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COMPLETED
NCT04862273

CMR T1 Mapping for Diagnosis of Cardiac Amyloidosis

Sponsor: University of Leipzig

View on ClinicalTrials.gov

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.

Official title: Native T1 Cardiac Magnetic Resonance Imaging for Diagnosis of Cardiac Amyloidosis

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

OBSERVATIONAL

Enrollment

112

Start Date

2021-04-01

Completion Date

2024-12-01

Last Updated

2026-04-13

Healthy Volunteers

No

Conditions

Heart Failure NYHA Class IIHeart Failure NYHA Class IIIHeart Failure NYHA Class IVHeart Failure With Preserved Ejection FractionHeart Failure With Mid Range Ejection FractionHypertrophy, Left VentricularCardiac Amyloidosis

Interventions

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

Locations (1)

University of Leipzig

Leipzig, Saxony, Germany