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NCT Number: NCT07515508

Multimodal Phenotyping In Patients Referred With Acute Cardiac faiLurE

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

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Key information

Conditions

Cardiogenic Shock Acute Heart Failure (AHF) Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Cardiogenic Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Heart Center Freiburg - Bad Krozingen, Bad Krozingen, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Mortality

    Time frame: 30 days

Secondary outcomes

  1. Mortality

    Time frame: 6 and 12 months

  2. Rehospitalization for heart failure

    Time frame: From hospital discharge until 12 months

  3. Rehospitalization for cardiac reasons (non-elective)

    Time frame: From hospital discharge until 12 months

Other outcomes

  1. Bleeding ≥ SHARC 3a

    Time frame: Index hospitalization

  2. Functional capacity (physical)

    Time frame: At 6 months follow up

    Six-minute walk test

  3. Functional capacity (cognitive)

    Time frame: At 6 months follow up

    MOCA

  4. Functional capacity

    Time frame: At 6 months follow up

    KCCQ

  5. Quality of life measure

    Time frame: At 6 months follow up

    PHQ-2

  6. Quality of life measure

    Time frame: At 6 months follow up

    EQ-5D-5L

Study contacts

Contact information is provided by the study sponsor or research team.

Lucas Bacmeister, MD

CONTACT

[email protected]

004976127034010

Sponsors and collaborators

Lead sponsor

University Heart Center Freiburg - Bad Krozingen

Other

Registry information

Acronym: MIRACLE

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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