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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55211

Enrollment

Registered

2021-02-25

Start date

2022-08-25

Completion date

Unknown

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiac amyloidosis hart amyloidstapeling

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Primary Endpoints • 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.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results