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OpenTrials
Completed

NCT Number: NCT07473063

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Asst Papa Giovanni Xxiii - Dip. Di Cardiologia

Bergamo, 24127, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2023
Study completion
2024
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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