[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539516":3},{"organization":4,"outcomesModule":7,"designInfo":65,"detailedDescription":76,"studyPopulation":64,"armGroups":77,"interventions":90,"overallOfficials":101,"centralContacts":106,"locations":112,"responsibleParty":150,"collaborators":64,"id":152,"slug":64,"hasResults":153,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":153,"sex":159,"minAge":160,"maxAge":161,"enrollmentInfo":162,"targetDuration":64,"studyType":165,"phases":166,"briefSummary":168,"conditions":169,"keywords":172,"overallStatus":114,"whyStopped":64,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":186},{"fullName":5,"class":6},"4th Military Clinical Hospital with Polyclinic, Poland","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":64},[9],{"measure":10,"description":11,"timeFrame":12},"Primary efficacy composite endpoint (cancer therapeutics related cardiac dysfunction) at 12 months.","Incidence of cancer therapeutics related cardiac dysfunction defined as:\n\n1. the appearance of heart failure symptoms (NYHA class I-IV) due to an impairment of heart function or structure within 12 months; or\n2. asymptomatic decrease in left ventricular ejection fraction \\> 10% after 12 months; or\n3. asymptomatic decrease in left ventricular ejection fraction \\\u003C 10% but up to 40-49% after 12 months; or\n4. asymptomatic decrease in global left ventricular longitudinal strain \\>15% after 12 months; or\n5. asymptomatic increase in biomarkers (troponin I \\> upper reference limit (99th centile) and increase of at least 30% from pre-treatment concentration or NTproBNP \\> 125 pg\u002Fml and increase of at least 30% from baseline) after 12 months.","12 months",[14,18,22,25,28,30,33,37,40,42,44,46,49,52,55,58,61],{"measure":15,"description":16,"timeFrame":17},"Secondary efficacy composite endpoint (cancer therapeutics related cardiac dysfunction) at 6 months.","Incidence of cancer therapeutics related cardiac dysfunction defined as:\n\n1. emergence of heart failure symptoms (NYHA class I-IV) due to impaired cardiac function or structure at 6 months; or\n2. decrease LVEF \\> 10% after 6 months; or\n3. decrease LVEF \\\u003C 10% but to a value of 40-49% after 6 months; or\n4. a decrease in global longitudinal strain of \\> 15% after 6 months; or\n5. asymptomatic increase in biomarkers (troponin I \\> upper reference limit (99th centile) and an increase of at least 30% from pre-treatment concentration or NTproBNP \\>125pg\u002Fml and an increase of at least 30% from baseline) after 6 months.","6 months",{"measure":19,"description":20,"timeFrame":21},"Change in left ventricular ejection fraction at 6 and 12 months.","Assessed by transthoracic echocardiography.","6 and 12 months",{"measure":23,"description":24,"timeFrame":21},"Change in left ventricular diastolic function at 6 and 12 months.","Assessed as the ratio of E\u002FE', i.e. maximum mitral annular inflow velocity during the rapid ventricular filling phase, to maximum mitral annular motion velocity by tissue Doppler during the rapid ventricular filling phase.",{"measure":26,"description":27,"timeFrame":21},"Change in Troponin I after 6 and 12 months.","Secondary.",{"measure":29,"description":27,"timeFrame":21},"Change in NTproBNP levels at 6 and 12 months.",{"measure":31,"description":32,"timeFrame":21},"Quality of life at 6 and 12 months assessed using the five-dimensional EQ-5D questionnaire.","The EQ-5D questionnaire consists of two parts: descriptive one, which measures five dimensions of health (mobility, self care, usual activities, pain \\& discomfort, anxiety \\& depression) and EQ Visual Analogue Scale numbered from 0 to 100, where higher value indicate better self-reported health.",{"measure":34,"description":35,"timeFrame":36},"Occurrence of death from any cause.","Secondary safety endpoint.","13 months (additional 1 month of safety follow-up after end of treatment).",{"measure":38,"description":39,"timeFrame":36},"Composite