Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04862273
Study type Observational
Source University of Leipzig
Contact Daniel Lavall, MD
Phone +493419712650
Email [email protected]
Status Recruiting
Phase
Start date April 2021
Completion date December 2023

See also
  Status Clinical Trial Phase
Not yet recruiting NCT04535726 - The Relationship Between Blood Pressure and Arterial Stiffness in HFpEF Patients With Different Levels of Obesity
Recruiting NCT04153136 - Effects of Sacubitril/Valsartan on Subclinical Heart Failure in HIV (The ENCHANTMENT HIV Study) Phase 2
Recruiting NCT04594499 - The Relationship Between Pericardial Fat Thickness and Arterial Stiffness in HFpEF Patients
Recruiting NCT03550235 - Exploration of Dyspnea at Non-high Brain Natriuretic Peptide (BNP)
Recruiting NCT04633460 - Acute Effects of Exogenous Ketone Ester Administration in Heart Failure Phase 2
Completed NCT01726049 - Sildenafil in HFpEF and PH Phase 3
Completed NCT01185067 - Physiological Effects of Grape Seed Extract in Diastolic Heart Failure Phase 1
Completed NCT01091467 - Prospective Study of Heart Failure With Preserved Left Ventricular Ejection Fraction
Recruiting NCT04237701 - Real-Time Monitoring of Heart Failure Across the Yale New Haven Health System
Completed NCT03254485 - A Study of the Effect of IW-1973 on the Exercise Capacity of Patients With Heart Failure With Preserved Ejection Fraction (HFpEF) Phase 2
Recruiting NCT02901184 - Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction Phase 3
Completed NCT01618981 - LEft Atrial Pacing in Diastolic Heart Failure N/A
Recruiting NCT04886713 - Adipose Tissue Inflammation in HFpEF
Active, not recruiting NCT04019613 - Assessment of Pulmonary Congestion During Cardiac Hemodynamic Stress Testing N/A
Recruiting NCT04727073 - Spironolactone In The Treatment of Heart Failure Phase 3
Completed NCT03837470 - Evaluation of Renal Sodium Excretion After Salt Loading in Heart Failure With Preserved Ejection Fraction Early Phase 1
Completed NCT04163861 - Frequency and Magnitude of Subclinical Systolic Dysfunction by Strain Imaging in Heart Failure With Preserved Ejection Fraction
Not yet recruiting NCT04318145 - Study to Evaluate Sex Differences in the Acute Effects of PL-3994 in Heart Failure Subjects Phase 2
Not yet recruiting NCT04506606 - Cardiac Rehab Effects in HFpEF N/A
Not yet recruiting NCT04820556 - Gut Microbiota in Chronic Noncommunicable Diseases