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

Conditions

Heart Failure

Keywords

GDMT, HFrEF, HFpEF, Clinical Outcomes

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.

Inciardi RM, Volterrani M, Savarese G, Vaduganathan M, Oriecuia C, Lombardi CM, Gussago C, Agostoni P, Ameri P, Armentaro G, Arzilli C, Aspromonte N, Attanasio A, Badagliacca R, Barbieri L, Bocchino PP, Bursi F, Cameli M, Canonero M, Campodonico JS, Capovilla T, Carluccio E, Carugo S, Castiglione V, Catapano D, Cipriani M, Correale M, D'Amario D, De Caterina R, De Ferrari GM, D'Elia E, Di Odoardo L, Emdin M, Falco L, Ferrante G, Fornaro A, Fornaro P, Guastamiglio G, Guazzi M, Iacoviello M, Imazio M, Incaminato E, La Rovere MT, Leonardi S, Maccallini M, Mandoli GE, Masarone D, Masetti M, Mazzoni A, Mazzotta M, Merlo M, Moschini L, Novarese F, Palazzuoli A, Pastore MC, Patti G, Pedretti RFE, Pidello S, Piepoli MF, Pinto G, Potena L, Raineri C, Rubbo FM, Sabatino M, Salzano A, Sciacqua A, Senni M, Severino P, Sinagra G, Sposato B, Taddei S, Valleggi A, Vignati C, Vizza D, Specchia C, Rosano G, Metra M, OPTIPHARM‐HF investigators.

2025-12-17

10.1002/ejhf.70074

OPTImal PHARMacological Therapy for Patients with Heart Failure: Rationale and Design of the OPTIPHARM-HF Registry

Riccardo M. Inciardi, Muthiah Vaduganathan, Carlo Lombardi, Cristina Gussago, Piergiuseppe Agostoni et al. (42 authors)

European Journal of Heart Failure2024-06-236 citations

10.1002/ejhf.3260

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Italy

Contacts

Primary ContactCristina Gussago

studiclinici.brescia@gmail.com030 3996927

Outcome results