OPTImal PHARMacological Therapy for Patients With Heart Failure: The OPTIPHARM-HF Registry

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Status: Enrolling

Conditions: Heart Failure

Study type: Observational

Funder types: Other

Identifiers

NCT06192524

NP5441

Details and patient eligibility

About

Prospective, observational, multicenter, national study of adult patients with HF to assess prescription and adherence to evidence-based Guideline-Directed Medical Therapy (GDMT) in patients with Heart Failure (HF).

Full description

Prospective, observational, multicenter, national study designed to evaluate the care and outcomes of patients with HF, to understand reasons for lack of implementation of evidence-based treatment and the impact of adherence to treatment on clinical outcomes in patients with HF across the full spectrum of left ventricular ejection fraction (LVEF).

The study will enroll consecutive patients with symptomatic HF, aged ≥ 18 years from at least 30 Italian tertiary HF care centers. Both outpatients and in-patients with chronic and acute decompensated HF will be consecutively recruited. Patients will be followed for a maximum duration of 24 months.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.