NCT04862273

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 27, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.9 years

First QC Date

April 20, 2021

Last Update Submit

April 7, 2026

Conditions

Heart Failure NYHA Class IIHeart Failure NYHA Class IIIHeart Failure NYHA Class IVHeart Failure With Preserved Ejection FractionHeart Failure With Mid Range Ejection FractionHypertrophy, Left VentricularCardiac Amyloidosis

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of T1 mapping for diagnosis of CA

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

    up to 7 days

Secondary Outcomes (3)

  • Diagnostic accuracy of ATTR probability estimator to predict CA

    up to 7 days

  • Association of parametric T1 values with cardiovascular outcome

    1 year

  • Association of ATTR probability estimator values with cardiovascular outcome

    1 year

Study Arms (1)

CMR T1 mapping

Diagnostic accuracy of T1 mapping 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)

Diagnostic Test: Native T1 CMRDiagnostic Test: Web-based ATTR probability estimator (Pfizer, New York)Diagnostic Test: 99mTc-DPD scintigraphyDiagnostic Test: Laboratory screening for multiple myeloma / AL amyloidosisProcedure: Cardiac biopsy

Interventions

Native T1 CMRDIAGNOSTIC_TEST

Observed method

CMR T1 mapping
Web-based ATTR probability estimator (Pfizer, New York)DIAGNOSTIC_TEST

Observed method

CMR T1 mapping
99mTc-DPD scintigraphyDIAGNOSTIC_TEST

Reference method

CMR T1 mapping
Laboratory screening for multiple myeloma / AL amyloidosisDIAGNOSTIC_TEST

Reference method

CMR T1 mapping
Cardiac biopsyPROCEDURE

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

CMR T1 mapping

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with symptomatic heart failure (NYHA functional class II to IV, LVEF ≥40%), increased left ventricular wall thickness and elevated cardiac biomarkers

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leipzig

Leipzig, Saxony, 04103, Germany

Location

MeSH Terms

Conditions

Hypertrophy, Left VentricularAmyloid Neuropathies, Familial

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesHypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesNervous System DiseasesAmyloid NeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAmyloidosis, FamilialMetabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic DiseasesAmyloidosisProteostasis Deficiencies

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiologist

Study Record Dates

First Submitted

April 20, 2021

First Posted

April 27, 2021

Study Start

April 1, 2021

Primary Completion

March 1, 2023

Study Completion

December 1, 2024

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

DE(1)