[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530273":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":51,"studyPopulation":23,"armGroups":52,"interventions":65,"overallOfficials":74,"centralContacts":78,"locations":84,"responsibleParty":97,"collaborators":23,"id":100,"slug":23,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":101,"sex":107,"minAge":108,"maxAge":23,"enrollmentInfo":109,"targetDuration":23,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":23,"overallStatus":86,"whyStopped":23,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Rijnstate Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"The primary efficacy clinical endpoint of the trial is assessed at 12 months by a 7 point scale. Only the worst clinical outcome will be retained as the primary efficacy outcome","The 7 mutually exclusive outcomes hierarchically ranked from worst to best are:\n\n* Arrhythmic death while using anti-arrhythmic drugs (Vaughn-Williams class I or III)\\*\n* AF despite pulmonary vein isolation\n* AF despite current use of anti-arrhythmic drugs (Vaughn-Williams class I or III)\n* AF without a pulmonary vein isolation and without the current use of anti-arrhythmic drugs (Vaughn-Williams class I or III)\n* Sinus rhythm on the 12-lead ECG with the use of a pulmonary vein isolation\n* Sinus rhythm on the 12-lead ECG with current use of anti-arrhythmic drugs (Vaughn-Williams class I or III)\n* Sinus rhythm on the 12-lead ECG without the current use of anti-arrhythmic drugs (Vaughn-Williams class I or III) and without a pulmonary vein isolation\n\n  * When LTFU or death other than anti-arrhythmic death, last known rhythm will be used.","At 1 year follow-up",[14,18,21,25,27,29,31,33,35,37,39],{"measure":15,"description":16,"timeFrame":17},"Change in AF related symptoms measured by the modified EHRA classification between the index visit and at 12 months after the index visit.","EHRA: European Heart Rythm Association\n\n1= no symptoms 2a= mild symptoms; Normal dialy activity not affected, symptoms not troublesome to patient 2b= moderate symptoms; Normal daily activity not affected but patient troubled by symptoms 3= severe symptoms; Normal daily activity affected 4= disabling symptoms; Normal daily activity discontinued","week 0 and 52",{"measure":19,"description":20,"timeFrame":17},"Change in quality of life measured by the EQ-5D-5L between the index visit and at 12 months after the index visit.","Descriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain \\& discomfort, Anxiety \\& depression), each of which has five severity levels that are described by statements appropriate to that dimension.\n\nLEVEL 1: indicating no problem LEVEL 2: indicating slight problems LEVEL 3: indicating moderate problems LEVEL 4: indicating severe problems LEVEL 5: indicating unable to\u002Fextreme problems",{"measure":22,"description":23,"timeFrame":24},"Number of hospitalizations because of an AF recurrence.",null,"week 0-52",{"measure":26,"description":23,"timeFrame":24},"Number of unscheduled hospital visits because of adverse events of AAD.",{"measure":28,"description":23,"timeFrame":24},"Number of scheduled electrical cardioversions.",{"measure":30,"description":23,"timeFrame":24},"Number of unscheduled electrical cardioversions.",{"measure":32,"description":23,"timeFrame":24},"Number of intravenous chemical cardioversions (using Vaughan-Williams class I drugs).",{"measure":34,"description":23,"timeFrame":24},"Total number of unscheduled cardioverions.",{"measure":36,"description":23,"timeFrame":17},"Change in waist circumference, measured in cm",{"measure":38,"description":23,"timeFrame":17},"Change in weight, measured in % and kg",{"measure":40,"description":23,"timeFrame":17},"Change in BMI, measured in kg\u002Fm2",{"allocation":42,"interventionModel":43,"interventionModelDescription":23,"primaryPurpose":44,"observationalModel":23,"timePerspective":23,"maskingInfo":45},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":46,"maskingDescription":23,"whoMasked":47},"TRIPLE",[48,49,50],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","Rationale: Weight reduction promotes reversed atrial remodeling in obese AF patients.\n\nObjective: Quantify the effect of an innovative weight loss management on rhythm control.\n\nStudy design: Multi-center, double-blind, randomized, parallel group, placebo-controlled trial of semaglutide 2.4 mg versus placebo.\n\nStudy population: Adults with obesity and new onset persistent AF scheduled for electrical cardioversion.\n\nIntervention: semaglutide 2.4 mg subcutaneous (s.c.) once weekly (index) compared to placebo (control), at the background of standard obesity treatment (combined lifestyle intervention) and cardiology follow-up management in both arms.