Heart FailureOPTIPHARM-HFNCT06192524
OPTImal PHARMacological Therapy for Patients With Heart Failure: The OPTIPHARM-HF Registry
An observational study of Heart Failure, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 2,000 participants
- Where
- 1 siteItaly
- Study dates
- 18 Jul 2022to 1 Oct 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with symptomatic HF. Both outpatients and in-patients with chronic and acute decompensated HF will be consecutively recruited.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
ASST Spedali Civili
Brescia, 25123
Cristina Gussago, 030 3996927, studiclinici.brescia@gmail.com
Riccardo M. Inciardi, MD
About this study
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).
Read the 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.
- Conditions
- Heart Failure
- Keywords
- GDMT, HFrEF, HFpEF, Clinical Outcomes
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
GDMT sequencing and up-titration
Measured: 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
GDMT in specific HF population
Measured: 1 year
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start18 Jul 2022
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy, Centro Cardiologico Monzino, A.O. Ospedale Papa Giovanni XXIII, IRCCS Ospedale San Raffaele, Azienda Ospedaliera Universitaria Senese, Humanitas Research Hospital IRCCS, Rozzano-Milan, Ospedale Policlinico San Martino, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Fondazione IRCCS Policlinico San Matteo di Pavia, Ospedali Riuniti di Foggia, A.O.U. Città della Salute e della Scienza, ASU Giuliano Isontina, Trieste, Azienda Ospedaliera S. Maria della Misericordia, IRCCS Policlinico S. Donato, ASST Santi Paolo e Carlo
- Responsible party
- Principal investigator, Marco METRA, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Investigators
- Marco Metra, MD, Principal investigator, ASST Spedali CiviliRiccardo M. Inciardi, MD, PhD, Principal investigator, ASST Spedali Civili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192524
- Sponsor's protocol ID
- NP5441
- Acronym
- OPTIPHARM-HF
- Status last verified
- Dec 2023
- First submitted
- 21 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTImal PHARMacological Therapy for Patients With Heart Failure: The OPTIPHARM-HF Registry
- ClinicalTrials.gov ID
- NCT06192524
- Acronym / sponsor ID
- OPTIPHARM-HF / NP5441
- Conditions
- Heart Failure
- Keywords
- GDMT, HFrEF, HFpEF, Clinical Outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Collaborators
- Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy, Centro Cardiologico Monzino, A.O. Ospedale Papa Giovanni XXIII, IRCCS Ospedale San Raffaele, Azienda Ospedaliera Universitaria Senese, Humanitas Research Hospital IRCCS, Rozzano-Milan, Ospedale Policlinico San Martino, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Fondazione IRCCS Policlinico San Matteo di Pavia, Ospedali Riuniti di Foggia, A.O.U. Città della Salute e della Scienza, ASU Giuliano Isontina, Trieste, Azienda Ospedaliera S. Maria della Misericordia, IRCCS Policlinico S. Donato, ASST Santi Paolo e Carlo
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with symptomatic HF. Both outpatients and in-patients with chronic and acute decompensated HF will be consecutively recruited.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 1 year
GDMT Prevalence and dosing
3 secondary outcomes
To evaluate sequence of introduction of recommended GDMT, medications' up titration, when needed, maintenance of evidence-based treatment during follow-up
Time frame: 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
Time frame: 1 year
To assess cumulative rate of CV events and the impact on prognosis of GDMT and its doses.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Metra, MD principal investigator
ASST Spedali Civili
Riccardo M. Inciardi, MD, PhD principal investigator
ASST Spedali Civili
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cristina Gussago (030 3996927, studiclinici.brescia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024; AzTrials last refreshed its copy on 6 Nov 2026.