[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653796":3},{"organization":4,"outcomesModule":7,"designInfo":71,"detailedDescription":70,"studyPopulation":74,"armGroups":75,"interventions":81,"overallOfficials":70,"centralContacts":90,"locations":96,"responsibleParty":103,"collaborators":105,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":113,"sex":119,"minAge":120,"maxAge":70,"enrollmentInfo":121,"targetDuration":70,"studyType":124,"phases":70,"briefSummary":125,"conditions":126,"keywords":70,"overallStatus":99,"whyStopped":70,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"Bayer","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":70},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Patient Reported Outcome Measure: Amylo-AFFECT-QOL score","Change from baseline in Amylo-AFFECT-QOL total score","At 3, 6, 9, and 12 months after initiation of acoramidis",{"measure":14,"description":15,"timeFrame":12},"Patient Reported Outcome Measure: KCCQ-23 score","Change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ-23) total score",{"measure":17,"description":18,"timeFrame":12},"Patient Reported Outcome Measure: EQ-5D-3L index score","3L index score of EQ-5D Health-Related Quality of Life Questionnaire",{"measure":20,"description":21,"timeFrame":12},"Patient Reported Outcome Measure: EQ VAS score","Visual Analog scale score of EQ-5D Health-Related Quality of Life Questionnaire",[23,27,30,33,36,39,42,46,50,54,57,60,63,66],{"measure":24,"description":25,"timeFrame":26},"Demographic characteristics: Age","Age of patients initiating treatment with acoramidis","Before treatment with acoramidis",{"measure":28,"description":29,"timeFrame":26},"Demographic characteristics: Sex","Sex of patients initiating treatment with acoramidis",{"measure":31,"description":32,"timeFrame":26},"Demographic characteristics: Body Mass Index","Body Mass Index of patients initiating treatment with acoramidis",{"measure":34,"description":35,"timeFrame":26},"Clinical characteristics: Time between diagnosis and treatment initiation","Time between ATTR-CM diagnosis and treatment initiation",{"measure":37,"description":38,"timeFrame":26},"Clinical characteristics: ATTR-CM diagnosis","ATTR-CM diagnosis (genetic status including mutation type \\[if applicable\\], phenotype)",{"measure":40,"description":41,"timeFrame":26},"Clinical characteristics: ATTR-CM manifestations","ATTR-CM manifestations prior to treatment initiation",{"measure":43,"description":44,"timeFrame":45},"Clinical characteristics: Comorbidities","ATTR-CM-relevant comorbidities that were either ongoing at treatment initiation, or were previously managed or resolved in the 12 months prior to initiating acoramidis, as well as those that began after initiating acoramidis","Up to 12 months before initiation of acoramidis, and during treatment with acoramidis",{"measure":47,"description":48,"timeFrame":49},"Clinical characteristics: Prior medication and procedures","Prior medication taken and procedures performed up to 12 months before initiation of acoramidis","Up to 12 months before initiation of acoramidis",{"measure":51,"description":52,"timeFrame":53},"Treatment patterns: Treatment duration","Duration of treatment with acoramidis","During treatment with acoramidis",{"measure":55,"description":56,"timeFrame":53},"Treatment patterns: Treatment interruptions","Proportion of patients with temporary treatment interruptions and reason for interruption",{"measure":58,"description":59,"timeFrame":53},"Treatment patterns: Treatment discontinuation","Proportion of patients with permanent treatment discontinuation and reason for discontinuation",{"measure":61,"description":62,"timeFrame":53},"Treatment patterns: Time to treatment discontinuation","Time to acoramidis treatment discontinuation",{"measure":64,"description":65,"timeFrame":53},"Treatment patterns: Concomitant medications and procedures","Concomitant medications taken and procedures performed during treatment with acoramidis",{"measure":67,"description":68,"timeFrame":69},"Safety and tolerability: Adverse events","Adverse events (AEs) occurring during treatment with acoramidis and AEs occurring up to 6 days after the last intake of acoramidis if premature permanent treatment discontinuation","During treatment with acoramidis and up to 6 days after the last intake of acoramidis in case of premature permanent treatment discontinuation",null,{"allocation":70,"interventionModel":70,"interventionModelDescription":70,"primaryPurpose":70,"observationalModel":72,"timePerspective":73,"maskingInfo":70},"OTHER","PROSPECTIVE","Participants will be