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CMR T1 Mapping for Diagnosis of Cardiac Amyloidosis

NCT04862273 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 112

Last updated 2026-04-13

No results posted yet for this study

Summary

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.

Conditions

  • 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

Interventions

DIAGNOSTIC_TEST

Native T1 CMR

Observed method

DIAGNOSTIC_TEST

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

Observed method

DIAGNOSTIC_TEST

99mTc-DPD scintigraphy

Reference method

DIAGNOSTIC_TEST

Laboratory screening for multiple myeloma / AL amyloidosis

Reference method

PROCEDURE

Cardiac biopsy

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

Sponsors & Collaborators

  • University of Leipzig

    lead OTHER

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2023-03-01
Completion
2024-12-01

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04862273 on ClinicalTrials.gov