Transthyretin Amyloid CardiomyopathyNCT06086353
A Study to Learn About Tafamidis in Patients With Transthyretin Amyloid Cardiomyopathy (ATTR-CM) in India
An observational study of Transthyretin Amyloid Cardiomyopathy, run by Pfizer at 3 sites in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transthyretin Amyloid Cardiomyopathy
- What is being tested?
- Tafamidis
- How many people
- 6 participants
- Where
- 3 sitesIndia
- Study dates
- 25 Mar 2024to 6 Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients diagnosed with ATTR-CM and prescribed with VyndaMx® Capsule 61 mg according to routine clinical practice at 3 centers in India and willing to participate will be included in the study
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
India3 sites
Sri Jayadeva Institute of Cardiovascular Sciences and Research
Bangalore, Karnataka, 560069
AIG Hospital
Hyderabad, 500032
Max Super Speciality Hospital
New Delhi, 110017
About this study
Official title: 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
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.
Read more
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.
- Conditions
- Transthyretin Amyloid Cardiomyopathy
- Being tested
- Tafamidis
- Keywords
- Safety surveillance, Tafamidis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TafamidisDrug
Patients on tafamidis will be observed
| Study group | Role | What they receive |
|---|---|---|
| Patients with ATTR-CM in India | Not described Receives: Drug: Tafamidis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse events with Tafamidis
The safety of VyndaMx® Capsules is the primary objective of the study and will be assessed based on Adverse events which would occur within 6 months from first dosing. Investigator will collect the safety related data until 6 months from first dosing of Tafamidis Capsules and will record these data on the Case report Form.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start25 Mar 2024
- Primary completion6 Jun 2025
- Study completion6 Jun 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 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
- NCT06086353
- Sponsor's protocol ID
- B3461106
- Other IDs
- NCT06086353
- Status last verified
- Nov 2025
- First submitted
- 11 Oct 2023
- 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
- 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
- ClinicalTrials.gov ID
- NCT06086353
- Acronym / sponsor ID
- B3461106
- Conditions
- Transthyretin Amyloid Cardiomyopathy
- Keywords
- Safety surveillance, Tafamidis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 6 Jun 2025 (actual)
- Study completion
- 6 Jun 2025 (actual)
- First posted
- 17 Oct 2023 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with ATTR-CM in India | – | Drug: Tafamidis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients diagnosed with ATTR-CM and prescribed with VyndaMx® Capsule 61 mg according to routine clinical practice at 3 centers in India and willing to participate will be included in the study
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| TafamidisPatients on tafamidis will be observed | Drug | Patients with ATTR-CM in India |
Primary outcome
Number of Adverse events with Tafamidis
Time frame: Baseline to 6 months
The safety of VyndaMx® Capsules is the primary objective of the study and will be assessed based on Adverse events which would occur within 6 months from first dosing. Investigator will collect the safety related data until 6 months from first dosing of Tafamidis Capsules and will record these data on the Case report Form.
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.
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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
3 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 3 sites in India.
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 2 inclusion and 3 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 3 sites in India. 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 Adverse events with Tafamidis (time frame: Baseline to 6 months). 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.