MAGNETICAL - MAGNetic resonance Evaluation of Tafamidis Impact in Cardiac AmyLoidosis
Key facts
- Where
- Guimaraes és Vila Real, PortugáliaSee the 2 sites
- Phase
- 4. fázis
Where in Portugália
- Unidade Local De Saude Do Alto Ave E.P.E.Guimaraes, PortugáliaNo longer taking part
- Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E.Vila Real, PortugáliaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E.
- Trial code
- EU 2024-518708-29-00
- Record updated
- 2024. november 6.
- Original description
To evaluate the evolution and correlation of cardiac magnetic resonance imaging parameters before and after treatment with tafamidis for 12 months.Read full original descriptionShow less
To evaluate the evolution and correlation of cardiac magnetic resonance imaging parameters before and after treatment with tafamidis for 12 months.
Inclusion: Diphosphonate scintigraphy with 99mTc-labelled radiotracers (grade 2 or 3 uptake) and cardiac involvement confirmed by means of echocardiography, with an end-diastolic interventricular septal wall thickness exceeding 12 mm and no evidence of a monoclonal protein by negative serum free light chain and negative serum and urine immunofixation OR Extracardiac biopsy positive for ATTR amyloidosis and cardiac involvement confirmed by means of echocardiography, with an enddiastolic interventricular septal wall thickness exceeding 12 mm OR Cardiac biopsy positive for ATTR amyloidosis; Medical history of heart failure - NYHA I-III; Age > 18 years and < 90 at screening; Capable of providing written informed consent, willing and able to adhere to protocol requirements; Patients with or without renal failure will also be included (for those with stage 4/5 CKD no late gadolinium enhancement will be performed); Able to comply with approved Summary of Product Characteristics recommendations for treatment with tafamidis 61mg.
Exclusion: Subjects using non-steroidal anti-inflammatory drugs (NSAIDS), tauroursodeoxycholate and doxycycline; Previous treatment with tafamidis or other alternatives in transthyretin amyloidosis; Heart failure due to other condition than CA in the opinion of the investigator; History of liver or cardiac transplant; Implanted cardiac device – pacemaker, defibrillator, cardiac resynchronization therapy; Liver transaminases > 2 upper normal limit; Subjects requiring treatment with calcium channel blockers or digitalis; Confirmed diagnosis of light-chain amyloidosis; Participating in another investigational study; Investigator determines that the subject is not suitable for study participation for any other reason; Subjects who are pregnant females; breastfeeding females; males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 28 days, after last dose of tafamidis; Familial amyloid polyneuropathy; NYHA IV; Severe malnutrition; Devices or other material non-MRI conditional.