endpoint of cardiovascular events.","Secondary safety endpoint. Occurrence of death from cardiovascular causes, nonfatal myocardial infarction, non-fatal stroke.",{"measure":41,"description":35,"timeFrame":36},"Occurrence of death from any cardiovascular reasons.",{"measure":43,"description":35,"timeFrame":36},"Occurrence of non-fatal myocardial infarction.",{"measure":45,"description":35,"timeFrame":36},"Occurrence of non-fatal stroke.",{"measure":47,"description":48,"timeFrame":36},"Occurrence of hypoglycaemia.","Secondary safety endpoint. Hypoglycaemia is defined as serum glucose level 3 mmol\u002Fl (\\\u003C54 mg\u002Fdl) with coexisting related clinical symptoms.",{"measure":50,"description":51,"timeFrame":36},"Occurrence of ionic disorders.","Secondary safety endpoint, defined as occurrence of:\n\n* Sodium plasma level of \\>150 mmol\u002FL\n* Potassium plasma level of \\>6.0 mmol\u002FL",{"measure":53,"description":54,"timeFrame":36},"Occurrence of renal failure.","Secondary safety endpoint. Defined as:\n\n* sustained (i.e. \\>28 days) decline in eGFR ≥50% AND\u002FOR\n* reaching end stage renal disease defined as:\n\n  * sustained (i.e. \\>28 days) eGFR \\\u003C15 mL\u002Fmin\u002F1.73 m2\n  * chronic dialysis treatment\n  * receiving a renal transplant AND\u002FOR\n* renal death",{"measure":56,"description":57,"timeFrame":36},"Occurrence of hypersensitivity to investigated drug.","Secondary safety endpoint. Any unexpected adverse drug reaction (UADR).",{"measure":59,"description":60,"timeFrame":36},"Occurrence of allergic reactions.","Secondary safety endpoint. Any hypersensitivity reaction with proven immunological pathomechanism (types I-IV according to Coombs and Gell).",{"measure":62,"description":63,"timeFrame":36},"Occurrence of infection.","Secondary safety endpoint. Any symptomatic infection (viral, bacterial or fungal).",null,{"allocation":66,"interventionModel":67,"interventionModelDescription":64,"primaryPurpose":68,"observationalModel":64,"timePerspective":64,"maskingInfo":69},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":70,"maskingDescription":64,"whoMasked":71},"QUADRUPLE",[72,73,74,75],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","This is a multicentre, randomised, double-blind, placebo-controlled phase III study, evaluating the effect of dapagliflozin versus placebo on prevention of cardiotoxicity in breast cancer patients undergoing anthracycline-based chemotherapy.",[78,84],{"label":79,"type":80,"description":81,"interventionNames":82},"Dapagliflozin","EXPERIMENTAL","Dapagliflozin 10 mg tablet orally once daily for 12 months",[83],"Drug: Dapagliflozin",{"label":85,"type":86,"description":87,"interventionNames":88},"Placebo","PLACEBO_COMPARATOR","Placebo tablet matching dapagliflozin orally once daily for 12 months",[89],"Drug: Placebo",[91,98],{"type":92,"name":79,"description":93,"armGroupLabels":94,"otherNames":95},"DRUG","10 mg tablet q.d",[79],[96,97],"Farxiga","Forxiga",{"type":92,"name":85,"description":99,"armGroupLabels":100,"otherNames":64},"tablet matching dapagliflozin 10 mg q.d",[85],[102],{"name":103,"affiliation":104,"role":105},"Waldemar Banasiak, PhD, MD","4th Military Clinical Hospital with Polyclinic","PRINCIPAL_INVESTIGATOR",[107],{"name":108,"role":109,"phone":110,"phoneExt":64,"email":111},"Bartosz Krakowiak, PhD, MD","CONTACT","+48 261 660 234","bkrakowiak@4wsk.pl",[113,128,137],{"facility":104,"status":114,"city":115,"state":116,"zip":117,"country":118,"countryCode":119,"cosmosGeoPoint":120,"geoPoint":125,"contacts":126},"RECRUITING","Wroclaw","Lower Silesian Voivodeship","50-981","Poland","PL",{"type":121,"coordinates":122},"Point",[123,124],17.03006,51.10286,{"lat":124,"lon":123},[127],{"name":108,"role":109,"phone":110,"phoneExt":64,"email":111},{"facility":129,"status":114,"city":115,"state":116,"zip":130,"country":118,"countryCode":119,"cosmosGeoPoint":131,"geoPoint":133,"contacts":134},"Lower