Heart Failure NYHA Class IICMR for CANCT04862273
CMR T1 Mapping for Diagnosis of Cardiac Amyloidosis
An observational study of Heart Failure NYHA Class II and Heart Failure NYHA Class III, run by University of Leipzig at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure NYHA Class IV
- What is being tested?
- Native T1 CMR, Web-based ATTR probability estimator (Pfizer, New York) and 99mTc-DPD scintigraphy
- Type of treatment
- Surgery or procedure
- How many people
- 112 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2021to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with symptomatic heart failure (NYHA functional class II to IV, LVEF ≥40%), increased left ventricular wall thickness and elevated cardiac biomarkers
Who may be able to join
- 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
Who cannot join
- Contraindications for CMR
- Acute myocarditis
- Acute myocardial infarction <1 month
- Severe aortic stenosis and RAISE score < 2 points
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Native T1 Cardiac Magnetic Resonance Imaging for Diagnosis of Cardiac Amyloidosis
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.
Read the 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.
- 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
- Being tested
- Native T1 CMR, Web-based ATTR probability estimator (Pfizer, New York), 99mTc-DPD scintigraphy, Laboratory screening for multiple myeloma / AL amyloidosis, Cardiac biopsy
- Medical subject headings
- Hypertrophy, Left Ventricular, Amyloid Neuropathies, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Native T1 CMRDiagnostic test
Observed method
Web-based ATTR probability estimator (Pfizer, New York)Diagnostic test
Observed method
99mTc-DPD scintigraphyDiagnostic test
Reference method
Laboratory screening for multiple myeloma / AL amyloidosisDiagnostic test
Reference method
Cardiac biopsyProcedure or surgery
If non-invasive tests for CA (99mTc-DPD scintigraphy, biochemistry) are inconclusive
| Study group | Role | What they receive |
|---|---|---|
| CMR T1 mapping | 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) Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of T1 mapping for diagnosis of CA
Comparison of CMR T1 mapping to the reference method for diagnosis of CA
Measured: up to 7 days
Secondary outcomes (3)
Diagnostic accuracy of ATTR probability estimator to predict CA
Comparison of a probability score to predict ATTR with the final diagnosis of ATTR
Measured: up to 7 days
Association of parametric T1 values with cardiovascular outcome
All-cause death, cardiovascular death and heart failure hospitalizations
Measured: 1 year
Association of ATTR probability estimator values with cardiovascular outcome
All-cause death, cardiovascular death and heart failure hospitalizations
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start1 Apr 2021
- Primary completion1 Mar 2023
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure NYHA Class IIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Lavall, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862273
- Sponsor's protocol ID
- DL-L-20006_V16
- Acronym
- CMR for CA
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2021
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Unger L, Gessner R, Stegmann T, Hagendorff A, Tiepolt S, Sabri O, Ebel S, Denecke T, Laufs U, Lavall D. Cardiac magnetic resonance T1 mapping for amyloid cardiomyopathy in patients with heart failure. Eur Heart J Imaging Methods Pract. 2026 Jul 23;4(3):qyag131. doi: 10.1093/ehjimp/qyag131. eCollection 2026 Aug.
PubMed 42662629
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Native T1 Cardiac Magnetic Resonance Imaging for Diagnosis of Cardiac Amyloidosis
- ClinicalTrials.gov ID
- NCT04862273
- Acronym / sponsor ID
- CMR for CA / DL-L-20006_V16
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 27 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CMR T1 mapping | – | 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 biopsyDiagnostic 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) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic heart failure (NYHA functional class II to IV, LVEF ≥40%), increased left ventricular wall thickness and elevated cardiac biomarkers
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Contraindications for CMR
- Acute myocarditis
- Acute myocardial infarction <1 month
- Severe aortic stenosis and RAISE score < 2 points
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Native T1 CMRObserved method | Diagnostic test | CMR T1 mapping |
| Web-based ATTR probability estimator (Pfizer, New York)Observed method | Diagnostic test | CMR T1 mapping |
| 99mTc-DPD scintigraphyReference method | Diagnostic test | CMR T1 mapping |
| Laboratory screening for multiple myeloma / AL amyloidosisReference method | Diagnostic test | CMR T1 mapping |
| Cardiac biopsyIf non-invasive tests for CA (99mTc-DPD scintigraphy, biochemistry) are inconclusive | Procedure or surgery | CMR T1 mapping |
Primary outcome
Diagnostic accuracy of T1 mapping for diagnosis of CA
Time frame: up to 7 days
Comparison of CMR T1 mapping to the reference method for diagnosis of CA
3 secondary outcomes
Diagnostic accuracy of ATTR probability estimator to predict CA
Time frame: up to 7 days
Association of parametric T1 values with cardiovascular outcome
Time frame: 1 year
Association of ATTR probability estimator values with cardiovascular outcome
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Derived from this study: PubMed 42662629Unger L, Gessner R, Stegmann T, Hagendorff A, Tiepolt S, Sabri O, Ebel S, Denecke T, Laufs U, Lavall D. Cardiac magnetic resonance T1 mapping for amyloid cardiomyopathy in patients with heart failure. Eur Heart J Imaging Methods Pract. 2026 Jul 23;4(3):qyag131. doi: 10.1093/ehjimp/qyag131. eCollection 2026 Aug.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure NYHA Class II and Heart Failure NYHA Class III, run by University of Leipzig at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of T1 mapping for diagnosis of CA (time frame: up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04862273, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.