\n\nMain study parameters\u002Fendpoints: The primary efficacy clinical endpoint of the trial is assessed at 12 months by a 7 point scale. Only the worst clinical outcome will be retained as the primary efficacy outcome. The 7 mutually exclusive outcomes hierarchically ranked from worst to best are:\n\n* Arrhythmic death while using anti-arrhythmic drugs (Vaughn-Williams class I or III)\\*\n* AF despite pulmonary vein isolation\n* AF despite current use of anti-arrhythmic drugs (Vaughn-Williams class I or III)\n* AF without a pulmonary vein isolation and without the current use of anti-arrhythmic drugs (Vaughn-Williams class I or III)\n* Sinus rhythm on the 12-lead ECG with the use of a pulmonary vein isolation\n* Sinus rhythm on the 12-lead ECG with current use of anti-arrhythmic drugs (Vaughn-Williams class I or III)\n* Sinus rhythm on the 12-lead ECG without the current use of anti-arrhythmic drugs (Vaughn-Williams class I or III) and without a pulmonary vein isolation\n\n  * When LTFU or death other than anti-arrhythmic death, last known rhythm will be used.",[53,59],{"label":54,"type":55,"description":56,"interventionNames":57},"Intervention","ACTIVE_COMPARATOR","Semaglutide injections + combined lifestyle intervention",[58],"Drug: Semaglutide 3.2 MG\u002FML",{"label":60,"type":61,"description":62,"interventionNames":63},"Placebo","PLACEBO_COMPARATOR","Placebo Semaglutide injections + combined lifestyle intervention",[64],"Drug: Placebo",[66,71],{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":23},"DRUG","Semaglutide 3.2 MG\u002FML","Intervention arm receives semaglutide in addition to combined lifestyle intervention",[54],{"type":67,"name":60,"description":72,"armGroupLabels":73,"otherNames":23},"Control arm receives placebo in addition to combined lifestyle intervention",[60],[75],{"name":76,"affiliation":5,"role":77},"Ron Pisters, dr.","PRINCIPAL_INVESTIGATOR",[79],{"name":80,"role":81,"phone":82,"phoneExt":23,"email":83},"Leonard Voorhout, MSc","CONTACT","+31650818296","lvoorhout@rijnstate.nl",[85],{"facility":5,"status":86,"city":87,"state":88,"zip":23,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":23},"RECRUITING","Arnhem","Gelderland","Netherlands","NL",{"type":92,"coordinates":93},"Point",[94,95],5.91111,51.98,{"lat":95,"lon":94},{"type":77,"investigatorFullName":98,"investigatorTitle":99,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Ron Pisters","Head of Cardioresearch and principal investigator, dr. R. Pisters","100530273",false,"NCT06184633","DUTCH Weight Control in Atrial Fibrillation Study","DUTCH Weight Control in Atrial Fibrillation Study, a Multi-center, Double-blind, Randomized, Parallel Group, Placebo-controlled Trial","DUTCH-WAIST","Inclusion Criteria:\n\n* Symptomatic, first detected (at maximum 6 months prior to enrollment) persistent AF -\n* Age ≥ 18\n* Obesity, as defined as:\n\n  * BMI ≥ 30 kg\u002Fm2, or\n  * BMI ≥27 kg\u002Fm2 with the presence of at least one weight related comorbidity (treated or untreated, e.g. hypertension, dyslipidaemia, obstructive sleep apnea, cardiovascular disease)\n* Scheduled ECV\n* Written informed consent\n\nExclusion Criteria:\n\n* Permanent AF\n* Secondary AF, i.e. due to thyrotoxicosis, infection (e.g. pneumonia) or post-(cardiothoracic) surgery\n* Current or previous treatment with amiodaron\n* HbA1c ≥ 48 mmol\u002FL, \\\u003C3 months prior to randomization\n* History of diabetes mellitus type 1 or 2\n* Prior bariatric surgery\n* Use of other anti-obesity medication, \\\u003C3 months prior to enrollment\n* Contra-indication for, or prior use of a GLP1-receptor agonist\n* History of chronic pancreatitis or acute pancreatitis \\\u003C6 months\n* Acute coronary syndrome \\\u003C6 months\n* Severe (grade III) valvular disease\n* eGFR \\\u003C30 mL\u002Fmin\u002F1.73m2\n* Heart failure NYHA class III-IV\n* Participation in another investigational drug or device study in the past 30 days (registry enrollment is allowed)\n* Any condition or therapy, which would make the participant unsuitable for the study (e.g. vulnerable, non-compliance) or life-expectancy \\\u003C12 months, as judged by the treating physician.\n* Female who is pregnant, breastfeeding, intends to become pregnant, or is of child-bearing potential and not using a highly effective contraceptive method.","ALL","18 Years",{"count":110,"type":111},280,"ESTIMATED","INTERVENTIONAL",[114],"PHASE4","Quantify the effect of an innovative weight loss management on rhythm control.",[117,118,119],"Atrial Fibrillation","Obesity","Weight Loss","2024-09-09",{"date":122,"type":123},"2024-09-19","ACTUAL",{"date":125,"type":123},"2024-07-21",{"date":127,"type":111},"2027-05-01",{"name":5,"class":6},1]