Heart FailureDRUM-HFNCT06915584
Drug Management in Heart Failure
An observational study of Heart Failure, run by IRCCS San Raffaele Roma at 1 site in Italy.
Trial summary
Aim of the proposal is to create an interactive AI-based multicentre prospective database to provide information on how to improve the QoC for pts with HF.This will provide detailed information on pts characteristics,treatment practices, adherence to prescribed guideline-based optimal drug therapy,and outcomes.The… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 450 participants
- Where
- 1 siteItaly
- Study dates
- 30 Nov 2024to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Patients with heart Failure
Who may be able to join
- Both gender
- Age >18 years
- Signed informed consent for the study
- Known diagnosis of heart failure > 6 months
- Recent or ongoing hospitalization for heart failure exacerbation
Who cannot join
- Conditions that, in the investigator's judgment, may interfere with the study or contraindicate participation for safety reasons
- Concurrent diagnosis of neoplasia
- Advanced COPD (FEV1 <50%)
- Advanced valvular heart disease (severe mitral-aortic stenosis-insufficiency requiring cardiac surgery)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCs San Raffaele
Rome, RM, 00166
Prof. Maurizio Volterrani, MD, 0652253440, maurizio.volterrani@sanraffaele.it
About this study
Aim of the proposal is to create an interactive AI-based multicentre prospective database to provide information on how to improve the QoC for pts with HF.This will provide detailed information on pts characteristics,treatment practices, adherence to prescribed guideline-based optimal drug therapy,and outcomes.The database stems from a registry started two years ago,conceived to provide a contemporary snapshot on the adherence to the latest European GGLL for the therapeutic management of pts with HF.The database will be integrated with a specifically designed algorithm that provides an accurate feedback on whether patients are properly treated according to the ESC most recent recommendations.The expected outcomes are:-define non-adherence level to GGLL-based recommendations for treatment of HF;-provide information on initiation, adherence and persistence over time of the recommended treatment;-reduce medical inertia;produce practical implications to reduce morbidity and mortality
Read the detailed description
Heart Failure (HF) is a worldwide leading cause of death and continues to increase, with important implications for healthcare providers. International guidelines (GGLL) for patients with HF recommend a combination of drugs to reduce the risk of events and improve patient¿s symptoms. However, the current impact of guideline-directed medical therapies on mortality and morbidity remains limited because population of HF patients is very different from that enrolled in clinical trials, which is much older and therefore suffers multiple comorbidities, with the need of higher precision therapy based on their phenotype. Therefore, medical inertia is another lack of adherence factor and bad outcomes for HF patients. The aim of the proposal is to create an interactive multicentre prospective database initiated to provide information on how to improve the quality of care for patients (pts) with HF. The database will provide detailed information on pts characteristics, treatment practices, adherence to prescribed guideline, based optimal drug therapy and outcomes. Populations and Methods: The database stems from a registry that started two years ago. This registry was conceived to provide a contemporary snapshot adherence to the latest European guidelines for HF. The database will be integrated with a specifically designed artificial intelligence-based algorithm that provides an accurate feedback on whether patients are properly treated according to the European Society of Cardiology (ESC) most recent and updated recommendations for the treatment of patients with HF, suggesting the right therapy and target dosage based on patients¿ phenotype, clinical characteristic and comorbidities. According to HF drug major trials results, the algorithm will calculate the saved hospitalizations, urgent visits for decompensated HF and death for HF. Using an algorithm, created by inquiring about a recently started HF registry, this project will be able to produce practical implications to reduce morbidity and mortality in pts with HF, thanks to the increase of pts adherence to optimal treatments and physician¿s compliance to GGLL.
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Descriptive appropriateness, Registry, Digital therapy
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
create a registry that provides an updated assessment of the pattern of use of treatments recommended by guidelines in order to collect new evidence on compliance with them. Be they European or Italian for the treatment of patients with increased cardiov
Measured: from enrollment to the end of observation al 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start30 Nov 2024
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Mar 2027 (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
- Other
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari, Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915584
- Sponsor's protocol ID
- 162/SR/24
- Acronym
- DRUM-HF
- Status last verified
- Oct 2026
- First submitted
- 31 Mar 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Management in Heart Failure
- ClinicalTrials.gov ID
- NCT06915584
- Acronym / sponsor ID
- DRUM-HF / 162/SR/24
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Descriptive appropriateness, Registry, Digital therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari, Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
- Study start
- 30 Nov 2024 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 8 Apr 2025 (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.
