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

Recruiting

• Conditions: Heart Failure

• Registration Number: NCT06192524
• Lead Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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.

Study Timeline

• Study Start: 2022-07-18
• Status Verified: 2023-12
• Study First Submitted: 2023-12-21
• Study First Submitted QC: 2023-12-21
• Last Update Submitted: 2023-12-21
• Study First Posted: 2024-01-05
• Last Update Posted: 2024-01-05
• Primary Completion: 2024-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	1 year	GDMT Prevalence and dosing

Secondary Outcome Measures

Name	Time	Method
To evaluate sequence of introduction of recommended GDMT, medications' up titration, when needed, maintenance of evidence-based treatment during follow-up	1 year	GDMT sequencing and up-titration
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	GDMT in specific HF population
To assess cumulative rate of CV events and the impact on prognosis of GDMT and its doses.	2 years	* All-cause death; * Cardiovascular death; * Unplanned hospitalization for HF (including recurrent events); * Unplanned outpatient facility visits for HF where patient is treated with IV therapy; * Heart transplantation or Ventricular Assist Device implantation; * Non-fatal Myocardial Infarction (MI); * Non-fatal stroke; * Atrial fibrillation events; * ICD shock or hospitalization for ventricular arrhythmia; * Hospitalization for acute kidney injury or other kidney disease event including dialysis or end-stage renal disease defined as eGFR \< 15 mL/min/1.73 m2 or the need for renal replacement therapy.

Trial Locations

Locations (1)

ASST Spedali Civili; 🇮🇹 Brescia, Italy