Native T1 CMR Imaging for Diagnosis of Cardiac Amyloidosis (CMR for CA)

University of Leipzig

Status: Active, not recruiting

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

Treatments: Procedure: Cardiac biopsy; Diagnostic Test: Native T1 CMR; Diagnostic Test: Web-based ATTR probability estimator (Pfizer, New York); Diagnostic Test: 99mTc-DPD scintigraphy; Diagnostic Test: Laboratory screening for multiple myeloma / AL amyloidosis

Study type: Observational

Funder types: Other

Identifiers

NCT04862273

DL-L-20006_V16

Details and patient eligibility

About

The study aims to test the diagnostic accuracy of native T1 mapping for the diagnosis of cardiac amyloidosis prospectively. The hypothesis is that native T1 mapping with a cut-off value of 1341ms (3 tesla CMR) 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.

Full 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, native 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 native T1 mapping with the threshold of 1341ms 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.

Enrollment: 112 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 60 years
• Symptomatic heart failure (NYHA II-IV) with LVEF ≥40%
• Increased LV wall thickness (≥12mm end-diastolic)
• NT-proBNP ≥1000pg/mL
• Elevated hs-troponin T ≥14ng/L

Exclusion criteria

• Contraindications for CMR
• Acute myocarditis
• Acute myocardial infarction <1 month
• Severe aortic stenosis and RAISE score < 2 points

Trial design

112 participants in 1 patient group

Native T1 CMR

Description:

Diagnostic accuracy of native T1 CMR and ATTR probability estimator are tested against the reference methods (99mTc-DPD scintigraphy, laboratory screening for multiple myeloma / AL amyloidosis; or cardiac biopsy, if noninvasive evaluation is inconclusive)

Treatment:

Diagnostic Test: Web-based ATTR probability estimator (Pfizer, New York)

Diagnostic Test: 99mTc-DPD scintigraphy

Diagnostic Test: Laboratory screening for multiple myeloma / AL amyloidosis

Procedure: Cardiac biopsy

Diagnostic Test: Native T1 CMR