[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555206":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":31,"locations":36,"responsibleParty":55,"collaborators":58,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":17,"enrollmentInfo":71,"targetDuration":17,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":82,"overallStatus":92,"whyStopped":17,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Spanish Society of Cardiology","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Beta-blockers","EXPERIMENTAL","Beta-blockers with alpha or NO activity will be used. Dosage according to responsible physician and current clinical practice",[13],"Drug: Beta blocker",{"label":15,"type":16,"description":15,"interventionNames":17},"No beta-blockers","NO_INTERVENTION",null,[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Beta blocker","Pragmatic design. Any beta-blocker with alpha or NO activity may be used",[9],[25],"Other medications according to local clinical practice protocols and current guidelines",[27],{"name":28,"affiliation":29,"role":30},"Fernando Alfonso, MD","Hospital Universitario La Princesa, Madrid. IIS-IP","STUDY_CHAIR",[32],{"name":28,"role":33,"phone":34,"phoneExt":17,"email":35},"CONTACT","34 680483165","falf@hotmail.com",[37],{"facility":38,"status":17,"city":39,"state":17,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Hospital Universitario de la Princesa","Madrid","28006","Spain","ES",{"type":44,"coordinates":45},"Point",[46,47],-3.70256,40.4165,{"lat":47,"lon":46},[50,51,53],{"name":28,"role":33,"phone":34,"phoneExt":17,"email":35},{"name":28,"role":52,"phone":17,"phoneExt":17,"email":17},"PRINCIPAL_INVESTIGATOR",{"name":54,"role":52,"phone":17,"phoneExt":17,"email":17},"Jorge Salamanca, MD",{"type":52,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"Fernando Alfonso","Head Cardiac Department",[59],{"name":60,"class":6},"Fundación de Investigación Biomédica - Hospital Universitario de La Princesa","100555206","phase-4-beta-blockers-in-takotsubo-syndrome-study-100555206",false,"NCT06509074","Beta-Blockers in Takotsubo Syndrome Study","Beta-Blockers in Takotsubo Syndrome Study: A Randomized Clinical Trial (β-Tako)","β-Tako","Inclusion Criteria:\n\n* Written informed consent.\n* Diagnosis of TTS with exclusion of significant coronary artery disease (CAD) by invasive coronary angiography\n\nExclusion Criteria:\n\n* Patients diagnosed of TTS \\> 48 hours before.\n* Persistent ccardiogenic shock or severe hemodynamic instability\n* Persistent severe (\\>30 mmHg) intraventricular gradient\n* Previous diagnosis of severe valvular or ventricular disease or prior myocardial infarction secondary to atherosclerotic CAD\n* Patients already receiving treatment with betablockers (\\*)\n* Absolute contraindication\u002Findication for beta-blockers (\\*\\*)\n* Poor echocardiographic window\n* Pregnant or breastfeeding women.\n* Participation in another clinical trial.\n\n(\\*) Betablockers at a therapeutic dose at the time of symptom´s onset. (\\*\\*) Close ECG monitoring required in patients with hypotension, bradycardia or cQT interval prolongation","ALL","18 Years",{"count":72,"type":73},200,"ESTIMATED","INTERVENTIONAL",[76],"PHASE4","The Beta-blockers in Takotsubo syndrome (TTS) (β-Tako) trial, is an academic, pragmatic, prospective, multicenter randomized clinical trial, aiming to assess the efficacy of beta-blockers (BB) in TTS patients. Two-hundred patients with TTS will be randomized (1:1) to BB (n=100) or no BB (n=100). BB with alpha or nitric oxide release activity will be used in the treatment arm. The primary endpoint will be the comparison of the wall motion score index by echocardiography at 7 days. A composite clinical endpoint (death, stroke, admission for recurrent TTS, ACS, heart failure or atrial fibrillation) at 1 year, will be assessed by an independent clinical events committee. Several sub-studies will be performed. The β-Tako trial will inform treatment decisions in this uniquely challenging clinical entity.",[79,9,80,81],"Takotsubo Cardiomyopathy","Echocardiography","Left Ventricular Function",[79,83,84,85,86,87,88,89,90,91],"beta-blockers","echocardiography","left ventricular function","acute myocardial infarction","acute coronary syndrome","coronary angiography","Normal coronary arteries","Heart failure","stress","NOT_YET_RECRUITING","2024-08-21",{"date":95,"type":96},"2024-08-26","ACTUAL",{"date":98,"type":73},"2024-08",{"date":100,"type":73},"2026-12",{"name":5,"class":6},1]