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NCT Number: NCT07508891

Characterisation of phenotYpes in aCute Heart faiLure patiEnts

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.

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Key information

Conditions

Acute Heart Failure Cardiogenic Shock Cardiovascular Diseases Decompensated Heart Failure Heart Diseases Heart Failure Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Cardiogenic Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Time to cardiovascular death

    Time frame: from enrolment up to 5 years

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

  3. 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.

  4. 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.

  5. Incidence rate of progression of cardiogenic shock

    Time frame: within index hospitalisation (enrolment to discharge or death)

    Defined as progression to higher SCAI stage.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Benedikt Schrage, MD, PhD

CONTACT

[email protected]

+49 40 7410 0

Christina Magnussen, MD

CONTACT

[email protected]

+49 40 7410 0

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Acronym: CYCLE

Important dates

Study start
2019
Primary completion
2030
Study completion
2030
First posted
Apr 2, 2026
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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