University of Leipzig
Leipzig, Saxony, 04103, Germany
NCT Number: NCT04862273
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.
Looking for future studies?
Notify Me60 year and older
All sexes
Observational
Leipzig, Saxony, 04103, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Observed method
Observed method
Reference method
Reference method
If non-invasive tests for CA (99mTc-DPD scintigraphy, biochemistry) are inconclusive
Time frame: up to 7 days
Comparison of CMR T1 mapping to the reference method for diagnosis of CA
Time frame: up to 7 days
Comparison of a probability score to predict ATTR with the final diagnosis of ATTR
Time frame: 1 year
All-cause death, cardiovascular death and heart failure hospitalizations
Time frame: 1 year
All-cause death, cardiovascular death and heart failure hospitalizations
University of Leipzig
Other
Native T1 Cardiac Magnetic Resonance Imaging for Diagnosis of Cardiac Amyloidosis
Acronym: CMR for CA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03387813
Cardiovascular Diseases, Heart Diseases
Phoenix, Arizona, United States
View Trial DetailsNCT04180696
Arrhythmias, Cardiac, Bundle-Branch Block
Bandar Seri Begawan, Brunei
View Trial DetailsNCT05835063
Heart Failure NYHA Class II, Heart Failure NYHA Class III
Ann Arbor, Michigan, United States
View Trial DetailsNCT06641284
Behavior, Cardiovascular Diseases
Al ‘Usaylah, Saudi Arabia
View Trial Details