Myocardial Effects in Patients with ATTRv with Polyneuropathy Treated with Patisiran or Vutrisiran

Launched by RENNES UNIVERSITY HOSPITAL · May 15, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating how two treatments, Patisiran and Vutrisiran, affect the heart in patients with a condition called hereditary transthyretin amyloidosis (ATTRv). This disease can cause both nerve damage and heart problems, and while these treatments have shown promise in helping with nerve issues, we want to learn more about their effects on the heart, especially in patients who also have stage 1 or 2 polyneuropathy, which refers to nerve damage. The goal is to better understand how these treatments impact heart function and structure in individuals with this condition.

To participate in this study, candidates must be 18 years or older, have been diagnosed with ATTRv and have not received prior treatment for it. Participants should also have mild to moderate heart disease (classified as NYHA stage 1 or 2). The trial is currently recruiting participants, and those who join can expect to be monitored for their heart health over a period while receiving either of the treatments. It's important for potential participants to know that those with certain conditions, like being treated with a different medication called Tafamidis or having specific health issues that prevent certain tests, will not be eligible for this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients aged 18 years or older
• • Patients with hereditary transthyretin amyloidosis (ATTRv) with stage 1 or 2 polyneuropathy
• • Patient not previously treated for ATTRv
• • Patients for whom treatment with patisiran or vutrisiran has been initiated by a hospital neurologist in accordance with recommendations for a minimum of 24 months.
• • Patients with NYHA stage 1 and 2 cardiac disease.
• • Beneficiary of a social security scheme
• • Person who does not object to his/her participation in the research
• Exclusion Criteria:
• • Patients treated with Tafamidis simultaneously with patisiran or vutrisiran
• • Adults under legal protection (legal guardianship, curatorship, guardianship), persons deprived of liberty.
• • Contraindications to the explorations provided for in the protocol: claustrophobia, metallic implant contraindicating MRI, woman of childbearing age