2024-518708-29-00
Not yet recruiting
Phase 4
MAGNETICAL - MAGNetic resonance Evaluation of Tafamidis Impact in Cardiac AmyLoidosis
Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E.2 sites in 1 country30 target enrollmentStarted: November 6, 2024Last updated:
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E.
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Change from baseline at each point in CMR imaging parameters, including: ventricular volumes, mass, ejection fraction; native T1 and T2 mapping; ECV; LookLocker at 2, 5 and 10 minutes; LGE, Strain analysis and 4D flow
Overview
Brief Summary
To evaluate the evolution and correlation of cardiac magnetic resonance imaging parameters before and after treatment with tafamidis for 12 months.
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion 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
Exclusion Criteria
- •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
- •Heart failure due to other condition than CA in the opinion of the investigator
- •History of liver or cardiac transplant
Outcomes
Primary Outcomes
Change from baseline at each point in CMR imaging parameters, including: ventricular volumes, mass, ejection fraction; native T1 and T2 mapping; ECV; LookLocker at 2, 5 and 10 minutes; LGE, Strain analysis and 4D flow
Change from baseline at each point in CMR imaging parameters, including: ventricular volumes, mass, ejection fraction; native T1 and T2 mapping; ECV; LookLocker at 2, 5 and 10 minutes; LGE, Strain analysis and 4D flow
Secondary Outcomes
- Frequency of heart failure related hospitalization and all-cause mortality
- Change from baseline at each point in the Kansas City Cardiomyopathy
- Questionnaire overall score
- Change from baseline at each point in 6MWT distance
- Change from baseline at each point in NT-proBNP concentration
- Change from baseline at each point in NYHA classification
- Change from baseline at each point in echocardiographic parameters
Investigators
COORDINATING INVESTIGATOR
Scientific
Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E.
Study Sites (2)
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