CMR T1 Mapping for Diagnosis of Cardiac Amyloidosis (CMR for CA)

Native T1 Cardiac Magnetic Resonance Imaging 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.

Study Overview

• Status: Completed
• Conditions: Heart Failure NYHA Class II; Heart Failure NYHA Class III; Heart Failure With Preserved Ejection Fraction; Hypertrophy, Left Ventricular; Heart Failure NYHA Class IV; Cardiac Amyloidosis; Heart Failure With Mid Range Ejection Fraction
• Intervention / Treatment: Diagnostic test: Native T1 CMR; Diagnostic test: Web-based ATTR probability estimator (Pfizer, New York); Diagnostic test: 99mTc-DPD scintigraphy; Diagnostic test: Laboratory screening for multiple myeloma / AL amyloidosis; Procedure: Cardiac biopsy

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 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.

• Study Type: Observational
• Enrollment (Actual): 112

Contacts and Locations

Study Locations

• Germany
  • Saxony
    • Leipzig, Saxony, Germany, 04103
      • University of Leipzig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy of ATTR probability estimator to predict CA	Comparison of a probability score to predict ATTR with the final diagnosis of ATTR	up to 7 days
Association of ATTR probability estimator values with cardiovascular outcome	All-cause death, cardiovascular death and heart failure hospitalizations	1 year
Association of parametric T1 values with cardiovascular outcome	All-cause death, cardiovascular death and heart failure hospitalizations	1 year

Collaborators and Investigators

• Sponsor: University of Leipzig

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): December 1, 2024

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 27, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Diseases; Neuromuscular Diseases; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Peripheral Nervous System Diseases; Neurodegenerative Diseases; Heredodegenerative Disorders, Nervous System; Proteostasis Deficiencies; Cardiomegaly; Amyloid Neuropathies; Amyloidosis, Familial; Hypertrophy; Amyloidosis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Hypertrophy, Left Ventricular; Amyloid Neuropathies, Familial
• Other Study ID Numbers: DL-L-20006_V16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No