AzTrials
AzTrials

Acute Heart FailureCYCLENCT07508891

Characterisation of phenotYpes in aCute Heart faiLure patiEnts

An observational study of Acute Heart Failure and Decompensated Heart Failure, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

An observational cohort study to evaluate the benefit of functional parameters, radiomics and blood biomarkers to predict the outcome of patients with acute heart failure. Read more about this study

Who is it for?
Ages 18 years and older
How many people
1,000 participants
Where
1 siteGermany
Study dates
1 Mar 2019to 31 Dec 2030
How long will I take part?
10 Years
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
  • No healthy volunteers
  • Adult, Older adult

Study population: Hospitalised patients with acute heart failure of any aetiology and stage at a German tertiary care centre.

Who may be able to join

  • Clinical diagnosis of acute heart failure, including all stages of cardiogenic shock, de novo heart failure as well as decompensated chronic heart failure.
  • Hospitalisation due to acute heart failure or new-onset acute heart failure during a hospitalisation de to a different cause. Out-patients with acute heart failure are not included.

Who cannot join

  • Age < 18 years
  • No written informed consent.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Benedikt Schrage, MD, PhD contact

+49 40 7410 0

b.schrage@uke.de

Christina Magnussen, MD contact

+49 40 7410 0

c.magnussen@uke.de

Germany1 site, 1 recruiting

  • University Medical Center Hamburg-Eppendorf

    Hamburg, 20246

    Benedikt N Schrage, MD, PhD, +49 40 7410 0, b.schrage@uke.de

    Christina Magnussen, MD, +49 40 7410 0, c.magnussen@uke.de

    Recruiting

Other trials in Germany

About this study

An observational cohort study to evaluate the benefit of functional parameters, radiomics and blood biomarkers to predict the outcome of patients with acute heart failure.

Read the detailed description

Heart failure is a condition with both a high burden of morbidity and mortality. Cases of acute heart failure are frequent in A\&E departments and a common reason for hospitalisation.

The primary aim of this prospective, monocentric cohort study is to characterise distinct phenotypes of patients with acute heart failure (including all stages of cardiogenic shock) and to identify functional, radiological and circulating biomarkers to improve risk prediction for the individual patient. Hypotheses to inform future trial design will be generated. Biobanking is included to allow for future assessment of novel biomarkers.

Keywords
cardiogenic shock, acute heart failure, heart failure, biomarker, biobank, cohort study, phenotyping, risk prediction
Medical subject headings
Shock, Cardiogenic, Heart Failure

What is being measured

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

  1. Time to cardiovascular death or first rehospitalisation for heart failure

    Etiologies of death and hospitalisation will be adjudicated by local investigators. Time-to-event analyses are planned for the primary outcome.

    Measured: from enrolment up to 5 years

Secondary outcomes (9)

  1. Incidence rate of cardiovascular death and total rehospitalisations for heart failure

    Etiologies will be adjudicated by local investigators. Repeated event analyses are planned for this secondary outcome.

    Measured: from enrolment up to 5 years

  2. Time to cardiovascular death

    Cause of death adjudicated by local investigators. Time-to-event analysis.

    Measured: from enrolment up to 5 years

  3. Time to first rehospitalisation for heart failure

    Etiologies will be adjudicated by local investigators. Time-to-event analyses are planned.

    Measured: from enrolment up to 5 years

  4. Incidence rate of total rehospitalisations for heart failure

    Etiologies will be adjudicated by local investigators. Repeated event analyses are planned.

    Measured: from enrolment up to 5 years

  5. Incidence rate of progression of cardiogenic shock

    Defined as progression to higher SCAI stage.

    Measured: within index hospitalisation (enrolment to discharge or death)

  6. Incidence rate of total severe bleeding events

    Defined as BARC 3-5. Repeated event analyses are planned.

    Measured: within index hospitalisation (enrolment to discharge or death)

  7. Incidence rate of new onset of long-term renal replacement therapy

    Need for new long-term renal replacement therapy due to terminal renal failure. Including patients with medical indication but without implementation due to revised goals of care. Excluding patients with previous renal replacement therapy.

    Measured: within index hospitalisation (enrolment to discharge or death)

  8. Incidence rate of total severe peripheral or abdominal ischaemia events

    Severe ischaemia is defined by indication for interventional or surgical treatment, judged by the local investigators. Patients with indication but without procedure due to changed goals of care are included. Repeated event analyses are planned.

    Measured: within index hospitalisation (enrolment to discharge or death)

  9. Incidence rate of hypoxic brain injury diagnosis

    New onset of hypoxic brain injury, defined as CPC 3-5. Patients with previous hypoxic brain injury are excluded from the analysis. Death is classified as CPC 5.

    Measured: assessed at discharge from index hospitalisation

Timeline

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

  1. First posted2 Apr 2026
  2. Study start1 Mar 2019
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 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
1,000 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07508891
Sponsor's protocol ID
CYCLE
Acronym
CYCLE
Status last verified
Mar 2026
First submitted
30 Dec 2025
Last updated
2 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kriz M, Kellner C, Beer BN, Sundermeyer J, Dettling A, Besch L, Benesch Vidal ML, Becher N, Savarese G, Kirchhof P, Blankenberg S, Magnussen C, Schrage B, Becher PM. Early rhythm control in patients with acute decompensated heart failure: results from the CYCLE cohort study. Europace. 2025 Dec 1;27(12):euaf314. doi: 10.1093/europace/euaf314. No abstract available.

    PubMed 41342526

  • Beer BN, Keshtkaran S, Kellner C, Besch L, Sundermeyer J, Dettling A, Kirchhof P, Blankenberg S, Magnussen C, Schrage B. Pro-adrenomedullin associates with congestion in acute heart failure patients. ESC Heart Fail. 2024 Dec;11(6):3598-3606. doi: 10.1002/ehf2.15007. Epub 2024 Aug 20.

    PubMed 39161275

  • Beer BN, Kellner C, Sundermeyer J, Besch L, Dettling A, Kirchhof P, Blankenberg S, Magnussen C, Schrage B. Prediction of cardiac worsening through to cardiogenic shock in patients with acute heart failure. ESC Heart Fail. 2024 Aug;11(4):2249-2258. doi: 10.1002/ehf2.14792. Epub 2024 Apr 17.

    PubMed 38632837

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Heart Failure and Decompensated Heart Failure, run by Universitätsklinikum Hamburg-Eppendorf 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 2 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?

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?

Contact Benedikt Schrage, MD, PhD (+49 40 7410 0, b.schrage@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to cardiovascular death or first rehospitalisation for heart failure (time frame: from enrolment up to 5 years). 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 NCT07508891, which also lists 3 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 2 Apr 2026.

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