Status:

UNKNOWN

Native T1 CMR Imaging for Diagnosis of Cardiac Amyloidosis

Lead Sponsor:

University of Leipzig

Conditions:

Heart Failure NYHA Class II

Heart Failure NYHA Class III

Eligibility:

All Genders

60+ years

Brief 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 t...

Detailed 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 thick...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

April 1 2021

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

November 1 2024

Estimated Enrollment :

112 Patients enrolled

Trial Details

Trial ID

NCT04862273

Start Date

April 1 2021

End Date

November 1 2024

Last Update

November 29 2023

Active Locations (1)

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University of Leipzig

Leipzig, Saxony, Germany, 04103