An observational study in Heart Failure NYHA Class II, Heart Failure NYHA Class III and Heart Failure NYHA Class IV, sponsored by University of Leipzig. Completed at 1 site in Germany. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by University of Leipzig · Observational
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.
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.
162 studies on the registry are indexed under Hypertrophy, Left Ventricular; 28 are open to participants now.
This study's enrollment of 112 is below the median of 198 across 60 observational studies indexed under Hypertrophy, Left Ventricular.
Browse Hypertrophy, Left Ventricular studies →University of Leipzig is the lead sponsor of 148 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with symptomatic heart failure (NYHA functional class II to IV, LVEF ≥40%), increased left ventricular wall thickness and elevated cardiac biomarkers
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · 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
Observed method
Observed method
Reference method
Reference method
If non-invasive tests for CA (99mTc-DPD scintigraphy, biochemistry) are inconclusive
Diagnostic accuracy of T1 mapping for diagnosis of CA
Comparison of CMR T1 mapping to the reference method for diagnosis of CA
Time frame: up to 7 days
Diagnostic accuracy of ATTR probability estimator to predict CA
Comparison of a probability score to predict ATTR with the final diagnosis of ATTR
Time frame: up to 7 days
Association of parametric T1 values with cardiovascular outcome
All-cause death, cardiovascular death and heart failure hospitalizations
Time frame: 1 year
Association of ATTR probability estimator values with cardiovascular outcome
All-cause death, cardiovascular death and heart failure hospitalizations
Time frame: 1 year
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Apr 2021 to primary completion in Mar 2023, 23 months.
Of 18 observational studies under Hypertrophy, Left Ventricular, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 58. This study's 23 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Hypertrophy, Left Ventricular →