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Real-World study checks tafamidis for rare heart disease in korea

NCT ID NCT06321523

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at how well the drug tafamidis 61mg works for Korean patients with a rare heart condition called transthyretin amyloid cardiomyopathy (ATTR-CM). Researchers tracked 13 patients who were already prescribed the drug in real-world clinics. They measured changes in heart function, symptoms, and lab tests over time to see if the medicine helped manage the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tafamidis 61mg
What this could lead to
If results are positive, this could confirm that tafamidis helps manage ATTR-CM in Korean patients, supporting its use in this population.
What could go wrong
This was a very small study (13 people) with no comparison group, so results may not apply broadly. It also only looked at people already taking the drug, which can bias findings.

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

13 people

The number who actually took part.

Started

Mar 2024

Finished

Oct 2025

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

Adults (more than 19 aged) who were prescribed Tafamidis 61mg after being diagnosed with ATTR-CM and have takne Tafamidis 61mg at least once. Participants will be enrolled through medical chart review from tertiary medical centers in Korea.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥19 years * Patients diagnosed with ATTR-CM (ATTRwt and ATTRv) with tissue biopsy or nuclear scintigraphy * Patients who was prescribed Tafamidis 61mg after being diagnosed with ATTR-CM and have taken Tafamidis 61mg at least once. Exclusion Criteria: * Presence of other amyloidosis

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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

  • Gangnam Severance Hospital

    Seoul, 06273, South Korea

  • Pusan National University Hospital

    Busan, 49241, South Korea

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [seoul], 06351, South Korea

  • Severance Hopital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [seoul], 03722, South Korea

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