Multimodal Phenotyping In Patients Referred With Acute Cardiac faiLurE

NCT07515508 | Recruiting

• 1 other identifier: 24-1041_1-S1
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Cardiogenic Shock; Acute Heart Failure (AHF)

Outcome Measures

Primary Outcomes (1)

• Mortality

  30 days

Secondary Outcomes (3)

• Mortality

  6 and 12 months

• Rehospitalization for heart failure

  From hospital discharge until 12 months

• Rehospitalization for cardiac reasons (non-elective)

  From hospital discharge until 12 months

Other Outcomes (6)

• Bleeding ≥ SHARC 3a

  Index hospitalization

• Functional capacity (physical)

  At 6 months follow up

• Functional capacity (cognitive)

  At 6 months follow up

Study Arms (1)

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive adult patients hospitalized at participating study sites with acute heart failure and cardiogenic shock (SCAI stages B-E).

You may qualify if:

• Patients hospitalized with acute heart failure SCAI stage B - E.

You may not qualify if:

• Not capable of providing informed consent due to reasons not attributable to cardiogenic shock
• Cardiogenic shock following cardiothoracic surgery

Sponsors & Collaborators

• University Heart Center Freiburg - Bad Krozingen: lead

Study Sites (4)

University Heart Center Freiburg - Bad Krozingen

Bad Krozingen, 79189, Germany

RECRUITING

University Medical Center Freiburg, Interdisciplinary Medical Intensive Care

Freiburg im Breisgau, 79106, Germany

RECRUITING

Department for Internal Medicine 8, Clinic for Cardiology and Rhythmology, University Clinic of the Paracelsus Medi-cal University Nuremberg

Nuremberg, Germany

RECRUITING

Schwarzwald Baar Klinikum Villingen-Schwenningen, Klinik für Kardiologie und Intensivmedizin

Villingen-Schwenningen, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma (EDTA, citrate), PBMCs, buffy coat, urine

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Central Study Contacts

Lucas Bacmeister, MD

CONTACT

004976127034010; lucas.bacmeister@uniklinik-freiburg.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 7, 2026
• Study Start: August 7, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-07

Locations

DE (4)