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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07473063

Enrollment

2428

Registered

2026-03-16

Start date

2017-01-01

Completion date

2024-06-30

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Brief summary

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Improvement of 3C-HF prognostic score	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).
3C-HF score for heart failure free survival	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.
Implement a transitional care model	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.
Prevent episodes of heart failure worsening.	Up to baseline	Treatment of outpatients based on their individual risk profile for adverse clinical events, aiming to prevent episodes of heart failure worsening.

Countries

Italy

Contacts

STUDY_CHAIRAntonello Gavazzi, MD

FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

Outcome results