Real-World Effectiveness of High-Dose Tafamidis on Neurologic Disease Progression in Mixed-Phenot… (NCT06393465) | Clinical Trial Compass
CompletedNot Applicable
Real-World Effectiveness of High-Dose Tafamidis on Neurologic Disease Progression in Mixed-Phenotype Transthyretin Amyloid Cardiomyopathy
United States50 participantsStarted 2024-06-15
Plain-language 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
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Rate of neurologic disease progression
Timeframe: Baseline through at least 12 months of treatment