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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04862273
Other study ID # DL-L-20006_V16
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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