nctId: NCT06260709 id: NN6019-7565 id: 2022-502605-15-00 type: OTHER domain: European Medical Agency (EMA) 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 overallStatus: RECRUITING date: 2024-02-20 date: 2028-02-29 date: 2028-02-29 date: 2024-02-15 date: 2024-04-26 name: Novo Nordisk A/S class: INDUSTRY 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). conditions: Transthyretin Amyloid Cardiomyopathy (ATTR CM) studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: NNC6019-0001 measure: Number of Treatment Emergent Adverse Events measure: Change in 6-Minute Walk Test (6MWT) measure: Change in N-terminal-pro brain natriuretic peptide (NT-proBNP) measure: Change in Myocardial Extracellular Volume (ECV) measure: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) measure: Change in Troponin I measure: Change in Global Longitudinal Strain (GLS) on Echocardiography sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic Arizona status: NOT_YET_RECRUITING city: Phoenix state: Arizona zip: 85054 country: United States lat: 33.44838 lon: -112.07404 facility: Cedars-Sinai Medical Center_Los Angeles status: NOT_YET_RECRUITING city: Beverly Hills state: California zip: 90211 country: United States lat: 34.07362 lon: -118.40036 facility: Stanford Hlth Cre-Boswell Clin status: RECRUITING city: Stanford state: California zip: 94305 country: United States lat: 37.42411 lon: -122.16608 facility: Mayo Clinic Jacksonville status: NOT_YET_RECRUITING city: Jacksonville state: Florida zip: 32224 country: United States lat: 30.33218 lon: -81.65565 facility: NW Univ-Bluhm Cardiovasc Inst status: NOT_YET_RECRUITING city: Evanston state: Illinois zip: 60208 country: United States lat: 42.04114 lon: -87.69006 facility: Univ of MD Schl of Med status: RECRUITING city: Baltimore state: Maryland zip: 21201 country: United States lat: 39.29038 lon: -76.61219 facility: Mayo Clinic Rochester status: NOT_YET_RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States lat: 44.02163 lon: -92.4699 facility: University of Calgary_Cardiology status: NOT_YET_RECRUITING city: Calgary state: Alberta zip: T2N 4Z6 country: Canada lat: 51.05011 lon: -114.08529 facility: Ctr for Cardiovascular Innovation status: NOT_YET_RECRUITING city: Vancouver state: British Columbia zip: V5Z 1M9 country: Canada lat: 49.24966 lon: -123.11934 facility: II. interni klinika VFN - Kardiologie a angiologie status: NOT_YET_RECRUITING city: Praha 2 zip: 12808 country: Czechia lat: 50.08804 lon: 14.42076 facility: Ap-Hp-Hopital Henri Mondor status: NOT_YET_RECRUITING city: Créteil zip: 94000 country: France lat: 48.78333 lon: 2.46667 facility: Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1 status: NOT_YET_RECRUITING city: Toulouse Cedex 9 zip: 31059 country: France lat: 43.60426 lon: 1.44367 facility: Universitätsklinik Heidelberg Innere Medizin III Kardiologie, Angiologie, Pneumologie status: NOT_YET_RECRUITING city: Heidelberg zip: 69120 country: Germany lat: 49.40768 lon: 8.69079 facility: LMU Klinikum München Klinik und Poliklinik 1 status: NOT_YET_RECRUITING city: München zip: 81377 country: Germany lat: 48.13743 lon: 11.57549 facility: Uniklinik Münster, Klinik für Kardiologie I status: NOT_YET_RECRUITING city: Münster zip: 48149 country: Germany lat: 51.96236 lon: 7.62571 facility: Universitatsklinikum Wurzburg AöR status: NOT_YET_RECRUITING city: Würzburg zip: 97078 country: Germany lat: 49.79391 lon: 9.95121 facility: Fondazione CNR-Regione Toscana Gabriele Monasterio status: NOT_YET_RECRUITING city: Pisa state: Pi zip: 56124 country: Italy lat: 43.70853 lon: 10.4036 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 lat: 45.19205 lon: 9.15917 facility: UMC Groningen status: NOT_YET_RECRUITING city: Groningen zip: 9713 GZ country: Netherlands lat: 53.21917 lon: 6.56667 facility: Universitair Medisch Centrum Utrecht status: NOT_YET_RECRUITING city: Utrecht zip: 3584 CX country: Netherlands lat: 52.09083 lon: 5.12222 facility: Hospital da Senhora da Oliveira - Guimarães status: NOT_YET_RECRUITING city: Guimarães zip: 4835-044 country: Portugal lat: 41.44443 lon: -8.29619 facility: Centro Hospitalar de Trás-os-Montes e Alto Douro status: NOT_YET_RECRUITING city: Vila Real zip: 5000-508 country: Portugal lat: 41.30062 lon: -7.74413 facility: Hospital Universitario Puerta de Hierro Majadahonda status: NOT_YET_RECRUITING city: Majadahonda state: Madrid zip: 28222 country: Spain lat: 40.47353 lon: -3.87182 hasResults: False