SODIUM FLUORIDE (18F) for Transthyretin amyloid cardiomyopathy | AL amyloidosis | Hypertrophic cardiomyopathy

Inclusion criteria

• {"criterion_text":"- Completion of informed consent"}
• {"criterion_text":"- Age > 40 years for patients with ATTR or AL cardiac amyloidosis and age >30 years for patients with HCM"}
• {"criterion_text":"- ATTR cardiac amyloid according to Expert Consensus Recommendations OR AL amyloidosis according to Expert Consensus Recommendations OR Hypertrophic cardiomyopathy according to European Society of Cardiology guidelines"}

Exclusion criteria

• {"criterion_text":"- Inability or unwilling to give informed consent"}
• {"criterion_text":"- Only for MIBG-scan: Parkinson’s disease as mentioned in patients’ medical history"}
• {"criterion_text":"- Only for MIBG-scan: Insulin dependent diabetes mellitus as shown in patients’ actual medication list"}
• {"criterion_text":"- Women who are pregnant, breastfeeding or of child-bearing potential (women who have experienced menarche, are pre-menopausal and have not been sterilised) will not be enrolled into the trial"}
• {"criterion_text":"- Renal dysfunction (eGFR ≤30 mL/min/1.73m2)"}
• {"criterion_text":"- NYHA Class IV heart failure"}
• {"criterion_text":"- Patients with atrial fibrillation and poor rate control"}
• {"criterion_text":"- Contraindications to MR"}
• {"criterion_text":"- Previous history of contrast allergy of adverse reactions (gadolinium)"}
• {"criterion_text":"- Contraindications to tafamidis therapy"}
• {"criterion_text":"- Only for MIBG-scan: Tricyclic antidepressants (TCA) usage (most importantly amitriptyline, clomipramine, imipramine, nortriptyline, chlorpromazine or perphenazine)"}

Primary endpoints

• {"endpoint_text":"- Quantification of myocardial microcalcification on 18F-sodiumfluoride PET/CT and quantification of cardiac autonomic function on [123I]MIBG imaging.","definition_or_measurement_approach":"Measured using 18F-sodiumfluoride (18F-NaF) PET/CT for myocardial microcalcification and [123I]MIBG imaging for cardiac autonomic function; includes quantification of uptake measures (e.g. mean difference in [123I]MIBG uptake between early and progressive ATTR-CM at baseline and after one year on tafamidis)."}

Secondary endpoints

• {"endpoint_text":"- Change in myocardial microcalcification activity and myocardial innervation on 18F-sodiumfluoride PET/CT and [123I]-MIBG respectively","definition_or_measurement_approach":"Change over time assessed with serial 18F-NaF PET/CT (microcalcification activity) and [123I]-MIBG imaging (myocardial innervation)."}
• {"endpoint_text":"- Cardiac indices on magnetic resonance imaging, such as left ventricular ejection fraction, left ventricular mass, extracellular volume and global longitudinal strain","definition_or_measurement_approach":"Cardiac MRI-derived indices including LVEF, LV mass, ECV and global longitudinal strain measured by MRI."}
• {"endpoint_text":"- Cardiac biomarkers including NT-ProBNP and high-sensitivity cardiac troponin I","definition_or_measurement_approach":"Laboratory measurement of NT-proBNP and high-sensitivity cardiac troponin I."}
• {"endpoint_text":"- Clinical measures, such as 6MWT test, KCCQ-OS and Norfolk QOL‐DN","definition_or_measurement_approach":"Clinical functional tests and validated questionnaires: 6-minute walk test (6MWT), Kansas City Cardiomyopathy Questionnaire – Overall Summary (KCCQ-OS), Norfolk Quality of Life–Diabetic Neuropathy questionnaire (Norfolk QOL‐DN)."}

Netherlands

Earliest CTIS Part Ii Submission Date

16-09-2024

Latest Decision Or Authorization Date

19-09-2024

Processing Time Days

3

Number Of Sites

1

Number Of Participants

64

Primary sponsor

Full Name

Universitair Medisch Centrum Groningen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands