Acute Heart Failure, Cardiogenic Shock, Decompensated Heart Failure
Conditions
Keywords
cardiogenic shock, acute heart failure, heart failure, biomarker, biobank, cohort study, phenotyping, risk prediction
Brief summary
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.
Interventions
None listed
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to cardiovascular death or first rehospitalisation for heart failure | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of cardiovascular death and total rehospitalisations for heart failure | from enrolment up to 5 years | Etiologies will be adjudicated by local investigators. Repeated event analyses are planned for this secondary outcome. |
| Time to cardiovascular death | from enrolment up to 5 years | Cause of death adjudicated by local investigators. Time-to-event analysis. |
| Time to first rehospitalisation for heart failure | from enrolment up to 5 years | Etiologies will be adjudicated by local investigators. Time-to-event analyses are planned. |
| Incidence rate of total rehospitalisations for heart failure | from enrolment up to 5 years | Etiologies will be adjudicated by local investigators. Repeated event analyses are planned. |
| Incidence rate of progression of cardiogenic shock | within index hospitalisation (enrolment to discharge or death) | Defined as progression to higher SCAI stage. |
| Incidence rate of total severe bleeding events | within index hospitalisation (enrolment to discharge or death) | Defined as BARC 3-5. Repeated event analyses are planned. |
| Incidence rate of new onset of long-term renal replacement therapy | 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. |
| Incidence rate of total severe peripheral or abdominal ischaemia events | 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. |
| Incidence rate of hypoxic brain injury diagnosis | 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. |
Countries
Germany
Contacts
CONTACTBenedikt Schrage, MD, PhD
CONTACTChristina Magnussen, MD
Outcome results
None listed