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i-Care; Quantitative-imaging in cardiac transthyretin amyloidosis
EU CTIS ID: 2024-513310-36-01
What this study is testing
Quantification of myocardial microcalcification on 18F-sodiumfluoride PET/CT Mean difference in [123I]MIBG uptake between early and progressive ATTR-CM at baseline and after one years on tafamidis.
- 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
- Completion of informed consent
- Age > 40 years for patients with ATTR or AL cardiac amyloidosis and age >30 years for patients with HCM
- 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
You likely can't join if
- Inability or unwilling to give informed consent
- Only for MIBG-scan: Parkinson’s disease as mentioned in patients’ medical history
- Only for MIBG-scan: Insulin dependent diabetes mellitus as shown in patients’ actual medication list
- 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
- Renal dysfunction (eGFR ≤30 mL/min/1.73m2)
- NYHA Class IV heart failure
See the full eligibility criteria
- Completion of informed consent
- Age > 40 years for patients with ATTR or AL cardiac amyloidosis and age >30 years for patients with HCM
- 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
- Inability or unwilling to give informed consent
- Only for MIBG-scan: Parkinson’s disease as mentioned in patients’ medical history
- Only for MIBG-scan: Insulin dependent diabetes mellitus as shown in patients’ actual medication list
- 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
- Renal dysfunction (eGFR ≤30 mL/min/1.73m2)
- NYHA Class IV heart failure
- Patients with atrial fibrillation and poor rate control
- Contraindications to MR
- Previous history of contrast allergy of adverse reactions (gadolinium)
- Contraindications to tafamidis therapy
- Only for MIBG-scan: Tricyclic antidepressants (TCA) usage (most importantly amitriptyline, clomipramine, imipramine, nortriptyline, chlorpromazine or perphenazine)
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 all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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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.