Quantitative-imaging in cardiac transthyretin amyloidosis (I-CARE)

Recruiting

Conditions: cardiac amyloidosis
hart amyloidstapeling
10028593

Registration Number: NL-OMON55211

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 70

Inclusion Criteria

• Completion of informed consent • Age > 18 years • ATTR cardiac amyloid
according to Expert Consensus Recommendations • AL amyloidosis according to
Expert Consensus Recommendations • Hypertrophic cardiomyopathy according to
European Society of Cardiology guidelines

Exclusion Criteria

• Inability or unwilling to give informed consent
• 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

With regards to patient exclusion for solely 1[23I]MIBG scan:
• Tricyclic antidepressants (TCA) usage (most importantly amitriptyline,
clomipramine, imipramine, nortriptyline, chlorpromazine or perphenazine);
• Parkinson*s disease as mentioned in patients* medical history;
• Insulin dependent diabetes mellitus as shown in patients* actual medication
list.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoints<br /><br>• Quantification of myocardial microcalcification on 18F-sodiumfluoride PET/CT;<br /><br>• Mean difference in [123I]MIBG uptake between early and progressive ATTR-CM at<br /><br>baseline and after one years on tafamidis.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Endpoints<br /><br>• Change in myocardial microcalcification activity on 18F-sodiumfluoride PET/CT;<br /><br>• Cardiac indices on magnetic resonance imaging, such as left ventricular<br /><br>ejection fraction, left ventricular mass, extracellular volume and global<br /><br>longitudinal strain;<br /><br>• Cardiac biomarkers including NT-ProBNP and high-sensitivity cardiac troponin<br /><br>I;<br /><br>• Clinical measures such as 6-minute walk test (6MWT), Kansas City<br /><br>Cardiomyopathy Questionnaire - Overall Summary (KCCQ-OS) score, and Norfolk<br /><br>Quality of Life-Diabetic Neuropathy questionnaire total score (Norfolk QOL*DN); </p><br>