Native T1 CMR Imaging for Diagnosis of Cardiac Amyloidosis

Heart Failure With Preserved Ejection Fraction Clinical Trial

— CMR for CA  

Official title:

Native T1 Cardiac Magnetic Resonance Imaging for Diagnosis of Cardiac Amyloidosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04862273
• Other study ID #: DL-L-20006_V16
• Status: Active, not recruiting
• Start date: April 1, 2021
• Est. completion date: November 2024

Study information

• Verified date: November 2023
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 112
• Est. completion date: November 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• Native T1 CMR
Observed method
• Web-based ATTR probability estimator (Pfizer, New York)
Observed method
• 99mTc-DPD scintigraphy
Reference method
• 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

Country	Name	City	State
Germany	University of Leipzig	Leipzig	Saxony

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of native T1 LV mapping for diagnosis of CA	Comparison native T1 CMR with the reference method for diagnosis of CA	up to 7 days
Secondary	Diagnostic accuracy of ATTR probability estimator to predict CA	Comparison of a probability score to predict ATTR with the final diagnosis of ATTR	up to 7 days
Secondary	Association of native T1 values with cardiovascular outcome	All-cause death, cardiovascular death and heart failure hospitalizations	1 years
Secondary	Association of ATTR probability estimator values with cardiovascular outcome	All-cause death, cardiovascular death and heart failure hospitalizations	1 year