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MAGNETICAL - MAGNetic resonance Evaluation of Tafamidis Impact in Cardiac AmyLoidosis
EU CTIS ID: 2024-518708-29-00
What this study is testing
To evaluate the evolution and correlation of cardiac magnetic resonance imaging parameters before and after treatment with tafamidis for 12 months.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Confirmed diagnosis of light-chain amyloidosis
- Liver transaminases > 2 upper normal limit
- Participating in another investigational study
- Subjects requiring treatment with calcium channel blockers or digitalis
- Subjects using non-steroidal anti-inflammatory drugs (NSAIDS), tauroursodeoxycholate and doxycycline
- Investigator determines that the subject is not suitable for study participation for any other reason
See the full eligibility criteria
- 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
- Confirmed diagnosis of light-chain amyloidosis
- Liver transaminases > 2 upper normal limit
- Participating in another investigational study
- Subjects requiring treatment with calcium channel blockers or digitalis
- Subjects using non-steroidal anti-inflammatory drugs (NSAIDS), tauroursodeoxycholate and doxycycline
- 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
- Heart failure due to other condition than CA in the opinion of the investigator
- History of liver or cardiac transplant
- Previous treatment with tafamidis or other alternatives in transthyretin amyloidosis
- Severe malnutrition
- Implanted cardiac device – pacemaker, defibrillator, cardiac resynchronization therapy
- Devices or other material non-MRI conditional
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.