 cardiac MRIs (gadolinium and manganese enhanced) at baseline and further manganese enhanced cardiac MRI at 1 month post randomisation + gadolinium and manganese enhanced cardiac MRI at 6 months post randomisation.",[12,13],"Drug: Dapagliflozin 10 milligrams [Farxiga]","Drug: Placebo",{"label":15,"type":6,"description":16,"interventionNames":17},"Patients with heart failure with type 2 diabetes","60 patients with heart failure with type 2 diabetes will be recruited and will either be randomised to placebo or Dapagliflozin after their baseline cardiac MRIs. They will have 2 cardiac MRIs (gadolinium and manganese enhanced) at baseline and further manganese enhanced cardiac MRI at 1 month post randomisation + gadolinium and manganese enhanced cardiac MRI at 6 months post randomisation.",[12,13],[19,25],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Dapagliflozin 10 milligrams [Farxiga]","Patients with heart failure with or without type 2 diabetes will be either randomised to 10mg Dapagliflozin once daily or matched placebo.",[15,9],null,{"type":20,"name":26,"description":22,"armGroupLabels":27,"otherNames":24},"Placebo",[15,9],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Shruti Joshi, MBBS, MRCP","CONTACT","0131 650 1000","sjoshi@ed.ac.uk",{"name":35,"role":31,"phone":32,"phoneExt":24,"email":36},"David Newby, PhD, BM, DM, MRCP, DSc, FRSE","d.e.newby@ed.ac.uk",[38],{"facility":5,"status":39,"city":40,"state":41,"zip":24,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Edinburgh","Scotland","United Kingdom","UK",{"type":45,"coordinates":46},"Point",[47,48],-3.19648,55.95206,{"lat":48,"lon":47},[51],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},{"type":53,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[55,58],{"name":56,"class":57},"AstraZeneca","INDUSTRY",{"name":59,"class":60},"NHS Lothian","OTHER_GOV","100407915","the-dapa-memri-trial-100407915",false,"NCT04591639","The DAPA-MEMRI Trial","An Observational Cross-sectional Study and a Double-blind Placebo Controlled Randomised Controlled Trial to Assess the Effect of Dapagliflozin on Myocardial Calcium-handling in Patients With Heart Failure- The DAPA-MEMRI Trial.","DAPA-MEMRI","Inclusion Criteria:\n\nPatients with heart failure (with or without type 2 diabetes mellitus)\n\n* Aged over 18 years\n* Diagnosis of symptomatic reduced ejection fraction heart failure for at least 2 months\n* Left ventricular ejection fraction ≤40%\n* Elevated N-terminal pro B-type natriuretic peptide (\\>125 pg\u002FmL)\n* Clinical diagnosis of type 2 diabetes mellitus for 50% of patient population - on stable therapy for at least 12 months or more.\n\nPatients with Type 2 Diabetes Mellitus and no heart failure\n\n* Aged over 18 years\n* Clinical diagnosis of type 2 diabetes mellitus (diagnosed by either HbA1c of 48mmol\u002Fmol (6.5%) or greater or fasting plasma glucose level of 7mmol\u002FL or greater at the time of diagnosis)\n\n  \\- on stable therapy for at least 12 months or more.\n* Normal left ventricular systolic ejection fraction\n\nHealthy Volunteers\n\n* Aged over 18 years\n* Normal left ventricular ejection fraction and glycaemia\n* No clinically significant co-morbid conditions\n\nExclusion Criteria:\n\nPatients with heart failure (with or without type 2 diabetes mellitus)\n\n* Receiving an SGLT2 inhibitor within 8 weeks of enrolment\n* Previous intolerance of, or contraindication to, an SGLT2 inhibitor\n* Standard magnetic resonance imaging safety exclusions\n* Severe renal impairment (eGFR \\\u003C30millilitre\u002Fmin. 1.73m2)\n* Type 1 diabetes mellitus\n* Symptomatic hypotension or systolic blood pressure \\\u003C95 mmHg\n* Recent (within 12 weeks) hospitalisation for heart failure, acute cardiovascular event (such as myocardial infarction or stroke) or coronary re-vascularisation.