Silesian Centre for Oncology, Lung Diseases and Hematology","53-413",{"type":121,"coordinates":132},[123,124],{"lat":124,"lon":123},[135],{"name":136,"role":109,"phone":64,"phoneExt":64,"email":64},"Rafał Matkowski, PhD, MD",{"facility":138,"status":114,"city":139,"state":140,"zip":141,"country":118,"countryCode":119,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"Military Medical Institute","Warsaw","Masovian Voivodeship","04-141",{"type":121,"coordinates":143},[144,145],21.01178,52.22977,{"lat":145,"lon":144},[148],{"name":149,"role":109,"phone":64,"phoneExt":64,"email":64},"Paweł Krzesiński, PhD, MD",{"type":151,"investigatorFullName":64,"investigatorTitle":64,"investigatorAffiliation":64,"oldNameTitle":64,"oldOrganization":64},"SPONSOR","100539516",false,"NCT06304857","CardioPROTECTion with Dapagliflozin in Breast Cancer Patients Treated with AnthrAcycline - PROTECTAA TRIAL","A Multicentre, Randomised, Double-blind, Placebo-controlled Phase III Study, Evaluating the Effect of Dapagliflozin on Prevention of Cardiotoxicity in Breast Cancer Patients Undergoing Anthracycline-based Chemotherapy","PROTECTAA","Inclusion Criteria:\n\n* Age \\> 18 years and \\\u003C 80 years.\n* Diagnosis of invasive breast cancer \\[stage I-III\\] and planned anthracycline treatment within 60 days.\n* Signed Informed Consent to participate in the study.\n\nExclusion Criteria:\n\n* Urinary tract infection with the need for treatment with an antibiotic 48 hours before the scheduled start of anthracycline treatment.\n* Recognised heart failure or symptoms which, in the opinion of the investigator may be a symptom of undiagnosed heart failure.\n* Left ventricular ejection fraction \\\u003C 50% at the time of the screening.\n* Severe valvular heart disease.\n* A history of clinically significant arrhythmia, including atrial fibrillation regardless of type (at discretion of the investigator).\n* A history of stroke.\n* Cardiomyopathy: congenital, post-inflammatory, toxic, infiltrative (e.g. amyloidosis, sarcoidosis, haemochromatosis), postnatal or hypertrophic.\n* Pulmonary hypertension.\n* Uncontrolled arterial pressure or systolic pressure \\\u003C 80 mmHg at screening (at the discretion of the investigator).\n* BMI \\> 40 kg\u002Fm2.\n* Diagnosed type 1 or type 2 diabetes or fasting glucose ≥ 126 mg\u002Fdl or HbA1C ≥ 6,5% (48 mmol\u002Fmol).\n* Pregnancy or breastfeeding.\n* Lack of compliance to use highly effective method of birth control.\n* Expected or possible treatment with epirubicin or liposomal doxorubicin within 12 months.\n* Taking another study drug or drugs from the group of SGLT2 inhibitors up to 6 months before the screening visit.\n* Taking semaglutide, liraglutide and metformin during the 30 days preceding the screening visit.\n* eGFR \\\u003C 25 ml\u002Fmin\u002F1.73m2 according to CKD EPI.\n* Life expectancy \\\u003C 12 months or cancer disease stage IV according to the TNM classification.\n* Alanine transaminase or aspartate transaminase levels above 2.5 times the local norm.\n* Anemia with Hemoglobin \\\u003C 9 g\u002Fdl.\n* Kidney failure \\> G2 (according to KDIGO classification).\n* Liver disorders, Child-Pugh score \\> 4.\n* Known, active infections with HIV, HBV, HCV, tuberculosis.\n* Any other condition which, in the opinion of the investigator, makes it impossible to fulfill the requirements for participation in this study.","ALL","18 Years","80 Years",{"count":163,"type":164},188,"ESTIMATED","INTERVENTIONAL",[167],"PHASE3","The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of cancer therapeutics-related cardiac dysfunction in patients with breast cancer receiving anthracycline treatment.",[170,171],"Breast Cancer","Heart Failure",[173,174,175,176],"breast cancer","heart failure","ejection fraction","anthracyclines","2024-12-02",{"date":179,"type":180},"2024-12-04","ACTUAL",{"date":182,"type":180},"2024-04-15",{"date":184,"type":164},"2027-12-31",{"name":5,"class":6},3]