[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569475":3},{"organization":4,"outcomesModule":7,"designInfo":91,"detailedDescription":103,"studyPopulation":11,"armGroups":104,"interventions":124,"overallOfficials":134,"centralContacts":139,"locations":148,"responsibleParty":167,"collaborators":171,"id":175,"slug":11,"hasResults":176,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":176,"sex":182,"minAge":183,"maxAge":11,"enrollmentInfo":184,"targetDuration":11,"studyType":187,"phases":188,"briefSummary":190,"conditions":191,"keywords":193,"overallStatus":150,"whyStopped":11,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":209,"completionDateStruct":210,"leadSponsor":212,"locationsCount":213},{"fullName":5,"class":6},"Herlev and Gentofte Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Time to the first occurrence of hospitalization for heart failure or cardiovascular death",null,"From date of randomization until end of study (Up to approximately 33 months)",[14,16],{"measure":15,"description":11,"timeFrame":12},"Time to first occurrence of hospitalization for heart failure",{"measure":17,"description":11,"timeFrame":12},"Time to cardiovascular death",[19,21,23,25,27,29,31,33,35,37,39,41,43,45,47,49,51,54,57,59,61,63,65,67,69,71,73,75,77,79,81,83,85,87,89],{"measure":20,"description":11,"timeFrame":12},"Total number of hospitalizations for heart failure",{"measure":22,"description":11,"timeFrame":12},"Total number of hospitalizations for heart failure and cardiovascular death",{"measure":24,"description":11,"timeFrame":12},"Time to the first occurrence of hospitalization for heart failure or all-cause death",{"measure":26,"description":11,"timeFrame":12},"Total number of hospitalizations for heart failure and all-cause death",{"measure":28,"description":11,"timeFrame":12},"Time to all-cause mortality",{"measure":30,"description":11,"timeFrame":12},"Time to first occurrence of major adverse cardiovascular events",{"measure":32,"description":11,"timeFrame":12},"Total number of major adverse cardiovascular events",{"measure":34,"description":11,"timeFrame":12},"Time to first occurrence of hospitalization for any cardiovascular disease",{"measure":36,"description":11,"timeFrame":12},"Total number of hospitalizations for any cardiovascular disease",{"measure":38,"description":11,"timeFrame":12},"Time to first occurrence of hospitalization for any cardiorespiratory disease",{"measure":40,"description":11,"timeFrame":12},"Total number of hospitalizations for any cardiorespiratory disease",{"measure":42,"description":11,"timeFrame":12},"Time to first hospitalization for atrial fibrillation",{"measure":44,"description":11,"timeFrame":12},"Total number of hospitalizations for atrial fibrillation",{"measure":46,"description":11,"timeFrame":12},"Time to first occurrence of hospitalization for cardiac arrest",{"measure":48,"description":11,"timeFrame":12},"Time to first hospitalization for any cause",{"measure":50,"description":11,"timeFrame":12},"Total number of hospitalizations for any cause",{"measure":52,"description":11,"timeFrame":53},"Change in Kansas City Cardiomyopathy Questionnaire Score","Aproximately within 1 year after randomization",{"measure":55,"description":56,"timeFrame":53},"Change in left ventricular ejection fraction assessed with echocardiography","In up to 600 participants in a planned substudy with two physical visits. One shortly after randomization and another 1 year after",{"measure":58,"description":56,"timeFrame":53},"Change in left ventricular global longitudinal strain assessed with echocardiography",{"measure":60,"description":56,"timeFrame":53},"Change in E\u002Fe'-ratio assessed with echocardiography",{"measure":62,"description":56,"timeFrame":53},"Change in left ventricular mass assessed with echocardiography",{"measure":64,"description":56,"timeFrame":53},"Change in interventricular septal wall thickness assessed with echocardiography",{"measure":66,"description":56,"timeFrame":53},"Change in left ventricular posterior thickness assessed with echocardiography",{"measure":68,"description":56,"timeFrame":53},"Change in left atrial volume assessed with echocardiography",{"measure":70,"description":56,"timeFrame":53},"Change in left atrial resevoir strain assessed with echocardiography",{"measure":72,"description":56,"timeFrame":53},"Change in left atrial contraction strain assessed with echocardiography",{"measure":74,"description":56,"timeFrame":53},"Change in left atrial conduit strain assessed with echocardiography",{"measure":76,"description":56,"timeFrame":53},"Change in tricuspid annular plane systolic excursion assessed with echocardiography",{"measure":78,"description":56,"timeFrame":53},"Change in right ventricular free wall longitudinal strain assessed with echocardiography",{"measure":80,"description":56,"timeFrame":53},"Change in pro-BNP",{"measure":82,"description":56,"timeFrame":53},"Change in high sensitivity troponin-I",{"measure":84,"description":56,"timeFrame":53},"Change in hs-CRP",{"measure":86,"description":56,"timeFrame":53},"Concentration of coenzyme Q10 at followup",{"measure":88,"description":56,"timeFrame":53},"Concentration of selenoprotein P and selenium at followup",{"measure":90,"description":56,"timeFrame":53},"Change in 6 minute walking distance",{"allocation":92,"interventionModel":93,"interventionModelDescription":94,"primaryPurpose":95,"observationalModel":11,"timePerspective":11,"maskingInfo":96},"RANDOMIZED","FACTORIAL","Participants will be randomized in a 1:1 fashion to receive either the experimental intervention or placebo for each of the two nutritional supplements.","TREATMENT",{"masking":97,"maskingDescription":11,"whoMasked":98},"QUADRUPLE",[99,100,101,102],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","This