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

jtauras@montefiore.org