recruited from centers that are part of the French Amyloidosis Network or centers that are knowledgeable in the diagnosis and management of transthyretin amyloid cardiomyopathy (ATTR-CM). There are two complementary enrollment pathways: (i) direct recruitment within this study, and (ii) integration of data from the Healthcare Amyloidosis European Registry (HEAR), a multicenter registry maintained by reference centers (see NCT05101304), to enrich the study database.",[76],{"label":77,"type":70,"description":78,"interventionNames":79},"Single Arm","Patients will receive acoramidis 712 mg orally BID (twice daily)",[80],"Drug: Acoramidis",[82],{"type":83,"name":84,"description":85,"armGroupLabels":86,"otherNames":87},"DRUG","Acoramidis","356 mg film-coated tablets. The recommended dose is 712 mg (two tables, 356 mg) orally twice daily, corresponding to a total daily dose of 1424 mg.",[77],[88,89],"BAY3684938","BEYONTTRA",[91],{"name":92,"role":93,"phone":94,"phoneExt":70,"email":95},"Bayer Clinical Trials Contact","CONTACT","4930300139003","clinical-trials-contact@bayer.com",[97],{"facility":98,"status":99,"city":100,"state":70,"zip":70,"country":101,"countryCode":102,"cosmosGeoPoint":70,"geoPoint":70,"contacts":70},"Many locations","RECRUITING","Many Locations","France","FR",{"type":104,"investigatorFullName":70,"investigatorTitle":70,"investigatorAffiliation":70,"oldNameTitle":70,"oldOrganization":70},"SPONSOR",[106,109],{"name":107,"class":108},"Saving Lives Matters","NETWORK",{"name":110,"class":72},"Heart's Foundation","100653796","study-of-acoramidis-in-patients-with-transthyretin-amyloid-cardiomyopathy-100653796",false,"NCT07791160","Study of Acoramidis in Patients With Transthyretin Amyloid Cardiomyopathy","A Prospective, Longitudinal, Multi-center, Observational Study of Acoramidis In Patients With Wild-type or Variant Transthyretin Amyloid Cardiomyopathy (ATTR-CM): MOSAIC-TTR Study","MOSAIC-TTR","Inclusion Criteria:\n\n* Greater than or equal to 18 years of age\n* Established diagnosis of ATTR-CM with either wild-type TTR or a variant TTR genotype\n* Initiating treatment with acoramidis with the decision to treat having been made by the treating physician prior to study enrolment in accordance with the current French Summary of Product Characteristics (SmPC)\n\nExclusion Criteria:\n\n* Any contraindications as listed in the local approved product information\n* Prior treatment with disease-modifying treatment (e.g., tafamidis, TTR silencers and\u002For depleters)\n* Participation in an investigational trial evaluating new Investigational Medicinal Products or new Investigational Medical Device outside of routine clinical practice\n* Under legal protection (guardianship, curatorship, or other legal protection measures) or deprived of liberty by administrative or judicial decision at the time of inclusion.","ALL","18 Years",{"count":122,"type":123},500,"ESTIMATED","OBSERVATIONAL","Transthyretin amyloid cardiomyopathy (ATTR-CM) is a progressive heart disease caused by the buildup of an abnormal protein, called transthyretin (TTR), in the heart. This buildup can make it harder for the heart to pump blood and may lead to worsening symptoms over time. Acoramidis is a medicine approved for the treatment of adults with wild-type or hereditary (variant) ATTR-CM. While its benefits have been demonstrated in clinical trials, more information is needed about how it is used and how patients do in everyday medical practice.\n\nThe MOSAIC-TTR study is an observational study in France. Participants will receive acoramidis as part of their usual medical care. No experimental treatments or additional medical procedures will be required. The study will collect information directly from participating hospitals and from the Healthcare European Amyloidosis Registry (HEAR; NCT05101304). The main goal of the study is to understand how patients' quality of life, daily functioning, and overall well-being change during the first 12 months of treatment with acoramidis, using questionnaires completed by the patients themselves. The study will also collect information about the characteristics of patients receiving acoramidis, how the medicine is used in routine clinical practice, and its safety and tolerability. The information collected will help improve the understanding of ATTR-CM and may help improve the care of people living with this condition.",[127],"Transthyretin Amyloid Cardiomyopathy (ATTR-CM)","2026-09-14",{"date":130,"type":131},"2026-09-15","ACTUAL",{"date":133,"type":131},"2026-09-07",{"date":135,"type":123},"2028-12-31",{"name":5,"class":6},1]