OPTImal PHARMacological therapy for patients with heart failure: Rationale and design of the OPTIPHARM‐HF registry

Author:

Inciardi Riccardo M.1,Vaduganathan Muthiah2,Lombardi Carlo M.1,Gussago Cristina1,Agostoni Piergiuseppe34,Ameri Pietro56,Aspromonte Nadia78,Calò Leonardo9,Cameli Matteo10,Carluccio Erberto11,Carugo Stefano12,Cipriani Manlio13,De Caterina Raffaele1415,De Ferrari Gaetano M.1617,Emdin Michele1819,Fornaro Alessandra20,Guazzi Marco2122,Iacoviello Massimo2324,Imazio Massimo25,La Rovere Maria Teresa26,Leonardi Sergio2728,Maccallini Marta2930,Masarone Daniele31,Moschini Luigi32,Palazzuoli Alberto33,Patti Giuseppe3435,Pedretti Roberto F.E.3637,Perrone Filardi Pasquale38,Piepoli Massimo F.3940,Potena Luciano41,Salzano Andrea42,Sciacqua Angela43,Senni Michele44,Sinagra Gianfranco45,Specchia Claudia46,Taddei Stefano47,Vizza Dario48,Savarese Gianluigi49,Rosano Giuseppe505152,Volterrani Maurizio5354,Metra Marco1,

Affiliation:

1. Institute of Cardiology, ASST Spedali Civili, Department of Medical and Surgical Specialties Radiological Sciences and Public Health, University of Brescia Brescia Italy

2. Cardiovascular Division, Brigham and Women's Hospital Boston Massachusetts USA

3. Centro Cardiologico Monzino, IRCCS Milan Italy

4. Department of Clinical Sciences and Community Health University of Milan Milan Italy

5. Cardiology Unit, IRCCS Ospedale Policlinico San Martino Genoa Italy

6. Department of Internal Medicine University of Genoa Genoa Italy

7. Department of Cardiovascular ad Thoracic Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS Rome Italy

8. Department of Cardiovascular and Pulmonary Sciences Catholic University of the Sacred Heart Rome Italy

9. Division of Cardiology, Policlinico Casilino Rome Italy

10. Department of Medical Biotechnologies, Division of Cardiology University of Siena Siena Italy

11. Cardiology and Cardiovascular Pathophysiology, Santa Maria della Misericordia Hospital, University of Perugia Perugia Italy

12. Department of Cardio‐Thoracic‐Vascular Diseases, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico and Department of Clinical Sciences and Community Health University of Milan Milan Italy

13. Clinical Cardiology and Heart Failure Unit, Mediterranean Institute for Transplantation and Advanced Specialized Therapies ISMETT Palermo Italy

14. Cardiology Division, Cardiothoracic and Vascular Department Pisa University Hospital Pisa Italy

15. Department of Surgical, Medical and Molecular Pathology and of Critical Sciences University of Pisa Pisa Italy

16. Division of Cardiology, Cardiovascular and Thoracic Department, Città della Salute e della Scienza Hospital Turin Italy

17. Department of Medical Sciences University of Turin Turin Italy

18. Cardiology Division, Fondazione Toscana Gabriele Monasterio Pisa Italy

19. Interdisciplinary Center for Health Sciences, Scuola Superiore Sant'Anna Pisa Italy

20. Cardiology Unit, Careggi University Hospital Florence Italy

21. Cardiology Division, San Paolo Hospital Milan Italy

22. Department of Biological Sciences University of Milan School of Medicine Milan Italy

23. Cardiology Unit, University Hospital Policlinico Riuniti Foggia Italy

24. Department of Medical and Surgical Sciences University of Foggia Foggia Italy

25. Department of Medicine (DMED), University of Udine, and Cardiothoracic Department University Hospital Santa Maria della Misericordia, ASUFC Udine Italy

