Clinical trial NCT06827314: Pharmacological and Mechanical Support Approaches in the Management of Acute Heart Failure in the Regional Network Model for the Management of Cardiogenic Shock
Official title: Pharmacological and Mechanical Support Approaches in the Management of Acute Heart Failure in the Regional Network Model for the Management of Cardiogenic Shock
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiogenic Shock
Acute Coronary Event
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For the prospective cohort, study population consists of all consecutive patients diagnosed with CS and admitted to participating CICUs in the Emilia Romagna region. For the prospective cohort patients will be enrolled after study approval and until 31 December 2027.

Patients will be enrolled upon admission or at the development of CS if already admitted.

Retrospective data will be collected for five years, starting from January 1st 2018 until the starting date of the study.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of CS over the total CICU admissions stratified by aetiologies, sex and age.
timeFrame: 5 years
measure: Length of hospitalization, stratified by aetiologies, sex and age.
timeFrame: 5 years
measure: CS-related in-hospital mortality stratified by aetiologies, sex and age.
timeFrame: 5 years
measure: 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.
timeFrame: 5 years
measure: Recovery from cardiogenic shock, defined as improvement to at least SCAI stage B or discharge from CICU to a step-down ward
timeFrame: 5 years
measure: In-hospital survival according to age, etiology, presentation (acute or acute on chronic) and modality of treatment (inotropes or MCS).
timeFrame: 5 years
measure: Rate and reason of unplanned re-hospitalizations within one month after primary discharge
timeFrame: 5 years
measure: 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
timeFrame: 5 years
measure: Rate of adherence to several items and differences between older era (retrospective data) and prospective cohort
timeFrame: 5 years
Secondary outcomes:
measure: 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.
timeFrame: 5 years
measure: Comparison of survival between patients who underwent HRT as a consequence of CS to elective patients in the study period
timeFrame: 5 years
measure: Description of in-hospital complications such as rate of renal replacement therapy, number of nosocomial infections with therapy and consequent associated mortality.
timeFrame: 5 years
measure: Description of MCS-related complications, including bleeding requiring transfusions, vascular complications including bleeding requiring intervention and limb ischemia.
timeFrame: 5 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Luciano G Potena, MD
role: PRINCIPAL_INVESTIGATOR
References: