Clinical trial NCT06192524: OPTImal PHARMacological Therapy for Patients With Heart Failure: The OPTIPHARM-HF Registry
Official title: OPTImal PHARMacological Therapy for Patients With Heart Failure: The OPTIPHARM-HF Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Keywords: GDMT
HFrEF
HFpEF
Clinical Outcomes
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sponsor class: OTHER
Collaborators: name: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
name: Centro Cardiologico Monzino
name: A.O. Ospedale Papa Giovanni XXIII
name: IRCCS Ospedale San Raffaele
name: Azienda Ospedaliera Universitaria Senese
name: IRCCS Humanitas, Rozzano
name: Ospedale Policlinico San Martino
name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Fondazione IRCCS Policlinico San Matteo di Pavia
name: Ospedali Riuniti di Foggia
name: A.O.U. Città della Salute e della Scienza
name: ASU Giuliano Isontina, Trieste
name: Azienda Ospedaliera S. Maria della Misericordia
name: IRCCS Policlinico S. Donato
name: ASST Santi Paolo e Carlo
First posted: 2024-01-05
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: 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.
timeFrame: 1 year
Secondary outcomes:
measure: To evaluate sequence of introduction of recommended GDMT, medications' up titration, when needed, maintenance of evidence-based treatment during follow-up
timeFrame: 1 year
measure: To describe GDMT implementation, dosing, and sequencing in specific HF population including de novo HF, worsening HF, advanced HF and HF with improved EF
timeFrame: 1 year
measure: To assess cumulative rate of CV events and the impact on prognosis of GDMT and its doses.
timeFrame: 2 years
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: ASST Spedali Civili
Study officials:
affiliation: ASST Spedali Civili
name: Marco Metra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ASST Spedali Civili
name: Riccardo M. Inciardi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: