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Native T1 CMR Imaging for Diagnosis of Cardiac Amyloidosis

NCT ID: NCT04862273

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

112 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-01

Study Completion Date

2024-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Native T1 CMR

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)

Native T1 CMR

Intervention Type DIAGNOSTIC_TEST

Observed method

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

Intervention Type DIAGNOSTIC_TEST

Observed method

99mTc-DPD scintigraphy

Intervention Type DIAGNOSTIC_TEST

Reference method

Laboratory screening for multiple myeloma / AL amyloidosis

Intervention Type DIAGNOSTIC_TEST

Reference method

Cardiac biopsy

Intervention Type PROCEDURE

If non-invasive tests for CA (99mTc-DPD scintigraphy, biochemistry) are inconclusive

Interventions

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Native T1 CMR

Observed method

Intervention Type DIAGNOSTIC_TEST

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

Observed method

Intervention Type DIAGNOSTIC_TEST

99mTc-DPD scintigraphy

Reference method

Intervention Type DIAGNOSTIC_TEST

Laboratory screening for multiple myeloma / AL amyloidosis

Reference method

Intervention Type DIAGNOSTIC_TEST

Cardiac biopsy

If non-invasive tests for CA (99mTc-DPD scintigraphy, biochemistry) are inconclusive

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Leipzig

OTHER

Sponsor Role lead

Responsible Party

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Daniel Lavall

Cardiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Leipzig

Leipzig, Saxony, Germany

Site Status

Countries

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Germany

Other Identifiers

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DL-L-20006_V16

Identifier Type: -

Identifier Source: org_study_id