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

Heart Failure Clinical Trial

— OPTIPHARM-HF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06192524
• Other study ID #: NP5441
• Status: Recruiting
• Start date: July 18, 2022
• Est. completion date: October 1, 2025

Study information

• Verified date: December 2023
• Source: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
• Contact: Cristina Gussago
• Phone: 030 3996927
• Email: studiclinici.brescia[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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, ß-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.

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Italy	ASST Spedali Civili	Brescia

Sponsors (16)

Lead Sponsor

Collaborator

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

A.O. Ospedale Papa Giovanni XXIII, ASST Santi Paolo e Carlo, ASU Giuliano Isontina, Trieste, Azienda Ospedaliera Città della Salute e della Scienza di Torino, Azienda Ospedaliera S. Maria della Misericordia, Azienda Ospedaliera Universitaria Senese, Centro Cardiologico Monzino, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Fondazione IRCCS Policlinico San Matteo di Pavia, IRCCS Humanitas, Rozzano, IRCCS Ospedale San Raffaele, IRCCS Policlinico S. Donato, Ospedale Policlinico San Martino, Ospedali Riuniti di Foggia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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