HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
Trial ID or NCT#
NCT04153149
Status
RECRUITING
Purpose
This study will evaluate the efficacy and safety of vutrisiran 25 mg administered subcutaneously (SC) once every 3 months (q3M) compared to placebo in patients with ATTR amyloidosis with cardiomyopathy.
Official Title
HELIOS-B: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy (ATTR Amyloidosis With Cardiomyopathy)
Eligibility Criteria
Ages Eligible for Study: 18 Years to 85 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- - Has a documented diagnosis of transthyretin (ATTR) amyloidosis with cardiomyopathy, classified as either hereditary ATTR (hATTR) amyloidosis with cardiomyopathy or wild-type ATTR (wtATTR) amyloidosis with cardiomyopathy meeting pre-specified diagnostic criteria - Has medical history of heart failure (HF) with at least 1 prior hospitalization for HF OR clinical evidence of HF
Exclusion Criteria:
- - Has known primary amyloidosis or leptomeningeal amyloidosis - Has New York Heart Association (NYHA) Class IV heart failure - Has NYHA Class III heart failure AND is at high risk based on pre-specified criteria - Has a polyneuropathy disability (PND) Score IIIa, IIIb, or IV at the Screening visit - Has estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2 - Has received prior TTR-lowering treatment - Has other non-TTR cardiomyopathy, hypertensive cardiomyopathy, cardiomyopathy due to valvular heart disease, or cardiomyopathy due to ischemic heart disease
Investigator(s)
Kevin M. Alexander, MD, FACC, FHFSA
Heart failure cardiologist
Assistant Professor of Medicine (Cardiovascular Medicine)
View on ClinicalTrials.gov
