Improving drug management for heart failure patients
Drug Management in Heart Failure
IRCCS San Raffaele Roma · NCT06915584
This study is testing a new AI system to help doctors make sure heart failure patients are getting the right medications and care based on the latest guidelines.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 450 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS San Raffaele Roma (other) |
| Locations | 1 site (Rome, RM) |
| Trial ID | NCT06915584 on ClinicalTrials.gov |
What this trial studies
This study aims to create an interactive AI-based multicenter database to enhance the quality of care for patients with heart failure (HF). It will collect detailed information on patient characteristics, treatment practices, adherence to guideline-based optimal drug therapy, and outcomes. The database is built on a registry that has been active for two years and will utilize an AI algorithm to assess whether patients are receiving appropriate treatment according to the latest European Society of Cardiology guidelines. The study seeks to identify levels of non-adherence to these guidelines and provide insights to reduce medical inertia and improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with a known diagnosis of heart failure for more than six months and recent or ongoing hospitalization for heart failure exacerbation.
Not a fit: Patients with conditions that may interfere with the study or contraindicate participation, such as advanced COPD or concurrent neoplasia, may not benefit from this study.
Why it matters
Potential benefit: If successful, this initiative could significantly improve treatment adherence and outcomes for heart failure patients.
How similar studies have performed: Other studies have shown success with similar approaches in improving adherence to treatment guidelines in heart failure management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
Where this trial is running
Rome, RM
- IRCCs San Raffaele — Rome, RM, Italy (RECRUITING)
Study contacts
- Study coordinator: Lucia Gatta, PhD
- Email: lucia.gatta@sanraffaele.it
- Phone: +390652253440
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure, Descriptive appropriateness, Registry, Digital therapy