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

Last updated: July 3, 2025
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

N/A

Condition

Amyloidosis

Circulation Disorders

Treatment

Tafamidis

Clinical Study ID

NCT06086353
B3461106
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to learn about the safety of Tafamidis for the treatment of Transthyretin amyloid cardiomyopathy (ATTR-CM) in India.

ATTR-CM is a condition that affects people's hearts. Transthyretin is a protein that is made in the liver. In some people this protein stops working and forms clumps called as amyloid. Transthyretin amyloid builds up in heart and stops the heart from pumping properly.

This study is seeking for participants who are:

  • confirmed with ATTR-CM.

  • given Tafamidis capsules to be taken by mouth.

The safety of Tafamidis capsules will be checked based on side effects. These side effects can happen within 6 months after taking Tafamidis. A side effect is something (expected or unexpected) that you feel was caused by a medicine or treatment you take. The study doctor will collect side effect information and put the information on patient's case form.

Follow-up of the patient's will be performed via clinic re-visit or over a call. It is not a rule for the participants to visit the clinic in this study.

This study will help to see if Tafamidis is safe.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients (age ≥18 years) with diagnosis of cardiomyopathy of wild type orhereditary transthyretin-mediated amyloidosis (ATTR-CM).

  • Patients to whom VyndaMx® Capsules is prescribed for the treatment of wild orhereditary ATTR-CM.

Exclusion

Exclusion Criteria:

  • Patient with hypersensitivity to VyndaMx® Capsule or to any of the excipients in theproduct.

  • Patients with rare hereditary problems of fructose intolerance.

  • Patient who has a contraindication to VyndaMx® Capsules according to the approvedlocal product label.

Study Design

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: Tafamidis
Phase:
Study Start date:
March 25, 2024
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • Sri Jayadeva Institute of Cardiovascular Sciences and Research

    Bangalore, Karnataka 560069
    India

    Active - Recruiting

  • AIG Hospital

    Hyderabad, 500032
    India

    Active - Recruiting

  • Max Super Speciality Hospital

    New Delhi, 110017
    India

    Active - Recruiting

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