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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | from enrolment up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from enrolment up to 5 years |
| Time to cardiovascular death |
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Inclusion Criteria:
Exclusion Criteria:
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Hospitalised patients with acute heart failure of any aetiology and stage at a German tertiary care centre.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Hamburg-Eppendorf | Recruiting | Hamburg | 20246 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41342526 | Result | 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. | |
| 39161275 |
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| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Cause of death adjudicated by local investigators. Time-to-event analysis. |
| from enrolment up to 5 years |
| Time to first rehospitalisation for heart failure | 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 | 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 | Defined as progression to higher SCAI stage. | within index hospitalisation (enrolment to discharge or death) |
| Incidence rate of total severe bleeding events | 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 | 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 | 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 | 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 |
| 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. |
| 38632837 | Result | 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. |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |