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OpenTrials
Completed

NCT Number: NCT04862273

CMR T1 Mapping for Diagnosis of Cardiac Amyloidosis

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.

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Key information

About this study

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, 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 T1 mapping 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Native T1 CMR

Diagnostic Test

Observed method

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

Diagnostic Test

Observed method

99mTc-DPD scintigraphy

Diagnostic Test

Reference method

Laboratory screening for multiple myeloma / AL amyloidosis

Diagnostic Test

Reference method

Cardiac biopsy

Procedure

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

Primary outcomes

  1. Diagnostic accuracy of T1 mapping for diagnosis of CA

    Time frame: up to 7 days

    Comparison of CMR T1 mapping to the reference method for diagnosis of CA

Secondary outcomes

  1. Diagnostic accuracy of ATTR probability estimator to predict CA

    Time frame: up to 7 days

    Comparison of a probability score to predict ATTR with the final diagnosis of ATTR

  2. Association of parametric T1 values with cardiovascular outcome

    Time frame: 1 year

    All-cause death, cardiovascular death and heart failure hospitalizations

  3. Association of ATTR probability estimator values with cardiovascular outcome

    Time frame: 1 year

    All-cause death, cardiovascular death and heart failure hospitalizations

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Registry information

Official study title

Native T1 Cardiac Magnetic Resonance Imaging for Diagnosis of Cardiac Amyloidosis

Acronym: CMR for CA

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Apr 27, 2021
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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