investigator-initiated, pragmatic, registry-based, double-blinded, placebo-controlled, 2x2 factorial, individually randomized trial aims to evaluate the efficacy of daily intake of the nutritional supplements coenzyme Q10 versus placebo, and selenium versus placebo, in preventing heart failure hospitalizations and cardiovascular death in heart failure patients. The trial plans to randomize approximately 4,044 participants in an event-driven design. Participants will be identified through the Danish Administrative Health Registries, which will also serve as the primary source for data collection. Contact with potential participants will be made via the mandatory Danish electronic letter system. No scheduled in-person visits are required in the main study, and all study interventions will be mailed to participants.\n\nA substudy involving up to 600 participants will assess the effects of coenzyme Q10 and selenium on functional capacity, treatment compliance, biochemical biomarkers, and cardiac function and structure. This group will attend two in-person visits for additional evaluations, including echocardiography, blood sampling, and a 6-minute walk test at baseline and at the 1-year follow-up.",[105,111,116,121],{"label":106,"type":107,"description":108,"interventionNames":109},"Coenzyme Q10 intervention, active","EXPERIMENTAL","100 mg capsules given twice daily, per oral use",[110],"Dietary Supplement: Coenzyme Q10 100 Milligrams Oral Capsule",{"label":112,"type":113,"description":114,"interventionNames":115},"Coenzyme Q10 intervention, placebo","PLACEBO_COMPARATOR","Placebo matching coenzyme Q10",[110],{"label":117,"type":107,"description":118,"interventionNames":119},"Selenium intervention, active","100 μg tables given twice daily, per oral use",[120],"Dietary Supplement: Selenium 100 Micrograms Oral Tablets",{"label":122,"type":113,"description":118,"interventionNames":123},"Selenium intervention, placebo",[120],[125,130],{"type":126,"name":127,"description":128,"armGroupLabels":129,"otherNames":11},"DIETARY_SUPPLEMENT","Coenzyme Q10 100 Milligrams Oral Capsule","100 mg capsules given twice daily, per oral use.",[106,112],{"type":126,"name":131,"description":132,"armGroupLabels":133,"otherNames":11},"Selenium 100 Micrograms Oral Tablets","100 μg tablets given twice daily, per oral use.",[117,122],[135],{"name":136,"affiliation":137,"role":138},"Tor Biering-Sørensen, MD, MPH, MSc, PhD","Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte","PRINCIPAL_INVESTIGATOR",[140,145],{"name":141,"role":142,"phone":143,"phoneExt":11,"email":144},"Kristoffer G Skaarup, MD","CONTACT","+4542451250","kristoffer.grundtvig.skaarup@regionh.dk",{"name":136,"role":142,"phone":146,"phoneExt":11,"email":147},"+4528933590","tor.biering-soerensen@regionh.dk",[149],{"facility":137,"status":150,"city":151,"state":11,"zip":152,"country":153,"countryCode":154,"cosmosGeoPoint":155,"geoPoint":160,"contacts":161},"RECRUITING","Hellerup","2900","Denmark","DK",{"type":156,"coordinates":157},"Point",[158,159],12.57093,55.73204,{"lat":159,"lon":158},[162,163,166],{"name":141,"role":142,"phone":143,"phoneExt":11,"email":144},{"name":164,"role":142,"phone":11,"phoneExt":11,"email":165},"Sine H Christensen, MSc","sine.hoejlund.christensen@regionh.dk",{"name":136,"role":138,"phone":11,"phoneExt":11,"email":11},{"type":168,"investigatorFullName":169,"investigatorTitle":170,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Tor Biering-Sørensen","Professor, MD, MSc, MPH, PhD",[172],{"name":173,"class":174},"Pharma Nord","INDUSTRY","100569475",false,"NCT06694727","A Danish Pragmatic Randomized Trial of Nutritional Supplements in Heart Failure","A Danish Pragmatic Randomized Trial of Nutritional Supplements in Heart Failure (DANUTRIO-HF: Q10, DANUTRIO-HF: Selenium)","DANUTRIO-HF","Inclusion Criteria:\n\n* Individuals aged ≥ 18 years.\n* Registered with a heart failure diagnosis (ICD-10: I50) as a primary discharge diagnosis in The Danish National Patient Registry and at least one claimed prescription of a renin-angiotensin-system inhibitor and a β-blocker within 120 days after HF diagnosis.\n* Informed consent form has been signed and dated.\n\nExclusion Criteria:\n\n* Use of vitamin K-antagonist\n* Registered with a cancer diagnosis (C00-C97 not C44) within the last 5 years excluding cutaneous squamous cell or basal cell carcinoma in The Danish National Patient Registry.","ALL","18 Years",{"count":185,"type":186},4044,"ESTIMATED","INTERVENTIONAL",[189],"PHASE3","Heart failure is a common and serious condition. Despite rapid advancements in heart failure treatment, the prognosis remains severe. Smaller studies have shown that two simple, safe, and relatively inexpensive nutritional supplements-coenzyme Q10 and selenium-may reduce the risk of complications associated with heart failure. The DANUTRIO-HF trial will investigate whether these supplements can make a difference for individuals with heart failure. The study will assign approximately 4,044 patients from across Denmark to either coenzyme Q10 (100 mg twice daily) or a corresponding placebo, as well as selenium (100 μg twice daily) or its corresponding placebo, and follow how many of them end up being hospitalized for heart failure or dying from heart problems over an estimated two to three-year period.",[192],"Heart Failure",[194,195,196,197,198,199,200,201,202,203,204],"Heart failure","Coenzyme Q10","Selenium","Randomized Controlled Trial","Registry","Echocardiography","Pragmatic","Factorial","2x2","Cardiovascular","Nutritional supplements","2025-09-30",{"date":207,"type":208},"2025-10-03","ACTUAL",{"date":205,"type":208},{"date":211,"type":186},"2029-06-01",{"name":169,"class":6},1]