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CompletedNCT07473063Updated Mar 16, 2026

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

An observational study in Heart Failure, sponsored by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS. Completed at 1 site in Italy. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-03-16.

Sponsored by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
2,428
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Heart Failure

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03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 2,428 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.

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Lead sponsor

FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS is the lead sponsor of 20 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with diagnosis of heart failure.

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

Exclusion Criteria:

  • None
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
2,428 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Heart failure free survival

    Risk of adverse clinical events (mortality and morbidity) in the short to medium term.

    Time frame: Follow up at 3 months, 6 months and 12 months

Secondary outcomes

  1. 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).

    Time frame: Follow up at 3 months

  2. 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.

    Time frame: Follow up at 12 months

  3. 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.

    Time frame: Up to baseline

  4. 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.

    Time frame: Up to baseline

07

Study locations

1 site
  • Asst Papa Giovanni Xxiii - Dip. Di Cardiologia
    Bergamo, 24127, Italy
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07473063
Lead sponsor
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Responsible party
Sponsor
First posted
Mar 16, 2026
Start date
Jan 1, 2017
Primary completion
Jun 30, 2023
Completion
Jun 30, 2024
Last update
Mar 16, 2026

Study contacts

Antonello Gavazzi, MD
study chair · FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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