NCT06393465Completed
Real-World Effectiveness of High-Dose Tafamidis on Neurologic Disease Progression in Mixed-Phenotype Transthyretin Amyloid Cardiomyopathy
Real-World Effectiveness of High-Dose Tafamidis on Neurologic Disease Progression in Mixed-Phenotype Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Source: ClinicalTrials.gov · Last updated 29 Apr 2026
Brief summary (registry, in English)
This study will examine the clinical effectiveness of Tafamidis in patients with Mixed Phenotype Transthyretin Amyloidosis using data that already exist in patients' medical records
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 50 (actual)
- First submitted
- 26 Apr 2024
- Start date
- 15 Jun 2024
- Primary completion date
- 7 Apr 2026
- Lead sponsor
- Pfizer
- Diseases
- Amyloidosis
- NCT number
- NCT06393465
What you commit to
- Study type: Observational
- Participants enrolled: 50
- From 15 Jun 2024 to the primary completion date, 7 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior or current treatment with any disease-modifying therapy (investigational or approved) alone or in combination, except tafamidis, as VYNDAQEL 80 mg \[four 20-mg tafamidis meglumine capsules\] orally once daily or VYNDAMAX 61 mg \[one 61-mg tafamidis capsule\] orally once daily.
Other illness
- History of any organ transplant.
- Peripheral neuropathy attributed to causes other than ATTR amyloidosis (eg, diabetes mellitus, B12 deficiency, hypothyroidism, shingles,Lyme disease, HIV infection, secondary to injury, chronic kidney disease).
Other
- Individuals who are non-ambulatory.
- Patient's data fails to pass data quality checks.
Who the study is looking for
- Age ≥18 years at diagnosis.
- Diagnosed with ATTRv-CM or ATTRwt-CM, mixed phenotype.
- Treated with tafamidis, as VYNDAMAX 61 mg (one 61-mg tafamidis capsule) orally once daily for ≥12 months or started on tafamidis 20 mg then switched to VYNDAMAX 61 mg for ≥12 months
- Have had ≥1 pre- and ≥1 post-treatment neurologic assessments.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pfizer Coordinator of this site? Confirm its status | New York | United States | Unknown status |
Related publications
- Neurologic Stability During Tafamidis Treatment in Transthyretin Amyloidosis with a Mixed Phenotype: A Multicenter Real-World Study.Cardiol Ther · 2026 · PMID 42844536
This page is information, not medical advice. Discuss any trial with your doctor.