10-Year study tracks heart drug vyndamax in Real-World patients
NCT ID NCT04801329
First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 3 times
Summary
This study is monitoring 110 adults in Korea who are taking Vyndamax (tafamidis) for a rare heart condition called ATTR-CM. The goal is to track side effects and see how well the drug works over 10 years in everyday medical practice. Researchers will check heart function and symptom changes at 6 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Vyndamax (tafamidis) capsules
- What this could lead to
- If successful, this study could confirm that Vyndamax is safe and effective for treating ATTR-CM in real-world Korean patients, supporting its continued use.
- What could go wrong
- This is an observational study, not a controlled trial, so results may be less definitive. It monitors existing treatment, not testing a new approach, so no major breakthroughs are expected.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
110 people
The number who actually took part.
- Started
-
Jun 2021
- Finished
-
Apr 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study will be performed in patients who have received at least 1 dose of Vyndamax Capsules for the following indications as per local product label.(Treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization)
- Ages
-
19 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
\*Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: * 1\. Adult patients with the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) * 2\. Patients to whom Vyndamax® Capsules is prescribed for the treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) * 3\. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. * Exclusion criteria Patients meeting any of the following criteria will not be included in the study according to the local product label: * 1\. Patient with hypersensitivity or case history to tafamidis or to any of the excipients in the product * 2\. This product contains sorbitol (E420). Patients with rare hereditary problems of fructose intolerance should not take this medicine. * 3\. Patient who has a contraindication to Vyndamax® Capsules according to the approved local product label
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Pfizer
Seoul, South Korea
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Other studies related to the condition(s) this trial covers.