Evaluating Heart Failure Treatment and Outcomes
OPTImal PHARMacological Therapy for Patients With Heart Failure: The OPTIPHARM-HF Registry
This study is trying to see how well heart failure patients follow their prescribed treatments and how that affects their health over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Academic / other |
| Locations | 1 site (Brescia) |
| Trial ID | NCT06192524 on ClinicalTrials.gov |
What this trial studies
This is a prospective, observational, multicenter study that aims to assess the prescription and adherence to evidence-based Guideline-Directed Medical Therapy (GDMT) in adult patients with heart failure (HF). The study will enroll patients aged 18 and older from at least 30 Italian tertiary HF care centers, including both outpatients and in-patients with chronic and acute decompensated HF. Participants will be followed for up to 24 months to understand the reasons for the lack of implementation of evidence-based treatments and the impact of adherence on clinical outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with chronic or acute decompensated heart failure who are receiving at least one medication for heart failure management.
Not a fit: Patients with a life expectancy of less than one year due to non-cardiac causes or those who have previously undergone heart transplant or left ventricular assist device implantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management and outcomes of patients with heart failure by identifying barriers to effective treatment.
How similar studies have performed: Other studies focusing on adherence to guideline-directed therapies in heart failure have shown promising results, indicating that this approach is both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients ≥ 18 years old * Signed patient informed consent form (ICF) * Diagnosis of chronic or acute decompensated HF according to ESC guidelines and the universal definition of HF. * Receiving at least one drug for management of HF at study enrollment (including diuretics, β-blockers, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, aldosterone antagonists). Exclusion Criteria: * Planned participation or participation in a clinical trial; * Life expectancy \< 1 year because of non-cardiac causes; * Previous heart transplant or left ventricular assist device implantation.
Where this trial is running
Brescia
- ASST Spedali Civili — Brescia, Italy (Recruiting)
Study contacts
- Principal investigator: Marco Metra, MD — ASST Spedali Civili
- Study coordinator: Cristina Gussago
- Email: studiclinici.brescia@gmail.com
- Phone: 030 3996927
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.