NCT04862273

CMR T1 Mapping for Diagnosis of Cardiac Amyloidosis

Native T1 Cardiac Magnetic Resonance Imaging for Diagnosis of Cardiac Amyloidosis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 112 (actual)
• Sponsor: University of Leipzig · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

The study aims to test the diagnostic accuracy of T1 mapping for the diagnosis of cardiac amyloidosis prospectively. The hypothesis is that T1 mapping in older patients with symptomatic heart failure, increased LV wall thickness and elevated cardiac biomarkers is non-inferior to the reference method to diagnose cardiac amyloidosis (CA). As secondary measure, a web-based ATTR probability estimator for the diagnosis of CA will be evaluated.

Detailed description

Cardiac amyloidosis (CA) is an important differential diagnosis in older patients with symptomatic heart failure with preserved or mid-range ejection fraction and increased left ventricular wall thickness. The prevalence of CA among patients with heart failure and left ventricular (LV) hypertrophy is approximately 13%. However, diagnosis of CA is challenging because specific clinical signs are often lacking. Amyloid fibrils deposit in the extracellular space of the myocardium increases myocardial T1 values on cardiac magnetic resonance (CMR). Therefore, T1 imaging provides a promising non-invasive method to identify CA. A preliminary retrospective analysis of 128 patients with increased LV wall thickness identified an area under the curve of 0.9954 (p\<0.0001) for native T1 to detect CA. The optimal cut-off value was 1341ms, with a sensitivity of 100% and a specificity of 97%. The investigators aim to test the diagnostic accuracy of T1 mapping for the diagnosis of CA compared to the reference method prospectively. Moreover, the web-based ATTR probability estimator for the diagnosis of CA will be evaluated.

Conditions

• Heart Failure NYHA Class II
• Heart Failure NYHA Class III
• Heart Failure NYHA Class IV
• Heart Failure With Preserved Ejection Fraction
• Heart Failure With Mid Range Ejection Fraction
• Hypertrophy, Left Ventricular
• Cardiac Amyloidosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Native T1 CMR	Observed method
DIAGNOSTIC_TEST	Web-based ATTR probability estimator (Pfizer, New York)	Observed method
DIAGNOSTIC_TEST	99mTc-DPD scintigraphy	Reference method
DIAGNOSTIC_TEST	Laboratory screening for multiple myeloma / AL amyloidosis	Reference method
PROCEDURE	Cardiac biopsy	If non-invasive tests for CA (99mTc-DPD scintigraphy, biochemistry) are inconclusive

Timeline

• Start date: 2021-04-01
• Primary completion: 2023-03-01
• Completion: 2024-12-01
• First posted: 2021-04-27
• Last updated: 2026-04-13

Locations

1 site across 1 country: Germany