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HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy

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.

Stanford is currently accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • drug: Vutrisiran
  • drug: Sterile Normal Saline (0.9% NaCl)

Eligibility


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

Ages Eligible for Study

18 Years - 85 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting