Observational study on heart failure management in Italian outpatient clinics
Optimization of Therapy in the Italian Management of Heart Failure: OPTIMA-HF Observational Study
Federico II University · NCT06287164
This study looks at how heart failure patients in Italy are treated in outpatient clinics to see if educational programs can help them stick to their prescribed medications better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Federico II University (other) |
| Locations | 1 site (Napoli) |
| Trial ID | NCT06287164 on ClinicalTrials.gov |
What this trial studies
The OPTIMA-HF study is an observational, cross-sectional, multicenter study that aims to gather data on heart failure patients treated in various outpatient settings across Italy. It focuses on understanding the demographic characteristics and disease features of these patients, particularly regarding the prescription of guideline-directed medical therapy (GDMT). The study will assess improvements in therapy adherence following educational initiatives. Data collection will occur in heart failure outpatient clinics of Italian university hospitals and territorial cardiology services.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with stable heart failure conditions who are receiving outpatient care.
Not a fit: Patients with clinical conditions that could compromise their safety during the study may not benefit from participation.
Why it matters
Potential benefit: If successful, this study could enhance the management and treatment of heart failure patients in Italy, leading to better health outcomes.
How similar studies have performed: Other observational studies have shown success in similar approaches, indicating the potential for valuable insights into heart failure management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: age \>18 years, post-menopausal, permanent sterile, or childbearing potential on highly effective contraceptive methods women, stable clinical conditions (NYHA class I-III), outpatients setting, capability to understand the study procedures and sign the informed consent form. Exclusion Criteria: any clinical condition that would have jeopardized patient safety while participating in this study.
Where this trial is running
Napoli
- Federico II University of Naples, Department of Advanced Biomedical Sciences — Napoli, Italy (RECRUITING)
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