Multimodal Phenotyping In Patients Referred With Acute Cardiac faiLurE
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Heart Center Freiburg - Bad Krozingen
About this trial
The goal of this observational study is to learn whether information collected during routine hospital care, together with blood and urine samples, can help doctors better identify different types of cardiogenic shock and better predict outcomes in adults hospitalized with acute heart failure and cardiogenic shock. The main question is whether clinical findings, imaging results, and biomarkers, including sex-specific factors, are associated with the risk of death within 30 days. Participants will not receive an experimental treatment. Researchers will collect data from routine care, collect additional blood and urine samples for biobanking, and follow participants after hospital discharge
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients hospitalized with acute heart failure SCAI stage B - E.
Disqualifiers
Not capable of providing informed consent due to reasons not attributable to cardiogenic shock
Cardiogenic shock following cardiothoracic surgery
Trial population
Consecutive adult patients hospitalized at participating study sites with acute heart failure and cardiogenic shock (SCAI stages B-E).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
600 Participants
are grouped into 1 trial groupGroup A: Arm 1
Trial outcomes
Primary outcomes
1
Mortality
Time frame
30 daysSecondary outcomes
1
Mortality
Time frame
6 and 12 months2
Rehospitalization for heart failure
Time frame
From hospital discharge until 12 months3
Rehospitalization for cardiac reasons (non-elective)
Time frame
From hospital discharge until 12 monthsOther outcomes
1
Bleeding ≥ SHARC 3a
Time frame
Index hospitalization2
Functional capacity (physical)
Six-minute walk test
Time frame
At 6 months follow up3
Functional capacity (cognitive)
MOCA
Time frame
At 6 months follow up4
Functional capacity
KCCQ
Time frame
At 6 months follow upSponsors and contacts
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Source ClinicalTrials.gov