Characterisation of phenotYpes in aCute Heart faiLure patiEnts (CYCLE)

March 30, 2026 updated by: Universitätsklinikum Hamburg-Eppendorf
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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Benedikt Schrage, MD, PhD
  • Phone Number: +49 40 7410 0
  • Email: b.schrage@uke.de

Study Contact Backup

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • Recruiting
        • University Medical Center Hamburg-Eppendorf
        • Contact:
        • Contact:
          • Benedikt N Schrage, MD, PhD
          • Phone Number: +49 40 7410 0
          • Email: b.schrage@uke.de

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Age < 18 years
  • No written informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to cardiovascular death or first rehospitalisation for heart failure
Time Frame: from enrolment up to 5 years
Etiologies of death and hospitalisation will be adjudicated by local investigators. Time-to-event analyses are planned for the primary outcome.
from enrolment up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence rate of cardiovascular death and total rehospitalisations for heart failure
Time Frame: from enrolment up to 5 years
Etiologies will be adjudicated by local investigators. Repeated event analyses are planned for this secondary outcome.
from enrolment up to 5 years
Time to cardiovascular death
Time Frame: from enrolment up to 5 years
Cause of death adjudicated by local investigators. Time-to-event analysis.
from enrolment up to 5 years
Time to first rehospitalisation for heart failure
Time Frame: from enrolment up to 5 years
Etiologies will be adjudicated by local investigators. Time-to-event analyses are planned.
from enrolment up to 5 years
Incidence rate of total rehospitalisations for heart failure
Time Frame: from enrolment up to 5 years
Etiologies will be adjudicated by local investigators. Repeated event analyses are planned.
from enrolment up to 5 years
Incidence rate of progression of cardiogenic shock
Time Frame: within index hospitalisation (enrolment to discharge or death)
Defined as progression to higher SCAI stage.
within index hospitalisation (enrolment to discharge or death)
Incidence rate of total severe bleeding events
Time Frame: within index hospitalisation (enrolment to discharge or death)
Defined as BARC 3-5. Repeated event analyses are planned.
within index hospitalisation (enrolment to discharge or death)
Incidence rate of new onset of long-term renal replacement therapy
Time Frame: within index hospitalisation (enrolment to discharge or death)
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.
within index hospitalisation (enrolment to discharge or death)
Incidence rate of total severe peripheral or abdominal ischaemia events
Time Frame: within index hospitalisation (enrolment to discharge or death)
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.
within index hospitalisation (enrolment to discharge or death)
Incidence rate of hypoxic brain injury diagnosis
Time Frame: assessed at discharge from index hospitalisation
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.
assessed at discharge from index hospitalisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

December 30, 2025

First Submitted That Met QC Criteria

March 30, 2026

First Posted (Actual)

April 2, 2026

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CYCLE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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