NCT06086353Completed
A Study to Learn About Tafamidis in Patients With Transthyretin Amyloid Cardiomyopathy (ATTR-CM) in India
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
Source: ClinicalTrials.gov · Last updated 20 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 6 (actual)
- First submitted
- 11 Oct 2023
- Start date
- 25 Mar 2024
- Primary completion date
- 6 Jun 2025
- Lead sponsor
- Pfizer
- Diseases
- Amyloidosis
- NCT number
- NCT06086353
What you commit to
- Study type: Observational
- Participants enrolled: 6
- From 25 Mar 2024 to the primary completion date, 6 Jun 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patient with hypersensitivity to VyndaMx® Capsule or to any of the excipients in the product.
Other
- Patients with rare hereditary problems of fructose intolerance.
- Patient who has a contraindication to VyndaMx® Capsules according to the approved local product label.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sri Jayadeva Institute of Cardiovascular Sciences and Research Coordinator of this site? Confirm its status | Bangalore | India | Unknown status |
| Aig Hospital Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| Max Super Speciality Hospital Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.