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

Recruiting

• Conditions: Cardiogenic Shock; Acute Coronary Event

• Registration Number: NCT06827314
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Timeline

• Study Start: 2022-12-06
• Status Verified: 2024-12
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-02-13
• Last Update Submitted: 2025-02-13
• Study First Posted: 2025-02-14
• Last Update Posted: 2025-02-14
• Primary Completion: 2027-11
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of CS over the total CICU admissions stratified by aetiologies, sex and age.	5 years	Incidence
Length of hospitalization, stratified by aetiologies, sex and age.	5 years	Days
CS-related in-hospital mortality stratified by aetiologies, sex and age.	5 years	Incidence
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.	5 years	Demography description
Recovery from cardiogenic shock, defined as improvement to at least SCAI stage B or discharge from CICU to a step-down ward	5 years	Recovery from cardiogenic shock
In-hospital survival according to age, etiology, presentation (acute or acute on chronic) and modality of treatment (inotropes or MCS).	5 years	In-hospital survival
Rate and reason of unplanned re-hospitalizations within one month after primary discharge	5 years	Rate and reason of unplanned re-hospitalizations
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	5 years	Workload burden
Rate of adherence to several items and differences between older era (retrospective data) and prospective cohort	5 years	Blood counts, ECG, oxygen saturation and respiratory monitoring.

Secondary Outcome Measures

Name	Time	Method
Description of MCS-related complications, including bleeding requiring transfusions, vascular complications including bleeding requiring intervention and limb ischemia.	5 years	Description of MCS-related complications
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.	5 years	Rate of successful bridge to heart replacement therapy
Comparison of survival between patients who underwent HRT as a consequence of CS to elective patients in the study period	5 years	Comparison of survival
Description of in-hospital complications such as rate of renal replacement therapy, number of nosocomial infections with therapy and consequent associated mortality.	5 years	Description of in-hospital complications

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy