protocolSection identificationModule nctId: NCT06260709, orgStudyIdInfo id: NN6019-7565, secondaryIdInfos id: 2022-502605-15-00, type: OTHER, domain: European Medical Agency (EMA), secondaryIdInfos id: U1111-1284-5820, type: OTHER, domain: World Health Organization (WHO), briefTitle: A Research Study to Look at Long-term Treatment With a Medicine Called NNC6019-0001 for People Who Have Heart Failure Due to Transthyretin Amyloidosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2028-02-29, completionDateStruct date: 2028-02-29, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Novo Nordisk A/S, class: INDUSTRY, descriptionModule briefSummary: This study will test a medicine, NNC6019-0001, for people who have a heart disease due to TTR amyloidosis. It will look at how safe this medicine is in the long term and if it can reduce symptoms of a heart disease due to TTR amyloidosis, such as heart failure. It is an extension to a study called "A research study to look at how a new medicine called NNC6019-0001 works and how safe it is for people who have a heart disease due to TTR amyloidosis". Only participants who have completed that study will be invited for this new study. Participants will get NNC6019-0001, regardless of whether they got placebo or NNC6019-0001 in the first study. The study will last for up to 157 weeks (36 months/3 years)., conditionsModule conditions: Transthyretin Amyloid Cardiomyopathy (ATTR CM), designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: NNC6019-0001, outcomesModule primaryOutcomes measure: Number of Treatment Emergent Adverse Events, secondaryOutcomes measure: Change in 6-Minute Walk Test (6MWT), secondaryOutcomes measure: Change in N-terminal-pro brain natriuretic peptide (NT-proBNP), secondaryOutcomes measure: Change in Myocardial Extracellular Volume (ECV), secondaryOutcomes measure: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS), secondaryOutcomes measure: Change in Troponin I, secondaryOutcomes measure: Change in Global Longitudinal Strain (GLS) on Echocardiography, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic Arizona, status: NOT_YET_RECRUITING, city: Phoenix, state: Arizona, zip: 85054, country: United States, geoPoint lat: 33.44838, lon: -112.07404, locations facility: Cedars-Sinai Medical Center_Los Angeles, status: NOT_YET_RECRUITING, city: Beverly Hills, state: California, zip: 90211, country: United States, geoPoint lat: 34.07362, lon: -118.40036, locations facility: Stanford Hlth Cre-Boswell Clin, status: RECRUITING, city: Stanford, state: California, zip: 94305, country: United States, geoPoint lat: 37.42411, lon: -122.16608, locations facility: Mayo Clinic Jacksonville, status: NOT_YET_RECRUITING, city: Jacksonville, state: Florida, zip: 32224, country: United States, geoPoint lat: 30.33218, lon: -81.65565, locations facility: NW Univ-Bluhm Cardiovasc Inst, status: NOT_YET_RECRUITING, city: Evanston, state: Illinois, zip: 60208, country: United States, geoPoint lat: 42.04114, lon: -87.69006, locations facility: Univ of MD Schl of Med, status: RECRUITING, city: Baltimore, state: Maryland, zip: 21201, country: United States, geoPoint lat: 39.29038, lon: -76.61219, locations facility: Mayo Clinic Rochester, status: NOT_YET_RECRUITING, city: Rochester, state: Minnesota, zip: 55905, country: United States, geoPoint lat: 44.02163, lon: -92.4699, locations facility: University of Calgary_Cardiology, status: NOT_YET_RECRUITING, city: Calgary, state: Alberta, zip: T2N 4Z6, country: Canada, geoPoint lat: 51.05011, lon: -114.08529, locations facility: Ctr for Cardiovascular Innovation, status: NOT_YET_RECRUITING, city: Vancouver, state: British Columbia, zip: V5Z 1M9, country: Canada, geoPoint lat: 49.24966, lon: -123.11934, locations facility: II. interni klinika VFN - Kardiologie a angiologie, status: NOT_YET_RECRUITING, city: Praha 2, zip: 12808, country: Czechia, geoPoint lat: 50.08804, lon: 14.42076, locations facility: Ap-Hp-Hopital Henri Mondor, status: NOT_YET_RECRUITING, city: Créteil, zip: 94000, country: France, geoPoint lat: 48.78333, lon: 2.46667, locations facility: Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1, status: NOT_YET_RECRUITING, city: Toulouse Cedex 9, zip: 31059, country: France, geoPoint lat: 43.60426, lon: 1.44367, locations facility: Universitätsklinik Heidelberg Innere Medizin III Kardiologie, Angiologie, Pneumologie, status: NOT_YET_RECRUITING, city: Heidelberg, zip: 69120, country: Germany, geoPoint lat: 49.40768, lon: 8.69079, locations facility: LMU Klinikum München Klinik und Poliklinik 1, status: NOT_YET_RECRUITING, city: München, zip: 81377, country: Germany, geoPoint lat: 48.13743, lon: 11.57549, locations facility: Uniklinik Münster, Klinik für Kardiologie I, status: NOT_YET_RECRUITING, city: Münster, zip: 48149, country: Germany, geoPoint lat: 51.96236, lon: 7.62571, locations facility: Universitatsklinikum Wurzburg AöR, status: NOT_YET_RECRUITING, city: Würzburg, zip: 97078, country: Germany, geoPoint lat: 49.79391, lon: 9.95121, locations facility: Fondazione CNR-Regione Toscana Gabriele Monasterio, status: NOT_YET_RECRUITING, city: Pisa, state: Pi, zip: 56124, country: Italy, geoPoint lat: 43.70853, lon: 10.4036, locations facility: Centro per lo Studio e la Cura delle Amiloidosi Sistemiche Fondazione IRCCS Policlinico San Matteo, status: NOT_YET_RECRUITING, city: Pavia, state: PV, zip: 27100, country: Italy, geoPoint lat: 45.19205, lon: 9.15917, locations facility: UMC Groningen, status: NOT_YET_RECRUITING, city: Groningen, zip: 9713 GZ, country: Netherlands, geoPoint lat: 53.21917, lon: 6.56667, locations facility: Universitair Medisch Centrum Utrecht, status: NOT_YET_RECRUITING, city: Utrecht, zip: 3584 CX, country: Netherlands, geoPoint lat: 52.09083, lon: 5.12222, locations facility: Hospital da Senhora da Oliveira - Guimarães, status: NOT_YET_RECRUITING, city: Guimarães, zip: 4835-044, country: Portugal, geoPoint lat: 41.44443, lon: -8.29619, locations facility: Centro Hospitalar de Trás-os-Montes e Alto Douro, status: NOT_YET_RECRUITING, city: Vila Real, zip: 5000-508, country: Portugal, geoPoint lat: 41.30062, lon: -7.74413, locations facility: Hospital Universitario Puerta de Hierro Majadahonda, status: NOT_YET_RECRUITING, city: Majadahonda, state: Madrid, zip: 28222, country: Spain, geoPoint lat: 40.47353, lon: -3.87182, hasResults: False