Aim of the proposal is to create an interactive AI-based multicentre prospective database to provide information on how to improve the QoC for pts with HF.This will provide detailed information on pts characteristics,treatment practices, adherence to prescribed guideline-based optimal drug therapy,and outcomes.The database stems from a registry started two years ago,conceived to provide a contemporary snapshot on the adherence to the latest European GGLL for the therapeutic management of pts with HF.The database will be integrated with a specifically designed algorithm that provides an accurate feedback on whether patients are properly treated according to the ESC most recent recommendations.The expected outcomes are:-define non-adherence level to GGLL-based recommendations for treatment of HF;-provide information on initiation, adherence and persistence over time of the recommended treatment;-reduce medical inertia;produce practical implications to reduce morbidity and mortality
Detailed description
Heart Failure (HF) is a worldwide leading cause of death and continues to increase, with important implications for healthcare providers. International guidelines (GGLL) for patients with HF recommend a combination of drugs to reduce the risk of events and improve patient¿s symptoms. However, the current impact of guideline-directed medical therapies on mortality and morbidity remains limited because population of HF patients is very different from that enrolled in clinical trials, which is much older and therefore suffers multiple comorbidities, with the need of higher precision therapy based on their phenotype. Therefore, medical inertia is another lack of adherence factor and bad outcomes for HF patients. The aim of the proposal is to create an interactive multicentre prospective database initiated to provide information on how to improve the quality of care for patients (pts) with HF. The database will provide detailed information on pts characteristics, treatment practices, adherence to prescribed guideline, based optimal drug therapy and outcomes. Populations and Methods: The database stems from a registry that started two years ago. This registry was conceived to provide a contemporary snapshot adherence to the latest European guidelines for HF. The database will be integrated with a specifically designed artificial intelligence-based algorithm that provides an accurate feedback on whether patients are properly treated according to the European Society of Cardiology (ESC) most recent and updated recommendations for the treatment of patients with HF, suggesting the right therapy and target dosage based on patients¿ phenotype, clinical characteristic and comorbidities. According to HF drug major trials results, the algorithm will calculate the saved hospitalizations, urgent visits for decompensated HF and death for HF. Using an algorithm, created by inquiring about a recently started HF registry, this project will be able to produce practical implications to reduce morbidity and mortality in pts with HF, thanks to the increase of pts adherence to optimal treatments and physician¿s compliance to GGLL.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with heart Failure
Key inclusion criteria (5 listed)
- Both gender
- Age >18 years
- Signed informed consent for the study
- Known diagnosis of heart failure > 6 months
- Recent or ongoing hospitalization for heart failure exacerbation
Key exclusion criteria (4 listed)
- Conditions that, in the investigator's judgment, may interfere with the study or contraindicate participation for safety reasons
- Concurrent diagnosis of neoplasia
- Advanced COPD (FEV1 <50%)
- Advanced valvular heart disease (severe mitral-aortic stenosis-insufficiency requiring cardiac surgery)
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
create a registry that provides an updated assessment of the pattern of use of treatments recommended by guidelines in order to collect new evidence on compliance with them. Be they European or Italian for the treatment of patients with increased cardiov
Time frame: from enrollment to the end of observation al 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
Related trials for Heart Failure
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruitingObservational study
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure
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.
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 IRCCS San Raffaele Roma 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 20 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucia Gatta, PhD (+390652253440, lucia.gatta@sanraffaele.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
create a registry that provides an updated assessment of the pattern of use of treatments recommended by guidelines in order to collect new evidence on compliance with them. Be they European or Italian for the treatment of patients with increased cardiov (time frame: from enrollment to the end of observation al 24 months). 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 20 Oct 2026.