Transthyretin Amyloid CardiomyopathyNCT06321523
A Study to Learn About the Study Medicine Called Tafamidis 61mg in People Diagnosed With Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
An observational study of Transthyretin Amyloid Cardiomyopathy, run by Pfizer at 4 sites in South Korea.
Trial summary
The purpose of this clinical trial is to learn about the effects of the study medicine (called Tafamidis 61milligrams (mg)) for the potential treatment of Transthyretin amyloid cardiomyopathy (ATTR-CM). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Transthyretin Amyloid Cardiomyopathy
- What is being tested?
- Tafamidis 61 milligrams
- How many people
- 13 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 19 Mar 2024to 13 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Presence of other amyloidosis
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Pusan National University Hospital
Busan, 49241
Severance Hopital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], 03722
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul], 06351
Gangnam Severance Hospital
Seoul, 06273
About this study
Official title: Clinical Benefit of Tafamidis 61mg for Transthyretin Amyloid Cardiomyopathy (ATTR-CM) Patients in Korean Population in the Real-world Setting, Multicenter, Non-interventional Study
The purpose of this clinical trial is to learn about the effects of the study medicine (called Tafamidis 61milligrams (mg)) for the potential treatment of Transthyretin amyloid cardiomyopathy (ATTR-CM).
This study is seeking participants who were prescribed Tafamidis 61mg after being diagnosed with ATTR-CM and have taken Tafamidis 61mg at least once.
We will examine the experiences of people receiving the study medicine. This will help us determine if the study medicine is safe and effective.
- Conditions
- Transthyretin Amyloid Cardiomyopathy
- Being tested
- Tafamidis 61 milligrams
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tafamidis 61 milligramsDrug
Tafamidis 61mg as provided in real-world practice
| Study group | Role | What they receive |
|---|---|---|
| ATTR-CM patients in Korea | transthyretin amyloid cardiomyopathy (ATTR-CM) patients in Korea Receives: Drug: Tafamidis 61 milligrams |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification
Measured: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Change from baseline in six-minute walk test
Measured: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS)
Measured: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration
Measured: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Change From Baseline in Troponin I and Troponin T
Measured: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
number of participants with Any Heart Block
Measured: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
number of participants with Atrioventricular (AV) block
Measured: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Change From Baseline in Left Ventricular Ejection Fraction
Measured: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Change From a Baseline in Diastolic function grades
Measured: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Change from Baseline in Left Ventricular Wall Thickness
Measured: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Change From Baseline in Global Longitudinal Strain scores
Measured: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Secondary outcomes (2)
Frequency of cardiovascular hospitalizations
Measured: Up to 24 months
Frequency of death due to any cause
This includes participants who discontinue for transplantation (heart transplantation and combined heart and liver transplantation) or for implantation of a cardiac mechanical assist device.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start19 Mar 2024
- Primary completion13 Oct 2025
- Study completion13 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transthyretin Amyloid CardiomyopathyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321523
- Sponsor's protocol ID
- B3461122
- Other IDs
- NCT06321523
- Status last verified
- Nov 2025
- First submitted
- 13 Mar 2024
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Benefit of Tafamidis 61mg for Transthyretin Amyloid Cardiomyopathy (ATTR-CM) Patients in Korean Population in the Real-world Setting, Multicenter, Non-interventional Study
- ClinicalTrials.gov ID
- NCT06321523
- Acronym / sponsor ID
- B3461122
- Conditions
- Transthyretin Amyloid Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 13 Oct 2025 (actual)
- Study completion
- 13 Oct 2025 (actual)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to learn about the effects of the study medicine (called Tafamidis 61milligrams (mg)) for the potential treatment of Transthyretin amyloid cardiomyopathy (ATTR-CM).
This study is seeking participants who were prescribed Tafamidis 61mg after being diagnosed with ATTR-CM and have taken Tafamidis 61mg at least once.
We will examine the experiences of people receiving the study medicine. This will help us determine if the study medicine is safe and effective.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATTR-CM patients in Korea | – | Drug: Tafamidis 61 milligramstransthyretin amyloid cardiomyopathy (ATTR-CM) patients in Korea |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Presence of other amyloidosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tafamidis 61 milligramsTafamidis 61mg as provided in real-world practice | Drug | ATTR-CM patients in Korea |
Primary outcome
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification
Time frame: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Change from baseline in six-minute walk test
Time frame: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS)
Time frame: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration
Time frame: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Change From Baseline in Troponin I and Troponin T
Time frame: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
number of participants with Any Heart Block
Time frame: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
number of participants with Atrioventricular (AV) block
Time frame: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Change From Baseline in Left Ventricular Ejection Fraction
Time frame: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Change From a Baseline in Diastolic function grades
Time frame: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Change from Baseline in Left Ventricular Wall Thickness
Time frame: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
Change From Baseline in Global Longitudinal Strain scores
Time frame: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg
2 secondary outcomes
Frequency of cardiovascular hospitalizations
Time frame: Up to 24 months
Frequency of death due to any cause
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Related trials for Transthyretin Amyloid Cardiomyopathy
Not yet recruitingObservational study
Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor
Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Not yet recruitingPhase 2
Effect of Trimetazidine on Coronary Flow in Transthyretin Cardiac Amyloidosis
Transthyretin Cardiac Amyloidosis
Not yet recruitingObservational study
PET Imaging Study Using Evuzamitide to Detect Cardiac Amyloidosis in Patients With Inconclusive Nuclear Scans and Elevated TAD1 Levels
Amyloidogenic Transthyretin (ATTR) Amyloidosis, Cardiac Amyloidosis
Active, not recruitingPhase 3
Study of ALXN2220 Versus Placebo in Adults With ATTR-CM
Transthyretin Amyloid Cardiomyopathy
Enrolling by invitationPhase 3
A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy
Transthyretin Amyloidosis (ATTR) With Cardiomyopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transthyretin Amyloid Cardiomyopathy, run by Pfizer at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Change From Baseline in New York Heart Association (NYHA) Classification (time frame: baseline and 6, 12, 18, and 24 months after taking Tafamidis 61mg). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.