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Heart FailureT1Outcome-DENCT03749343

International T1 Multicenter Outcome Study

An observational study of Heart Failure and Cardiomyopathies, run by Johann Wolfgang Goethe University Hospital at 2 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Mapping of magnetic relaxation within the myocardial tissue using T1 (and T2) mapping using cardiovascular magnetic resonance (CMR) are novel measures of quantifiable (scalable) myocardial tissue characterisation. Read more about this study

Who is it for?
Ages 18 years and older
How many people
8,000 participants
Where
2 sitesGermany
Study dates
1 Mar 2016to 28 Feb 2030
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Adults referred to clinical cardiac magnetic resonance imaging

Who may be able to join

  • Adults (>18 years of age)
  • Able to provide informed consent
  • Clinically indicated cardiac magnetic resonance imaging study
  • Exclusion Criteria: contraindications for clinical cardiac magnetic resonance imaging due to MR unsafe devices or objects

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Kerckhoff Hospital

    Bad Nauheim, Hesse, 61231

  • Institute for experimental and translational cardiovascular imaging

    Frankfurt am Main, Hesse, 60596

Other trials in Germany

About this study

Official title: International T1 Multicenter Outcome Study (the German Chapter)

Mapping of magnetic relaxation within the myocardial tissue using T1 (and T2) mapping using cardiovascular magnetic resonance (CMR) are novel measures of quantifiable (scalable) myocardial tissue characterisation. Evidence suggests that myocardial mapping could be useful in detection of diffuse myocardial disease, complementing late gadolinium enhancement (LGE) as the tool for regional myocardial disease. A handful of studies, three single centre study of a single T1 index with outcomes and one multicentre study for all indices reported strong associations with all cause mortality and heart failure. These studies were based on a single-vendor platform and were using a single sequence. The main unknowns pertaining the successful translation of this technique and the transferability of the methodology beyond a single centre and lack of outcome evidence from broad and large populations. In this study, we will assess the diagnostic accuracy of T1 (and T2) mapping measurements in health and disease, and the prognostic relevance of T1 mapping measurements by associations with outcome. This study is builds upon/integrates the evidence of the NCT02407197 study, which remains active for follow-up, but is currently no longer recruiting.

Keywords
T1 mapping, native T1, native T2, accuracy, prognosis
Medical subject headings
Heart Failure, Cardiomyopathies, Coronary Artery Disease, Renal Insufficiency, Chronic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival

    number of deaths

    Measured: 1 year

  2. Survival

    number of deaths

    Measured: 5 year

Secondary outcomes (6)

  1. Rate of Heart Failure events

    Number of participants with events including death and Hospitalisation due to Heart Failure

    Measured: 1 year

  2. Rate of Heart Failure events

    Number of participants with events including death and Hospitalisation due to Heart Failure

    Measured: 5 year

  3. Rate of Arrhythmia

    Number of participants with events of documented Sudden Cardiac Death, appropriate ICD discharge, sustained VT

    Measured: 1 year

  4. Rate of Arrhythmia

    Number of participants with events including documented Sudden Cardiac Death, appropriate ICD discharge, sustained VT

    Measured: 5 year

  5. Rate of death due to to cardiovascular causes

    Number of participants with death due to myocardial infarction, heart failure, arrhythmia

    Measured: 1 year

  6. Rate of death due to to cardiovascular causes

    Number of participants with death due to myocardial infarction, heart failure, arrhythmia

    Measured: 5 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2018
  2. Study start1 Mar 2016
  3. Primary completion28 Feb 2030 (estimated)
  4. Study completion28 Feb 2030 (estimated)

Resources

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
8,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03749343
Sponsor's protocol ID
T1 Outcome 1/16gA
Acronym
T1Outcome-DE
Status last verified
Jan 2026
First submitted
16 Nov 2018
Last updated
6 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Puntmann VO, Carr-White G, Jabbour A, Yu CY, Gebker R, Kelle S, Rolf A, Zitzmann S, Peker E, D'Angelo T, Pathan F, Elen, Valbuena S, Hinojar R, Arendt C, Narula J, Herrmann E, Zeiher AM, Nagel E; International T1 Multicentre CMR Outcome Study. Native T1 and ECV of Noninfarcted Myocardium and Outcome in Patients With Coronary Artery Disease. J Am Coll Cardiol. 2018 Feb 20;71(7):766-778. doi: 10.1016/j.jacc.2017.12.020.

    PubMed 29447739

  • Winau L, Hinojar Baydes R, Braner A, Drott U, Burkhardt H, Sangle S, D'Cruz DP, Carr-White G, Marber M, Schnoes K, Arendt C, Klingel K, Vogl TJ, Zeiher AM, Nagel E, Puntmann VO. High-sensitive troponin is associated with subclinical imaging biosignature of inflammatory cardiovascular involvement in systemic lupus erythematosus. Ann Rheum Dis. 2018 Nov;77(11):1590-1598. doi: 10.1136/annrheumdis-2018-213661. Epub 2018 Aug 4.

    PubMed 30077990

  • Haslbauer JD, Lindner S, Valbuena-Lopez S, Zainal H, Zhou H, D'Angelo T, Pathan F, Arendt CA, Bug G, Serve H, Vogl TJ, Zeiher AM, Carr-White G, Nagel E, Puntmann VO. CMR imaging biosignature of cardiac involvement due to cancer-related treatment by T1 and T2 mapping. Int J Cardiol. 2019 Jan 15;275:179-186. doi: 10.1016/j.ijcard.2018.10.023. Epub 2018 Oct 11.

    PubMed 30360992

  • de Leuw P, Arendt CT, Haberl AE, Froadinadl D, Kann G, Wolf T, Stephan C, Schuettfort G, Vasquez M, Arcari L, Zhou H, Zainal H, Gawor M, Vidalakis E, Kolentinis M, Albrecht MH, Escher F, Vogl TJ, Zeiher AM, Nagel E, Puntmann VO. Myocardial Fibrosis and Inflammation by CMR Predict Cardiovascular Outcome in People Living With HIV. JACC Cardiovasc Imaging. 2021 Aug;14(8):1548-1557. doi: 10.1016/j.jcmg.2021.01.042. Epub 2021 Apr 14.

    PubMed 33865770

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure and Cardiomyopathies, run by Johann Wolfgang Goethe University Hospital at 2 sites 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 4 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

This study is still under way. Results are not available in the source record yet.

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?

Survival (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT03749343, which also lists 4 linked publications.

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 6 Jan 2026.

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