Estudio de ensayos clínicos
Fase 3
TRITON-CM: A Study to Evaluate Nucresiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
Conditions: Transthyretin Amyloidosis With Cardiomyopathy
- Estudiar #:
- NCT07052903
- Última actualización:
- 05/14/2026
- Estado de la contratación:
- Reclutamiento
- Fecha estimada de finalización del estudio:
- 11/30/2032
Resumen
The purpose of this study is to: * Evaluate the efficacy of nucresiran compared to placebo on reducing all-cause mortality and cardiovascular (CV) events * Evaluate the efficacy of nucresiran compared to placebo on additional assessments of CV events and/or death * Evaluate the efficacy of nucresiran compared to placebo on patient-reported health status and health-related quality of life
Age: 18 Years to 85 Years old
Género: Todos
Fecha de inicio: 07/02/2025
Fecha de finalización principal (estimada): 05/28/2030
Fecha estimada de finalización del estudio: 11/30/2032
Acepta voluntarios sanos: No
Propósito y descripción del ensayo
Criterios de elegibilidad
Age: 18 Years to 85 Years old
Género: Todos
Acepta voluntarios sanos: No
Criterios de inclusión
* Has documented diagnosis of ATTR amyloidosis with cardiomyopathy including those with hereditary ATTR (hATTR) or wild-type ATTR (wATTR) amyloidosis.
* Has medical history of heart failure (HF) with at least 1 prior hospitalization for HF or signs and symptoms that require treatment with a diuretic.
* Has screening N-terminal prohormone B-type natriuretic peptide (NT-proBNP) \>300 ng/L and \<8500 ng/L; In patients with permanent or persistent atrial fibrillation, screening NT-proBNP \>600 ng/L and \<8500 ng/L.
* Patients may be receiving approved TTR stabilizers for ATTR amyloidosis (eg, tafamidis, acoramidis) and may be receiving background therapy for HF at the discretion of the Investigator.
Criterios de exclusión
* Has New York Heart Association (NYHA) Class IV HF; or NYHA Class III heart failure AND ATTR Amyloidosis Disease Stage 3.
* Has a polyneuropathy disability (PND) Score IIIa, IIIb, or IV.
* Has an estimated glomerular filtration rate eGFR of \<30 mL/min/1.73m\^2 at screening.
* Has received prior or currently receiving TTR-lowering therapy
Investigador principal
James Tauras, MD
Para obtener más información sobre este estudio, póngase en contacto con:
James Tauras