OPTImal PHARMacological Therapy for Patients With Heart Failure: The OPTIPHARM-HF Registry
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Enrollment
- 2000
- Locations
- 1
- Primary Endpoint
- To describe the prevalence of use of GDMT, both as drugs administered and their dosing, defined according to target guidelines recommended doses, across the full spectrum of EF.
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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).
Detailed 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.
Investigators
Marco METRA
Marco Metra
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Eligibility 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.
Outcomes
Primary Outcomes
To describe the prevalence of use of GDMT, both as drugs administered and their dosing, defined according to target guidelines recommended doses, across the full spectrum of EF.
Time Frame: 1 year
GDMT Prevalence and dosing
Secondary Outcomes
- To evaluate sequence of introduction of recommended GDMT, medications' up titration, when needed, maintenance of evidence-based treatment during follow-up(1 year)
- To describe GDMT implementation, dosing, and sequencing in specific HF population including de novo HF, worsening HF, advanced HF and HF with improved EF(1 year)
- To assess cumulative rate of CV events and the impact on prognosis of GDMT and its doses.(2 years)