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

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).

Study Overview

• Status: Recruiting
• Conditions: Heart Failure

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 Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Cristina Gussago; Phone Number: 030 3996927; Email: studiclinici.brescia@gmail.com

Study Locations

• Italy
  • Brescia, Italy, 25123
    • Recruiting
    • ASST Spedali Civili
    • Contact: Cristina Gussago; Phone Number: 030 3996927; Email: studiclinici.brescia@gmail.com
    • Principal Investigator: Riccardo M. Inciardi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Consecutive patients with symptomatic HF. Both outpatients and in-patients with chronic and acute decompensated HF will be consecutively recruited.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	GDMT Prevalence and dosing	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate sequence of introduction of recommended GDMT, medications' up titration, when needed, maintenance of evidence-based treatment during follow-up	GDMT sequencing and up-titration	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	GDMT in specific HF population	1 year
To assess cumulative rate of CV events and the impact on prognosis of GDMT and its doses.	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.	2 years

Collaborators and Investigators

• Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
• Collaborators: Azienda Ospedaliera Città della Salute e della Scienza di Torino; IRCCS Policlinico S. Donato; Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico; Azienda Ospedaliera Universitaria Senese; Azienda Ospedaliera S. Maria della Misericordia; Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy; ASST Santi Paolo e Carlo; A.O. Ospedale Papa Giovanni XXIII; Centro Cardiologico Monzino; Ospedale Policlinico San Martino; Fondazione IRCCS Policlinico San Matteo di Pavia; Ospedali Riuniti di Foggia; IRCCS Ospedale San Raffaele; IRCCS Humanitas, Rozzano; ASU Giuliano Isontina, Trieste
• Investigators: Principal Investigator: Marco Metra, MD, ASST Spedali Civili; Principal Investigator: Riccardo M. Inciardi, MD, PhD, ASST Spedali Civili

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2022
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: December 21, 2023
• First Submitted That Met QC Criteria: December 21, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: HFrEF; HFpEF; Clinical Outcomes; GDMT
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: NP5441

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO