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

February 13, 2025 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Luciano Potena, MD
Phone Number: 0512143725
Email: scompenso.trapiantocuore@aosp.bo.it

Study Locations

Italy
- - Bologna, Italy, 40138
    - Recruiting
    - IRCCS Azienda Ospedaliero-Universitaria di Bologna
    - Contact:
      
      Luciano Potena, MD
      
      Phone Number: 0512143725
      
      Email: scompenso.trapiantocuore@aosp.bo.it

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of CS over the total CICU admissions stratified by aetiologies, sex and age. Time Frame: 5 years	Incidence	5 years
Length of hospitalization, stratified by aetiologies, sex and age. Time Frame: 5 years	Days	5 years
CS-related in-hospital mortality stratified by aetiologies, sex and age. Time Frame: 5 years	Incidence	5 years
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 years
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	5 years
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	5 years
Rate and reason of unplanned re-hospitalizations within one month after primary discharge Time Frame: 5 years	Rate and reason of unplanned re-hospitalizations	5 years
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	5 years
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.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 years
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	5 years
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	5 years
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	5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

Principal Investigator: Luciano G Potena, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2022

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

February 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)