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

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

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart failure free survival	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	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	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	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.	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

• 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

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): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: OPPORTUNITIES

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No