Optimization of Heart Failure Treatment and Implementation of a Risk-based Patient Care Model.

March 10, 2026 updated by: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

Optimization of Treatment in Patients With a Diagnosis of Heart Failure and Realization of a Care Model Based on Risk Stratification

Collection of data from patients with heart failure, both in the acute phase (data collection during hospital admission) and in the chronic phase (data collection during outpatient follow-up), optimization of the treatment of patients with heart failure, and implementation of a care model based on risk stratification.

Study Overview

Status

Completed

Conditions

Heart Failure

Detailed Description

The study is structured into two distinct phases: retrospective and prospective.

The retrospective phase aims to collect anamnestic, clinical, instrumental, and treatment data relating to patients diagnosed with heart failure, both at discharge (acute heart failure) and in the outpatient setting (chronic heart failure), referred to the Cardiovascular Department of ASST Papa Giovanni XXIII in Bergamo during the period from January 1, 2017 to May 31, 2020.

The same data relating to patients diagnosed with heart failure, both at discharge (acute heart failure) and in the outpatient setting (chronic heart failure), referred to the Cardiovascular Department of ASST Papa Giovanni XXIII will be collected prospectively over a three-year period (from June 1, 2020 to June 30, 2023). Each patient will be followed for one year from the index date of inclusion in the study.

Study Type

Observational

Enrollment (Actual)

2428

Contacts and Locations

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

Study Locations

Italy
- - Bergamo, Italy, 24127
    - Asst Papa Giovanni Xxiii - Dip. Di Cardiologia

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

Probability Sample

Study Population

Patients with diagnosis of heart failure.

Description

Inclusion Criteria:

Patients consecutively referred to the Cardiovascular Department with a diagnosis of acute heart failure between January 1, 2017 and May 31, 2020 and between June 1, 2020 and June 30, 2023.

Exclusion Criteria:

None

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
Heart failure free survival Time Frame: Follow up at 3 months, 6 months and 12 months	Risk of adverse clinical events (mortality and morbidity) in the short to medium term.	Follow up at 3 months, 6 months and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of 3C-HF prognostic score Time Frame: Follow up at 3 months	Improvement of 3C-HF prognostic score in its predictive power for 90-day events (mortality and morbidity) by adding parameters from previously unexplored domains (e.g., biomarkers, frailty indices).	Follow up at 3 months
3C-HF score for heart failure free survival Time Frame: Follow up at 12 months	The prediction of the power of the 3C-HF score for long-term events (mortality and morbidity) over one year.	Follow up at 12 months
Implement a transitional care model Time Frame: Up to baseline	The treatment of patients hospitalized for acute decompensation of heart failure and, at discharge, implement a transitional care model that takes into account the individual patient's clinical characteristics.	Up to baseline
Prevent episodes of heart failure worsening. Time Frame: Up to baseline	Treatment of outpatients based on their individual risk profile for adverse clinical events, aiming to prevent episodes of heart failure worsening.	Up to baseline

Collaborators and Investigators

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

Sponsor

FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

Investigators

Study Chair: Antonello Gavazzi, MD, FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

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)

January 1, 2017

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

February 20, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)