[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615856":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":22,"locations":28,"responsibleParty":217,"collaborators":21,"id":219,"slug":220,"hasResults":221,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":225,"eligibilityCriteria":226,"healthyVolunteers":221,"sex":227,"minAge":228,"maxAge":229,"enrollmentInfo":230,"targetDuration":21,"studyType":233,"phases":234,"briefSummary":236,"conditions":237,"keywords":239,"overallStatus":45,"whyStopped":21,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":250},{"fullName":5,"class":6},"Bayer","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Acoramidis","EXPERIMENTAL","Participants will receive acoramidis 712 mg orally BID",[13],"Drug: Acoramidis",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","356 mg film-coated tablets.\n\nThe recommended dose of acoramidis is 712 mg (two tablets, 356 mg) orally, twice daily, corresponding to a total daily dose of 1424 mg.",[9],[20],"BAY3684938, BEYONTTRA",null,[23],{"name":24,"role":25,"phone":26,"phoneExt":21,"email":27},"Bayer Clinical Trials Contact","CONTACT","(+)1-888-84 22937","clinical-trials-contact@bayer.com",[29,43,54,61,67,71,81,91,103,113,125,136,145,154,163,172,181,190,199,208],{"facility":30,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":21},"Universitätsklinikum St. Pölten - Lilienfeld - Klinische Abteilung für Innere Medizin 3","WITHDRAWN","Sankt Pölten","Lower Austria","1210","Austria","AT",{"type":38,"coordinates":39},"Point",[40,41],15.63725,48.20762,{"lat":41,"lon":40},{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":35,"countryCode":36,"cosmosGeoPoint":49,"geoPoint":53,"contacts":21},"Medizinische Universität Wien- Universitätsklinik für Innere Medizin II, Klinische Abteilung für Kardiologie","RECRUITING","Vienna","State of Vienna","1090",{"type":38,"coordinates":50},[51,52],16.37208,48.20849,{"lat":52,"lon":51},{"facility":55,"status":56,"city":46,"state":47,"zip":57,"country":35,"countryCode":36,"cosmosGeoPoint":58,"geoPoint":60,"contacts":21},"Klinik Favoriten - 5.Medizinische Abteilung-Kardiologie","NOT_YET_RECRUITING","1100",{"type":38,"coordinates":59},[51,52],{"lat":52,"lon":51},{"facility":62,"status":56,"city":46,"state":47,"zip":63,"country":35,"countryCode":36,"cosmosGeoPoint":64,"geoPoint":66,"contacts":21},"Klinik Ottakring - 3. Medizinische Abteilung mit Kardiologie, internistischer Intensivmedizin und Ambulanz","3500",{"type":38,"coordinates":65},[51,52],{"lat":52,"lon":51},{"facility":68,"status":45,"city":46,"state":69,"zip":70,"country":35,"countryCode":36,"cosmosGeoPoint":21,"geoPoint":21,"contacts":21},"Medizinische Universität Graz- Klinische Abteilung für Kardiologie","Styria","1030",{"facility":72,"status":56,"city":73,"state":74,"zip":75,"country":35,"countryCode":36,"cosmosGeoPoint":76,"geoPoint":80,"contacts":21},"Krankenhaus St. Josef Braunau | Innere Medizin I","Braunau am Inn","Upper Austria","5280",{"type":38,"coordinates":77},[78,79],13.04343,48.25628,{"lat":79,"lon":78},{"facility":82,"status":31,"city":83,"state":84,"zip":85,"country":35,"countryCode":36,"cosmosGeoPoint":86,"geoPoint":90,"contacts":21},"VIVIT - Landeskrankenhaus Feldkirch - Innere Medizin I, Kardiologie, Angiologie, Endokrinologie, Diabetologie, Intensivmedizin","Feldkirch","Vorarlberg","6800",{"type":38,"coordinates":87},[88,89],9.59734,47.23645,{"lat":89,"lon":88},{"facility":92,"status":56,"city":93,"state":94,"zip":95,"country":96,"countryCode":97,"cosmosGeoPoint":98,"geoPoint":102,"contacts":21},"Hôpital Erasme\u002FErasmus Ziekenhuis","Brussels","Brussels Capital","1070","Belgium","BE",{"type":38,"coordinates":99},[100,101],4.34878,50.85045,{"lat":101,"lon":100},{"facility":104,"status":56,"city":105,"state":106,"zip":107,"country":96,"countryCode":97,"cosmosGeoPoint":108,"geoPoint":112,"contacts":21},"AZ St-Jan Brugge-Oostende A.V.","Bruges","West Flanders","8000",{"type":38,"coordinates":109},[110,111],3.22424,51.20892,{"lat":111,"lon":110},{"facility":114,"status":56,"city":115,"state":116,"zip":117,"country":118,"countryCode":119,"cosmosGeoPoint":120,"geoPoint":124,"contacts":21},"KVZ Kardiovaskulaeres Zentrum Darmstadt GmbH","Darmstadt","Hesse","64287","Germany","DE",{"type":38,"coordinates":121},[122,123],8.65027,49.87167,{"lat":123,"lon":122},{"facility":126,"status":45,"city":127,"state":21,"zip":128,"country":129,"countryCode":130,"cosmosGeoPoint":131,"geoPoint":135,"contacts":21},"Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII - Cardiologia 1","Bergamo","24127","Italy","IT",{"type":38,"coordinates":132},[133,134],9.66721,45.69601,{"lat":134,"lon":133},{"facility":137,"status":56,"city":138,"state":21,"zip":139,"country":129,"countryCode":130,"cosmosGeoPoint":140,"geoPoint":144,"contacts":21},"Azienda Ospedaliero-Universitaria Di Bologna IRCCS_Policlinico Sant'Orsola_Cardiologia","Bologna","40138",{"type":38,"coordinates":141},[142,143],11.33875,44.49381,{"lat":143,"lon":142},{"facility":146,"status":56,"city":147,"state":21,"zip":148,"country":129,"countryCode":130,"cosmosGeoPoint":149,"geoPoint":153,"contacts":21},"Careggi University Hospital_cardio intensive care unit","Florence","50134",{"type":38,"coordinates":150},[151,152],11.24626,43.77925,{"lat":152,"lon":151},{"facility":155,"status":56,"city":156,"state":21,"zip":157,"country":129,"countryCode":130,"cosmosGeoPoint":158,"geoPoint":162,"contacts":21},"Ospedale Vito Fazzi Lecce_Cardiologia e UTIC","Lecce","73100",{"type":38,"coordinates":159},[160,161],18.17244,40.35481,{"lat":161,"lon":160},{"facility":164,"status":45,"city":165,"state":21,"zip":166,"country":129,"countryCode":130,"cosmosGeoPoint":167,"geoPoint":171,"contacts":21},"Centro Cardiologico Monzino S.p.A. - Cardiologia Peri-Operatoria e Imaging Cardiovascolare","Milan","20138",{"type":38,"coordinates":168},[169,170],12.59836,42.78235,{"lat":170,"lon":169},{"facility":173,"status":56,"city":174,"state":21,"zip":175,"country":129,"countryCode":130,"cosmosGeoPoint":176,"geoPoint":180,"contacts":21},"Azienda Ospedaliera Dei Colli_Monaldi - Malattie Rare e Genetiche Cardiovascolari","Naples","80131",{"type":38,"coordinates":177},[178,179],14.26811,40.85216,{"lat":179,"lon":178},{"facility":182,"status":56,"city":183,"state":21,"zip":184,"country":129,"countryCode":130,"cosmosGeoPoint":185,"geoPoint":189,"contacts":21},"Azienda Ospedale-Università di Padova-UOC Cardiologia","Padova","35128",{"type":38,"coordinates":186},[187,188],11.14261,44.38225,{"lat":188,"lon":187},{"facility":191,"status":56,"city":192,"state":21,"zip":193,"country":129,"countryCode":130,"cosmosGeoPoint":194,"geoPoint":198,"contacts":21},"Fondazione IRCCS Policlinico San Matteo-SC Medicina Generale 2 - Centro Amiloidosi Sistemiche e Malattie ad Alta Complessità","Pavia","27100",{"type":38,"coordinates":195},[196,197],9.15917,45.19205,{"lat":197,"lon":196},{"facility":200,"status":45,"city":201,"state":21,"zip":202,"country":129,"countryCode":130,"cosmosGeoPoint":203,"geoPoint":207,"contacts":21},"Fondazione Toscana Gabriele Monasterio_Pisa - Cardiologia e Medicina Cardiovascolare","Pisa","56124",{"type":38,"coordinates":204},[205,206],10.4036,43.70853,{"lat":206,"lon":205},{"facility":209,"status":45,"city":210,"state":21,"zip":211,"country":129,"countryCode":130,"cosmosGeoPoint":212,"geoPoint":216,"contacts":21},"Azienda Ospedaliera Universitaria Senese - cardiologia","Siena","53100",{"type":38,"coordinates":213},[214,215],11.33064,43.31822,{"lat":215,"lon":214},{"type":218,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100615856","phase-4-a-study-to-learn-more-about-the-change-in-the-blood-levels-of-transthyretin-when-participants-with-transthyretin-amyloidosis-with-cardiomyopathy-switch-from-tafamidis-to-acoramidis-100615856",false,"NCT07298044","A Study to Learn More About the Change in the Blood Levels of Transthyretin When Participants With Transthyretin Amyloidosis With Cardiomyopathy Switch From Tafamidis to Acoramidis","A Prospective, Single-arm, Phase 4 Study to Evaluate the Course of Serum Transthyretin (TTR) Level With Acoramidis in Adult Patients With Variant or Wild-type Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM) Previously Treated With Tafamidis","ACO-SWITCH","Inclusion Criteria:\n\n* Participants must be 18 to 90 years of age inclusive, at the time of signing the informed consent.\n* Diagnosis of ATTR-CM; disease defining examination, i.e., Single Photon Emission Computed Tomography (SPECT) or SPECT\u002FComputed Tomography (CT) or biopsy, within 24 months prior to Visit 1 (V1).\n* Participants must currently be treated with tafamidis and have used tafamidis for at least the previous 3 months prior to V1 and have adhered to tafamidis therapy.\n* New York Heart Association (NYHA) class ≤ II at V1.\n* Estimate glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin\u002F1.73m\\^2 at V1.\n* N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) \\> 300 and ≤ 7000 pg\u002FmL at V1.\n\nExclusion Criteria:\n\n* Prior liver or heart transplantation or planned within the next 12 months.\n* Current or planned use of ventricular assist device.\n* Active cancer or other disease that decreases the life expectancy to less than one year.\n* Heart failure due to ischemic heart disease.\n* Myocardial infarction, cardiovascular (CV) surgery, or unstable angina within the last 90 days prior to V1.\n* Confirmed diagnosis of light-chain amyloidosis.\n* Dialysis or severe renal impairment as reflected by Urinary Albumin Creatinine Ratio (UACR) \\> 300 mg\u002Fg at V1.\n* Major surgery 90 days prior to V1.\n* Recent initiation of Sodium-Glucose-Cotransporter-2 inhibitors (SGLT2i) within 3 months before V1.\n* Initiation of treatment with a diuretic or increase in diuretic dose within 3 months before V1.\n* Treatment with calcium channel blockers (e.g., verapamil, diltiazem) or digitalis.\n* Recent CV hospitalization within 3 months before V1.\n* Known hypersensitivity to acoramidis or to any of the excipients.\n* A condition that, as judged by the investigator, would preclude compliance with the study protocol, such as a history of substance abuse, alcoholism, or a psychiatric condition.\n* Known or suspected liver disorder and bile secretion\u002Fflow (cholestasis, also history of it).\n* Abnormal liver function tests at V1, defined as ALT (GPT) or AST (GOT) ≥ 3 x ULN or total bilirubin ≥ 3 x ULN at V1.","ALL","18 Years","90 Years",{"count":231,"type":232},50,"ESTIMATED","INTERVENTIONAL",[235],"PHASE4","Transthyretin (TTR) is a protein made by the liver that helps transport thyroid hormone and vitamin A in the blood. In some people, this protein breaks down and forms harmful clumps called amyloid. TTR amyloid gets deposited in the heart wall and stops it from pumping blood properly, which may lead to heart failure. The breakage in TTR protein can be age-related (wild-type ATTR-CM), or genetic (variant ATTR-CM).\n\nThe study drug, acoramidis, works by attaching itself to the TTR protein, making TTR more stable and less likely to break down and form amyloid (clumps). This helps to slow down the progression of the disease, improve heart function, and increase the TTR levels in the blood. Acoramidis is an approved treatment for wild-type or variant ATTR-CM in Europe and the United States.\n\nTafamidis is another drug that stabilizes TTR and prevents it from breaking down.\n\nIn this study, acoramidis will be studied in participants with ATTR--CM who were previously treated with tafamidis. The main purpose of this study is to assess the change in blood TTR levels after participants are switched from tafamidis to acoramidis. This will be studied to understand if acoramidis causes an increase in blood TTR levels beyond the levels achieved with tafamidis.\n\nFor this, the researchers will measure the change in the levels of TTR protein in participants' blood after 6 months of the treatment with acoramidis, or earlier if a participant stops the treatment before reaching that six-month mark.\n\nAll participants will continue taking tafamidis during the screening period. In the treatment period of the study, participants will take acoramidis as two tablets twice daily by mouth, for up to 6 months.\n\nAt the start of this study, the study doctors will review each participant's medical history and check their overall health. The study doctors will perform electrocardiograms (ECG), and measure blood pressure and heart rate. Researchers will also take blood and urine samples from the participants to measure levels of TTr, NT-proBNP, hs-TnT, hs-CRP, RBP4, eGFR, creatinine, cystatin-C, UACR, and TSH at the start of the study, and at various time points thereafter (during the study) to assess heart, kidney and thyroid function.\n\nThere will be a total of 9 study check-ins. Participants will visit the study site twice: at screening and at the end of treatment period. A study nurse will visit the participant's home 6 times, at the start of treatment, Weeks 1, 2, 3 and 4, then again at 3 months. The final check-in will be done by phone.\n\nThe study doctors will monitor the health of the participants regularly for any medical problems during follow-up visits. Participants will know the treatment they will receive during the study. Each participant could be in the study for about 8 months.",[238],"Transthyretin Amyloid Cardiomyopathy",[240],"ATTR-CM","2026-06-26",{"date":243,"type":244},"2026-06-29","ACTUAL",{"date":246,"type":244},"2026-02-13",{"date":248,"type":232},"2027-07-15",{"name":5,"class":6},20]