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NCT Number: NCT06827314

Pharmacological and Mechanical Support Approaches in the Management of Acute Heart Failure in the Regional Network Model for the Management of Cardiogenic Shock

The goal of this observational study is to understand and describe the epidemiology of cardiogenic shock in Emilia Romagna with a specific focus on outcome stratified by aetiologies, sex and age. The main outcomes are:

* Incidence of cardiogenic shock (CS) over the total CICU admissions, CS-related in-hospital mortality and length of hospitalization, stratified by aetiologies, sex and age * Epidemiology of patients admitted with CS, regarding age, gender, etiology and modality of presentation (acute or acute on chronic), echocardiographic and haemodynamic data, treatment strategy with inotropes and/or short-term MCS, cardiac arrest.

This is an observational study without intervention. Patients will be treated according to current clinical practice, according to physician judgment and data sheets of each drug used according to clinical practice.

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Key information

Conditions

Cardiogenic Shock Acute Coronary Event 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

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Luciano Potena, MD

CONTACT

[email protected]

0512143725

About this study

This is a multicenter observational study with both a retrospective and a prospective cohort.

Study population will include all consecutive patients diagnosed with cardiogenic shock and admitted to the cardiac intensive care unit of the participating centers.

For the patients enrolled at IRCCS Azienda Ospedaliera-Universitaria di Bologna this study will involve a collaboration with UO Cardiologia.

For the retrospective cohort, patients will be selected based on ICD9 discharge codes and included if they fulfill inclusion criteria after review of hospital charts. The retrospective cohort will serve as a historical comparison regarding epidemiology, treatment strategies and survival.

Incidence and workload burden of CICU will be studied comparing the number of CS patients and the total number of admissions in the study period.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients (≥18 years old) admitted to a participating CICU with suspected CS of stage from C to E according to SCAI (Society of cardiovascular intervention)classification of cardiogenic shock.
  • Signed informed consent.

Exclusion criteria

  • CS following cardiac surgery (post-cardiotomy), ● Significant polytrauma or neurological injury.

Treatment and study plan

Primary outcomes

  1. Incidence of CS over the total CICU admissions stratified by aetiologies, sex and age.

    Time frame: 5 years

    Incidence

  2. Length of hospitalization, stratified by aetiologies, sex and age.

    Time frame: 5 years

    Days

  3. CS-related in-hospital mortality stratified by aetiologies, sex and age.

    Time frame: 5 years

    Incidence

  4. Epidemiology of patients admitted with CS, regarding age, gender, etiology and modality of presentation (acute or acute on chronic), echocardiographic and haemodynamic data, treatment strategy with inotropes and/or short-term MCS, cardiac arrest.

    Time frame: 5 years

    Demography description

  5. Recovery from cardiogenic shock, defined as improvement to at least SCAI stage B or discharge from CICU to a step-down ward

    Time frame: 5 years

    Recovery from cardiogenic shock

  6. In-hospital survival according to age, etiology, presentation (acute or acute on chronic) and modality of treatment (inotropes or MCS).

    Time frame: 5 years

    In-hospital survival

  7. Rate and reason of unplanned re-hospitalizations within one month after primary discharge

    Time frame: 5 years

    Rate and reason of unplanned re-hospitalizations

  8. Workload burden will be estimated as the percentage of CS admission and the mean duration of CICU stay as compared to other admissions during study period

    Time frame: 5 years

    Workload burden

  9. Rate of adherence to several items and differences between older era (retrospective data) and prospective cohort

    Time frame: 5 years

    Blood counts, ECG, oxygen saturation and respiratory monitoring.

Secondary outcomes

  1. Rate of successful bridge to heart replacement therapy (heart transplant or LVAD implant) in patients potentially eligible (i.e. age < 71 years old) and transferred to IRCCS Policlinico S.Orsola hub center.

    Time frame: 5 years

    Rate of successful bridge to heart replacement therapy

  2. Comparison of survival between patients who underwent HRT as a consequence of CS to elective patients in the study period

    Time frame: 5 years

    Comparison of survival

  3. Description of in-hospital complications such as rate of renal replacement therapy, number of nosocomial infections with therapy and consequent associated mortality.

    Time frame: 5 years

    Description of in-hospital complications

  4. Description of MCS-related complications, including bleeding requiring transfusions, vascular complications including bleeding requiring intervention and limb ischemia.

    Time frame: 5 years

    Description of MCS-related complications

Study contacts

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

Luciano Potena, MD

CONTACT

[email protected]

0512143725

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Feb 14, 2025
Registry last updated
Feb 14, 2025

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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