Heart Failure With Reduced Ejection FractionPROMPT-HF-AUMCNCT06344910
PRagmatic Study Of Messaging to Providers of Patients With Heart Failure in Amsterdam UMC
An observational study of Heart Failure With Reduced Ejection Fraction, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in Netherlands.
Trial summary
This is a prospective cohort study, where the investigators aim to investigate the effect of implementation of an electronic nudge alerting clinicians to the prescription of the 4 key pharmacological classes for the treatment of patients with heart failure and reduced ejection fraction (HFrEF) at the outpatient clinic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Best practice alert for the notification of patients with HFrEF and recommended evidence-based therapies
- How many people
- 900 participants
- Where
- 2 sitesNetherlands
- Study dates
- 21 May 2024to Dec 2025
- 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: Patients with heart failure and reduced ejection fraction
Who may be able to join
- Age > 18 years
- Treatment for HFrEF at the outpatient clinic cardiology.
- Documented reduced ejection fraction of <40% based on cardiac ultrasound or cardiac magnetic resonance imaging.
Who cannot join
- Opt-out for the use of routine clinical data for research purposes
Trial locations and contacts
2 sites in 1 country.
A Uijl contact
Netherlands2 sites, 2 recruiting
- Recruiting
Amsterdam University Medical Centers, Location AMC
Amsterdam
F Asselbergs, f.w.asselbergs@amsterdamumc.nl
- Recruiting
Amsterdam University Medical Centers, Location VU Medical Center
Amsterdam
F Asselberg, f.w.asselbergs@amsterdamumc.nl
About this study
This is a prospective cohort study, where the investigators aim to investigate the effect of implementation of an electronic nudge alerting clinicians to the prescription of the 4 key pharmacological classes for the treatment of patients with heart failure and reduced ejection fraction (HFrEF) at the outpatient clinic in the Netherlands.
- Being tested
- Best practice alert for the notification of patients with HFrEF and recommended evidence-based therapies
- Keywords
- electronic health records, electronic nudge, guideline directed medical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best practice alert for the notification of patients with HFrEF and recommended evidence-based therapiesOther
An algorithm will check if the patients if the patient has an age >18 year and is treated at the cardiology department for HFrEF. The use of GDMT is determined using prescriptions data electronic health records (EHR). If the patient does not receive treatment for all 4 drug classes (ACE/ARB/ARNi, beta-blocker, MRA, SGLT2-inhibitor), an electronic alert will be displayed suggesting the clinician to prescribe additional medication when clinically indicated, including relevant recent laboratory results (renal function and electrolytes) and other relevant measures (LVEF, blood pressure and heart rate). The alert is linked to an order set to aid in the prescription of GDMT according to current guidelines.
Results will compared to a retrospective cohort (t=-12 to t=-6) months, and a silent mode cohort (t=-6 to t=0 months, in which a paired and a before and after analysis will be performed to evaluate the effect of the alert.
| Study group | Role | What they receive |
|---|---|---|
| Patients with HFrEF | Not described Receives: Other: Best practice alert for the notification of patients with HFrEF and recommended evidence-based therapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of guideline-directed medical therapy (GDMT)
Using all therapies according to ESC guidelines
Measured: 30 days (primary), 6 months (secondary)
Secondary outcomes (4)
All-cause mortality
All-cause mortality
Measured: 1 year
Hospitalisation for Heart Failure
Hospitalisation for Heart Failure
Measured: 6 months, 1 year
other major cardiovascular events (MACE: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke)
other major cardiovascular events (MACE: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke)
Measured: 6 months, 1 year
renal events (>30% serum creatinine increase, hospitalization for acute kidney injury, development of end-stage kidney disease)
renal events (>30% serum creatinine increase, hospitalization for acute kidney injury, development of end-stage kidney disease)
Measured: 30 days, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start21 May 2024
- Primary completionMay 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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
- 900 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Yale University
- Responsible party
- Principal investigator, Prof. Dr. Folkert W. Asselbergs, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344910
- Sponsor's protocol ID
- 20230416-C1_v2
- Acronym
- PROMPT-HF-AUMC
- Status last verified
- Aug 2024
- First submitted
- 28 Mar 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data underlying the results for publication can be made available upon request
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRagmatic Study Of Messaging to Providers of Patients With Heart Failure in Amsterdam UMC
- ClinicalTrials.gov ID
- NCT06344910
- Acronym / sponsor ID
- PROMPT-HF-AUMC / 20230416-C1_v2
- Keywords
- electronic health records, electronic nudge, guideline directed medical therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- AstraZeneca, Yale University
- Study start
- 21 May 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 Apr 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.
This is a prospective cohort study, where the investigators aim to investigate the effect of implementation of an electronic nudge alerting clinicians to the prescription of the 4 key pharmacological classes for the treatment of patients with heart failure and reduced ejection fraction (HFrEF) at the outpatient clinic in the Netherlands.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with HFrEF | – | Other: Best practice alert for the notification of patients with HFrEF and recommended evidence-based therapies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with heart failure and reduced ejection fraction
Key inclusion criteria (3 listed)
- Age > 18 years
- Treatment for HFrEF at the outpatient clinic cardiology.
- Documented reduced ejection fraction of <40% based on cardiac ultrasound or cardiac magnetic resonance imaging.
Key exclusion criteria (1 listed)
- Opt-out for the use of routine clinical data for research purposes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best practice alert for the notification of patients with HFrEF and recommended evidence-based therapiesAn algorithm will check if the patients if the patient has an age >18 year and is treated at the cardiology department for HFrEF. The use of GDMT is determined using prescriptions data electronic health records (EHR). If the patient does not receive treatment for all 4 drug classes (ACE/ARB/ARNi, beta-blocker, MRA, SGLT2-inhibitor), an electronic alert will be displayed suggesting the clinician to prescribe additional medication when clinically indicated, including relevant recent laboratory results (renal function and electrolytes) and other relevant measures (LVEF, blood pressure and heart rate). The alert is linked to an order set to aid in the prescription of GDMT according to current guidelines. Results will compared to a retrospective cohort (t=-12 to t=-6) months, and a silent mode cohort (t=-6 to t=0 months, in which a paired and a before and after analysis will be performed to evaluate the effect of the alert. | Other | Patients with HFrEF |
Primary outcome
Use of guideline-directed medical therapy (GDMT)
Time frame: 30 days (primary), 6 months (secondary)
Using all therapies according to ESC guidelines
4 secondary outcomes
All-cause mortality
Time frame: 1 year
Hospitalisation for Heart Failure
Time frame: 6 months, 1 year
other major cardiovascular events (MACE: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke)
Time frame: 6 months, 1 year
renal events (>30% serum creatinine increase, hospitalization for acute kidney injury, development of end-stage kidney disease)
Time frame: 30 days, 6 months, 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: Yes. Anonymized data underlying the results for publication can be made available upon request
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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.
A Uijl contact
2 sites 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 With Reduced Ejection Fraction, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in Netherlands.
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 3 inclusion and 1 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 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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 Folkert Assselbergs, MD PhD (0031205669111, f.w.asselbergs@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of guideline-directed medical therapy (GDMT) (time frame: 30 days (primary), 6 months (secondary)). 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 9 Aug 2024.