A Study to Evaluate the Effectiveness and Safety of Vutrisiran in Patients with Transthyretin Amyloidosis with Cardiomyopathy (ATTR Amyloidosis with Cardiomyopathy

Overview

About this study

The purpose of this study is to evaluate vutrisiran in patients with transthyretin amyloidosis with cardiomyopathy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria:

  • Age 18 (or age of legal consent per local regulations, whichever is older) to 85 years, inclusive.
  • 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Martha Grogan, M.D.

Open for enrollment

Contact information:

Amyloid Study Team

(507)266-4426

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

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