OPTImal PHARMacological Therapy for Patients With Heart Failure: The OPTIPHARM-HF Registry
OPTIPHARM-HF
1 other identifier
observational
2,000
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 18, 2022
CompletedFirst Submitted
Initial submission to the registry
December 21, 2023
CompletedFirst Posted
Study publicly available on registry
January 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedJanuary 5, 2024
December 1, 2023
2.2 years
December 21, 2023
December 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
To evaluate sequence of introduction of recommended GDMT, medications' up titration, when needed, maintenance of evidence-based treatment during follow-up
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
1 year
To assess cumulative rate of CV events and the impact on prognosis of GDMT and its doses.
2 years
Eligibility Criteria
Consecutive patients with symptomatic HF. Both outpatients and in-patients with chronic and acute decompensated HF will be consecutively recruited.
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescialead
- Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italycollaborator
- Centro Cardiologico Monzinocollaborator
- A.O. Ospedale Papa Giovanni XXIIIcollaborator
- IRCCS Ospedale San Raffaelecollaborator
- Azienda Ospedaliera Universitaria Senesecollaborator
- Humanitas Research Hospital IRCCS, Rozzano-Milancollaborator
- Ospedale Policlinico San Martinocollaborator
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinicocollaborator
- Fondazione IRCCS Policlinico San Matteo di Paviacollaborator
- Ospedali Riuniti di Foggiacollaborator
- A.O.U. Città della Salute e della Scienzacollaborator
- ASU Giuliano Isontina, Triestecollaborator
- Azienda Ospedaliera S. Maria della Misericordiacollaborator
- IRCCS Policlinico S. Donatocollaborator
- ASST Santi Paolo e Carlocollaborator
Study Sites (1)
ASST Spedali Civili
Brescia, 25123, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marco Metra, MD
ASST Spedali Civili
- PRINCIPAL INVESTIGATOR
Riccardo M. Inciardi, MD, PhD
ASST Spedali Civili
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Marco Metra
Study Record Dates
First Submitted
December 21, 2023
First Posted
January 5, 2024
Study Start
July 18, 2022
Primary Completion
October 1, 2024
Study Completion
October 1, 2025
Last Updated
January 5, 2024
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share