A Study to Learn About Tafamidis in Patients With Transthyretin Amyloid Cardiomyopathy (ATTR-CM) in India

Launched by PFIZER · Oct 11, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Tafamidis to see if it is safe for treating a heart condition known as Transthyretin Amyloid Cardiomyopathy (ATTR-CM) in India. ATTR-CM occurs when a protein called transthyretin, which is made in the liver, forms clumps in the heart, making it difficult for the heart to pump blood effectively. The study is looking for adult participants who have been diagnosed with this condition and are prescribed Tafamidis capsules to take by mouth.

If you decide to participate, you will take the Tafamidis capsules and the study team will monitor you for any side effects for up to six months. Side effects are any feelings or symptoms you think might be caused by the medication, and the study doctor will keep track of these. You won't necessarily need to visit the clinic regularly, as follow-up can happen over the phone. This study aims to gather important information about the safety of Tafamidis, which could help improve treatment options for people with ATTR-CM.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult patients (age ≥18 years) with diagnosis of cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM).
• • Patients to whom VyndaMx® Capsules is prescribed for the treatment of wild or hereditary ATTR-CM.
• Exclusion Criteria:
• • Patient with hypersensitivity to VyndaMx® Capsule or to any of the excipients in the product.
• • Patients with rare hereditary problems of fructose intolerance.
• • Patient who has a contraindication to VyndaMx® Capsules according to the approved local product label.