A Prospective, Single-arm, Multicenter, Observational Safety Surveillance Study of VyndaMx® (Tafamidis Capsule 61 mg) in Patients With Transthyretin Amyloid Cardiomyopathy (ATTR-CM) in India

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
India
Sri Jayadeva Institute of Cardiovascular Sciences and Research
RECRUITING
Bangalore
AIG Hospital
RECRUITING
Hyderabad
Max Super Speciality Hospital
RECRUITING
New Delhi
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2024-03-25
Estimated Completion Date: 2025-07-31
Participants
Target number of participants: 15
Treatments
Patients with ATTR-CM in India
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov