Recruiting

Vutrisiran

Sponsor:

Alnylam Pharmaceuticals

Code:

NCT07358078

Conditions

Transthyretin Amyloidosis With Cardiomyopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The purpose of this study is to:

  • Describe the clinical characteristics of adult patients with transthyretin-mediated amyloidosis with cardiomyopathy (ATTR-CM) treated with vutrisiran in routine clinical care
  • Describe treatment patterns of adult patients with ATTR-CM treated with vutrisiran in routine clinical care
  • Assess health-related quality of life (HRQOL) in adult patients with ATTR-CM treated with vutrisiran in routine clinical care
  • Assess healthcare resource use (HCRU) in adult patients with ATTR-CM treated with vutrisiran in routine clinical care
  • Compare the long-term effectiveness of vutrisiran versus other approved ATTR-CM treatments in routine clinical care

Conditions

Transthyretin Amyloidosis With Cardiomyopathy

Study ID

NCT07358078

Start date

Jan 9, 2026

Status verified date

Sep, 2026

Completion date

Oct 23, 2030

Anticipated

Primary completion date

Oct 23, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Has a diagnosis of ATTR-CM
  • Is initiating treatment with vutrisiran or another approved ATTR-CM therapy

Exclusion Criteria:

  • Is enrolled in an interventional clinical trial

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with ATTR-CM

Patients with ATTR-CM.

Primary outcome measure

  • New York Heart Association (NYHA) Class [ Time Frame: From time of ATTR-CM diagnosis up to 5 years ]
  • Outpatient Diuretic Intensification [ Time Frame: From time of enrollment for up to 5 years ]
  • Norfolk Quality of Life - Diabetic Neuropathy (QOL-DN) Total Score [ Time Frame: From time of enrollment (if available) or ATTR-CM diagnosis up to 5 years ]
  • Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: From time of enrollment (if available) or ATTR-CM diagnosis up to 5 years ]
  • Patient Global Impressions - Change (PGI-C) [ Time Frame: From time of enrollment (if available) or ATTR-CM diagnosis up to 5 years ]
  • Patient Global Impressions - Severity (PGI-S); [ Time Frame: From time of enrollment (if available) or ATTR-CM diagnosis up to 5 years ]
  • Treatment Satisfaction Questionnaire for Medication version 9 (TSQM-9) [ Time Frame: From time of enrollment (if available) or ATTR-CM diagnosis up to 5 years ]

Central Contacts and Locations

Central contacts

Clinical Trial Information Line

1-877-ALNYLAMclinicaltrials@alnylam.com

Clinical Trial Information Line

1-877-256-9526clinicaltrials@alnylam.com

Locations

Clinical Trial Site

Recruiting

Tucson, Arizona, United States, 85711

Clinical Trial Site

Recruiting

Beverly Hills, California, United States, 90211

Clinical Trial Site

Recruiting

Naples, Florida, United States, 34102

Clinical Trial Site

Recruiting

Kansas City, Kansas, United States, 66160

Clinical Trial Site

Recruiting

Boston, Massachusetts, United States, 02215

Clinical Trial Site

Recruiting

St Louis, Missouri, United States, 63110

Clinical Trial Site

Recruiting

New Brunswick, New Jersey, United States, 08901

Clinical Trial Site

Recruiting

Charlotte, North Carolina, United States, 28270

Clinical Trial Site

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Clinical Trial Site

Recruiting

Memphis, Tennessee, United States, 38120

Clinical Trial Site

Recruiting

Dallas, Texas, United States, 75390

More Information

Sponsor

Alnylam Pharmaceuticals

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

  • ATTR-CM
  • Transthyretin
  • Amyloidosis
  • ATTR
  • Cardiomyopathy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Alnylam Pharmaceuticals on 2026-09-09.