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Real-World Effectiveness of High-Dose Tafamidis on Neurologic Disease Progression in Mixed-Phenotype Transthyretin Amyloid Cardiomyopathy | Clinical Trials | Clareo Health

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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)

NCT06393465•Pfizer

View on ClinicalTrials.gov

Summary

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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)

Pfizer

New York, New York, United States

Key Dates

Start Date

June 15, 2024

Primary Completion Date

February 20, 2026

Completion Date

February 20, 2026

Last Updated

February 11, 2026

Enrollment

ACTUAL participants

Conditions

Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)

Interventions

Tafamidis

DRUG