Clinical trial NCT04862273: Native T1 CMR Imaging for Diagnosis of Cardiac Amyloidosis
Official title: Native T1 Cardiac Magnetic Resonance Imaging for Diagnosis of Cardiac Amyloidosis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 112
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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 tesla CMR) 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.

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, native 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 native T1 mapping with the threshold of 1341ms 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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic accuracy of native T1 LV mapping for diagnosis of CA
timeFrame: up to 7 days
Secondary outcomes:
measure: Diagnostic accuracy of ATTR probability estimator to predict CA
timeFrame: up to 7 days
measure: Association of native T1 values with cardiovascular outcome
timeFrame: 1 years
measure: Association of ATTR probability estimator values with cardiovascular outcome
timeFrame: 1 year
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig
state: Saxony
Study officials:
References: