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.
Study Type
OBSERVATIONAL
Enrollment
1,000
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
RECRUITINGTime 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.
Time frame: from enrolment up to 5 years
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.
Time frame: from enrolment up to 5 years
Time to cardiovascular death
Cause of death adjudicated by local investigators. Time-to-event analysis.
Time frame: 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.
Time frame: 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.
Time frame: from enrolment up to 5 years
Incidence rate of progression of cardiogenic shock
Defined as progression to higher SCAI stage.
Time frame: 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.
Time frame: within index hospitalisation (enrolment to discharge or death)
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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.
Time frame: 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.
Time frame: 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.
Time frame: assessed at discharge from index hospitalisation