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

ID studio #: NCT06260709

condizione: Transthyretin Amyloid Cardiomyopathy (ATTR CM)

stato: reclutamento

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).

intervento: NNC6019-0001

risultati: https://clinicaltrials.gov/ct2/show/results/NCT06260709

ultimo aggiornamento: 10 Marzo 2024

data d'inizio: 20 Febbraio 2024

completamento previsto: 29 Febbraio 2028

ultimo aggiornamento: 22 Febbraio 2024

fase di sviluppo: Fase 2

taglia / iscrizione: 80

risultati primari:

• Number of Treatment Emergent Adverse Events
  Measured as events.
• From baseline (week 0) up to visit 39 (week 156)
  

risultati secondari:

• Change in 6-Minute Walk Test (6MWT)
  From baseline (week 0) to visit 28 (week 104)
• Change in N-terminal-pro brain natriuretic peptide (NT-proBNP)
  From baseline (week 0) to visit 28 (week 104)
• Change in Myocardial Extracellular Volume (ECV)
  From baseline (week 0) to visit 28 (week 104)
• Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS)
  From baseline (week 0) to visit 28 (week 104)
• Change in Troponin I
  From baseline (week 0) to visit 28 (week 104)
• Change in Global Longitudinal Strain (GLS) on Echocardiography
  From baseline (week 0) to visit 28 (week 104)

criterio di inclusione:

criteri di esclusione: criteri:

A prior solid organ transplant.
Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, in-situ carcinomas of the cervix, or in-situ/high grade prostatic intraepithelial neoplasia (PIN) or low-grade prostate cancer) within 5 years before screening.
Current treatment with calcium channel blockers with conduction system effects (e.g., verapamil, diltiazem). The use of dihydropyridine calcium channel blockers is allowed. The use of digoxin will only be allowed if required for management of atrial fibrillation with rapid ventricular response.
Body weight greater than (>) 120 kilograms (kg) (264.6 pounds [lb]) at screening.

sponsor: Novo Nordisk A / S

contatti: Novo Nordisk, (+ 1) 866-867-7178, [email protected]

investigatori: Clinical Transparency (dept. 2834),Novo Nordisk A/S

sedi dei centri di prova: United States,Canada,Czechia,France,Germany,Italy,Netherlands,Portugal,Spain

• Stati Uniti, Arizona
  Mayo Clinic dell'Arizona
  
  
• Stati Uniti, California
  Cedars-Sinai Medical Center_Los Angeles
  
  
• Stati Uniti, California
  Stanford Hlth Cre-Boswell Clin
  
  
• Stati Uniti, Florida
  Clinica Mayo Jacksonville
  
  
• Stati Uniti, Illinois
  NW Univ-Bluhm Cardiovasc Inst
  
  
• Stati Uniti, Maryland
  Univ of MD Schl of Med
  
  
• Stati Uniti, Minnesota
  Mayo Clinica Rochester
  
  
• canadese, Alberta
  University of Calgary_Cardiology
  
  
• Canada, Columbia Britannica
  Ctr for Cardiovascular Innovation
  
  
• Repubblica Ceca
  II. Ambulatorio interno VFN – Cardiologia e angiologia
  
  
• Francia
  Ap-Hp-Ospedale Henri Mondor
  
  
• Francia
  Ospedale universitario di Tolosa-Ospedale Rangueil-1
  
  
• Germania
  Clinica e Policlinico LMU Klinikum di Monaco 1
  
  
• Germania
  Ospedale universitario di Münster, Dipartimento di Cardiologia I
  
  
• Germania
  Ospedale universitario Würzburg AöR
  
  
• Germania
  Universitätsklinik Heidelberg Innere Medizin III Kardiologie, Angiologie, Pneumologie
  
  
• Italy, PV
  Centro per lo Studio e la Cura delle Amiloidosi Sistemiche Fondazione IRCCS Policlinico San Matteo
  
  
• Italy, Pi
  Fondazione CNR-Regione Toscana Gabriele Monasterio
  
  
• Olanda
  UMC Groninga
  
  
• Olanda
  Centro medico universitario di Utrecht
  
  
• Portogallo
  Centro Hospitalar de Trás-os-Montes e Alto Douro
  
  
• Portogallo
  Hospital da Senhora da Oliveira – Guimarães
  
  
• Spagna, Madrid
  Ospedale universitario Iron Gate Majadahonda