\n* 2nd or 3rd degree atrioventricular block Atrial fibrillation or flutter with poor ventricular rate control (\\>100 \u002Fmin)\n* Heart failure due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease\n* New York Heart Association grade IV heart failure\n* Obstructive liver function testing abnormalities\n* Concomitant digoxin, diltiazem or verapamil therapy.\n\nPatients with type 2 diabetes mellitus and no heart failure\n\n* Other major clinically significant co-morbid conditions\n* History of ischaemic heart disease or present history suggestive of probable clinically significant underlying ischaemic heart disease\n* Standard magnetic resonance imaging safety exclusions\n* Moderate or severe renal impairment (eGFR \\\u003C45 mL\u002Fmin. 1.73m2)\n* Receiving a SGLT2 inhibitor at any time\n* Symptomatic hypotension or systolic blood pressure \\\u003C95 mmHg\n* Abnormal electrocardiogram\n* Clinically significant abnormalities of clinical haematology or biochemistry measurements.\n\nHealthy Volunteers\n\n* Major or clinically significant cardiovascular disease\n* Diabetes mellitus\n* Receiving an SGLT2 inhibitor at any time\n* Standard magnetic resonance imaging safety exclusions\n* Moderate or severe renal impairment (eGFR \\\u003C45 mL\u002Fmin. 1.73m2)\n* Symptomatic hypotension or systolic blood pressure \\\u003C95 mmHg\n* Abnormal electrocardiogram\n* Clinically significant abnormalities of clinical haematology or biochemistry measurements.",true,"ALL","18 Years",{"count":73,"type":74},160,"ESTIMATED","INTERVENTIONAL",[77],"NA","Diabetes mellitus is among the top 10 causes of death worldwide with an increasing incidence. Patients with diabetes are at risk of developing heart failure which is characterised by significant changes in the heart muscle including scarring and thickening. Contraction of the heart involves movement of calcium across the heart muscle and disruption of this process is an early change seen in heart failure. Recently, a drug therapy (SGLT2 inhibitor therapy) in patients with diabetes was shown to benefit patients with heart failure but the mechanisms of benefit are unknown.\n\nOur hypothesis is that calcium handling is altered in patients with either type 2 diabetes mellitus (T2DM) or heart failure and that SGLT2 inhibitors can improve this in heart failure irrespective of the presence of T2DM.\n\nScanning the heart using magnetic resonance imaging (MRI) enables detailed assessment of its structure and function by using a new contrast 'dye' containing manganese that has shown advantages over traditional contrast. We plan to further test this new dye as it has the potential to track and quantify improvements in heart function over time and detect changes in calcium handling in the heart muscle, making it an ideal measure to identify the mechanisms of benefit from SGLT2 inhibitor therapy.\n\nThe study population will comprise patients with heart failure with and without type 2 diabetes, patients with type 2 diabetes without heart failure and healthy volunteers. Baseline comparisons will be made between the four groups before progressing to the randomised controlled trial with heart failure patients only. Patients will have a clinical assessment and blood tests, electrocardiogram, echocardiogram and MRI of the heart at each visit.\n\nIf successful, this study will give us significant insights into mechanisms of action of SGLT2 inhibitors in heart failure and will enable us to tailor specific treatments in heart failure patients.",[80,81],"Heart Failure","Diabetic Cardiomyopathies",[83,84,85],"Heart failure","Sodium glucose Co-transporter 2 inhibitor therapy","Manganese enhanced cardiac magnetic resonance imaging","2025-06-23",{"date":88,"type":89},"2025-06-24","ACTUAL",{"date":91,"type":89},"2020-08-19",{"date":93,"type":74},"2028-07-28",{"name":5,"class":6},1]