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Real-World Effectiveness of High-Dose Tafamidis on Neurologic Disease Progression in Mixed-Phenotype Transthyretin Amyloid Cardiomyopathy

NCT06393465

CompletedN/A

Sponsor: Pfizer

Conditions: Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)

Interventions: Tafamidis

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* History of any organ transplant.
* Individuals who are non-ambulatory.
* 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.
* 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).
* Patient's data fails to pass data quality checks.

Locations (1)

New York, New York, United States