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

NCT06086353 | Completed

• 2 other identifiers: B3461106NCT06086353
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Transthyretin Amyloid Cardiomyopathy

Keywords

Safety surveillance; Tafamidis

Outcome Measures

Primary Outcomes (1)

• Number of Adverse events with Tafamidis

  The safety of VyndaMx® Capsules is the primary objective of the study and will be assessed based on Adverse events which would occur within 6 months from first dosing. Investigator will collect the safety related data until 6 months from first dosing of Tafamidis Capsules and will record these data on the Case report Form.

  Baseline to 6 months

Study Arms (1)

Patients with ATTR-CM in India

Drug: Tafamidis

Interventions

Tafamidis DRUG

Patients on tafamidis will be observed

Patients with ATTR-CM in India

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients diagnosed with ATTR-CM and prescribed with VyndaMx® Capsule 61 mg according to routine clinical practice at 3 centers in India and willing to participate will be included in the study

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

Sri Jayadeva Institute of Cardiovascular Sciences and Research

Bangalore, Karnataka, 560069, India

Location

AIG Hospital

Hyderabad, 500032, India

Location

Max Super Speciality Hospital

New Delhi, 110017, India

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

tafamidis

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 17, 2023
• Study Start: March 25, 2024
• Primary Completion: June 6, 2025
• Study Completion: June 6, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (3)