Cardiac Amyloidosis, Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure NYHA Class IV, Heart Failure With Mid Range Ejection Fraction, Heart Failure With Preserved Ejection Fraction, Hypertrophy, Left Ventricular
Conditions
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.
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.
Interventions
DIAGNOSTIC_TESTNative T1 CMR
Observed method
DIAGNOSTIC_TESTWeb-based ATTR probability estimator (Pfizer, New York)
Observed method
DIAGNOSTIC_TEST99mTc-DPD scintigraphy
Reference method
DIAGNOSTIC_TESTLaboratory screening for multiple myeloma / AL amyloidosis
Reference method
PROCEDURECardiac biopsy
If non-invasive tests for CA (99mTc-DPD scintigraphy, biochemistry) are inconclusive
Sponsors
University of Leipzig
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of T1 mapping for diagnosis of CA | up to 7 days | Comparison of CMR T1 mapping to the reference method for diagnosis of CA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of ATTR probability estimator to predict CA | up to 7 days | Comparison of a probability score to predict ATTR with the final diagnosis of ATTR |
| Association of parametric T1 values with cardiovascular outcome | 1 year | All-cause death, cardiovascular death and heart failure hospitalizations |
| Association of ATTR probability estimator values with cardiovascular outcome | 1 year | All-cause death, cardiovascular death and heart failure hospitalizations |
Countries
Germany
Outcome results
None listed