26. Department of Cardiology Istituti Clinici Scientifici Maugeri IRCCS Montescano Italy

27. Division of Cardiology, Fondazione IRCCS Policlinico San Matteo Pavia Italy

28. Department of Molecular Medicine University of Pavia Pavia Italy

29. Humanitas Clinical and Research Hospital IRCCS Milan Italy

30. Department of Biomedical Sciences Humanitas University Milan Italy

31. Heart Failure Unit, Department of Cardiology AORN dei Colli‐Monaldi Hospital Naples Italy

32. Division of Cardiology Ospedale Oglio Po, ASST Cremona Cremona Italy

33. Cardiovascular Diseases Unit, Cardiothoracic and Vascular Department Le Scotte Hospital, University of Siena Siena Italy

34. Division of Cardiology, AOU Maggiore della Carità Novara Italy

35. Department of Translational Medicine, Università del Piemonte Orientale Novara Italy

36. Unit of Cardiology, Cardiovascular Department IRCCS MultiMedica, Sesto San Giovanni Milan Italy

37. University of Milano – Bicocca School of Medicine and Surgery Milan Italy

38. Department of Advanced Biomedical Sciences Federico II University of Naples Naples Italy

39. Clinical Cardiology, IRCCS Policlinicco San Donato, San Donato Milanese Milan Italy

40. Department of Biomedical Science for Health University of Milan Milan Italy

41. Heart Failure and Transplant Unit, IRCCS Azienda Ospedaliero Universitaria di Bologna Bologna Italy

42. Cardiology Unit, AORN Antonio Cardarelli Naples Italy

43. Geriatrics Division. AOU R.Dulbecco, Department of Medical and Surgical Sciences University Magna Graecia of Catanzaro Catanzaro Italy

44. Cardiology Unit, Cardiovascular Department, ASST Papa Giovanni XXIII Bergamo Italy

45. Cardiothoracovascular Department, Azienda Sanitaria Universitaria Giuliano Isontina, University of Trieste Trieste Italy

46. Department of Molecular and Translational Medicine University of Brescia Brescia Italy

47. Department of Clinical and Experimental Medicine University of Pisa Pisa Italy

48. Department of Clinical Internal, Anesthesiological and Cardiovascular Sciences Sapienza University of Rome, Policlinico Umberto I Rome Italy

49. Division of Cardiology, Department of Medicine Karolinska Institutet, and Heart and Vascular and Neuro Theme, Karolinska University Hospital Stockholm Sweden

50. Chair of Pharmacology University San Raffaele Rome Italy

51. Cardiology San Raffaele Cassino Hospital Cassino Italy

52. Cardiovascular CAG St George's University Hospital London UK

53. Department of Exercise Science and Medicine San Raffaele Open University of Rome Italy

54. Cardiopulmonary Department IRCCS San Raffaele Roma Rome Italy

Abstract

AimsPatients with heart failure (HF) remain often undertreated for multiple reasons, including treatment inertia, contraindications, and intolerance. The OPTIimal PHARMacological therapy for patients with Heart Failure (OPTIPHARM‐HF) registry is designed to evaluate the prevalence of evidence‐based medical treatment prescription and titration, as well as the causes of its underuse, in a broad real‐world population of consecutive patients with HF across the whole ejection fraction spectrum and among different clinical phenotypes.MethodsThe OPTIPHARM‐HF registry (NCT06192524) is a prospective, multicenter, observational, national study of adult patients with symptomatic HF, as defined by current international guidelines, regardless of ejection fraction. Both outpatients and inpatients with chronic and acute decompensated HF will be recruited. The study will enroll up to 2500 patients with chronic HF at approximately 35 Italian HF centres. Patients will be followed for a maximum duration of 24 months. The primary objective of the OPTIPHARM‐HF registry is to assess prescription and adherence to evidence‐based guideline‐directed medical therapy (GDMT) in patients with HF. The primary outcome is to describe the prevalence of GDMT use according to target guideline recommendation. Secondary objectives include implementation of comorbidity treatment, evaluation of sequence of treatment introduction and up‐titration, description of GDMT implementation in the specific HF population, main causes of GDMT underuse, and assessment of cumulative rate of cardiovascular events.ConclusionThe OPTIPHARM‐HF registry will provide important implications for improving patient care and adoption of recommended medical therapy into clinical practice among HF patients.

Publisher

Wiley

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