Drug Management in Heart Failure

NCT06915584 | Recruiting

• 1 other identifier: 162/SR/24
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the proposal is to create an interactive AI-based multicentre prospective database to provide information on how to improve the QoC for pts with HF.This will provide detailed information on pts characteristics,treatment practices, adherence to prescribed guideline-based optimal drug therapy,and outcomes.The database stems from a registry started two years ago,conceived to provide a contemporary snapshot on the adherence to the latest European GGLL for the therapeutic management of pts with HF.The database will be integrated with a specifically designed algorithm that provides an accurate feedback on whether patients are properly treated according to the ESC most recent recommendations.The expected outcomes are:-define non-adherence level to GGLL-based recommendations for treatment of HF;-provide information on initiation, adherence and persistence over time of the recommended treatment;-reduce medical inertia;produce practical implications to reduce morbidity and mortality

Conditions

Heart Failure

Keywords

Heart Failure; Descriptive appropriateness; Registry; Digital therapy

Outcome Measures

Primary Outcomes (1)

• create a registry that provides an updated assessment of the pattern of use of treatments recommended by guidelines in order to collect new evidence on compliance with them. Be they European or Italian for the treatment of patients with increased cardiov

  from enrollment to the end of observation al 24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with heart Failure

You may qualify if:

• Both gender
• Age \>18 years
• Signed informed consent for the study
• Known diagnosis of heart failure \> 6 months
• Recent or ongoing hospitalization for heart failure exacerbation

You may not qualify if:

• Conditions that, in the investigator's judgment, may interfere with the study or contraindicate participation for safety reasons
• Concurrent diagnosis of neoplasia
• Advanced COPD (FEV1 \<50%)
• Advanced valvular heart disease (severe mitral-aortic stenosis-insufficiency requiring cardiac surgery)

Sponsors & Collaborators

• IRCCS San Raffaele Roma: lead
• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari: collaborator
• Azienda Ospedaliera Universitaria Mater Domini, Catanzaro: collaborator

Study Sites (1)

IRCCs San Raffaele

Rome, RM, 00166, Italy

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Lucia Gatta, PhD

CONTACT

+390652253440; lucia.gatta@sanraffaele.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 8, 2025
• Study Start: November 30, 2024
• Primary Completion: June 30, 2025
• Study Completion: August 31, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-03

Locations

IT (1)