Learning about Tafamidis for heart disease 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
This study is testing how safe Tafamidis is for adults with a specific heart disease called Transthyretin Amyloid Cardiomyopathy in India.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 2 sites (Bangalore, Karnataka and 1 other locations) |
| Trial ID | NCT06086353 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety of Tafamidis in patients diagnosed with Transthyretin Amyloid Cardiomyopathy (ATTR-CM) in India. Participants will be adults who have been prescribed Tafamidis capsules, and the study will monitor any side effects experienced over a six-month period. Follow-up will occur through clinic visits or phone calls to collect data on the safety and tolerability of the treatment. The study focuses on understanding how Tafamidis affects patients with this specific heart condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with wild type or hereditary transthyretin-mediated amyloidosis.
Not a fit: Patients with hypersensitivity to Tafamidis or contraindications as per the local product label may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety profile of Tafamidis, potentially improving treatment options for patients with ATTR-CM.
How similar studies have performed: While there have been studies on Tafamidis, this specific observational approach in India is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bangalore, Karnataka and 1 other locations
- Sri Jayadeva Institute of Cardiovascular Sciences and Research — Bangalore, Karnataka, India (Recruiting)
- AIG Hospital — Hyderabad, India (Recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.