Characterisation of phenotYpes in aCute Heart faiLure patiEnts
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Heart Failure, Decompensated Heart Failure, Cardiogenic Shock. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Primary outcome measures
- Time to cardiovascular death or first rehospitalisation for heart failure [Time frame: from enrolment up to 5 years]
Secondary outcome measures (9)
- Incidence rate of cardiovascular death and total rehospitalisations for heart failure [Time frame: from enrolment up to 5 years]
- Time to cardiovascular death [Time frame: from enrolment up to 5 years]
- Time to first rehospitalisation for heart failure [Time frame: from enrolment up to 5 years]
- Incidence rate of total rehospitalisations for heart failure [Time frame: from enrolment up to 5 years]
- Incidence rate of progression of cardiogenic shock [Time frame: 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)]
- Incidence rate of new onset of long-term renal replacement therapy [Time frame: 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)]
- Incidence rate of hypoxic brain injury diagnosis [Time frame: assessed at discharge from index hospitalisation]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- University Medical Center Hamburg-Eppendorf — Hamburg
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. PMID 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. PMID 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. PMID 38632837
Identifiers
NCT: NCT07508891 · CYCLE