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PRagmatic Study Of Messaging to Providers of Patients With Heart Failure in Amsterdam UMC

PRagmatic Study Of Messaging to Providers of Patients With Heart Failure in Amsterdam UMC

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06344910
Acronym
PROMPT-HF-AUMC
Enrollment
900
Registered
2024-04-03
Start date
2024-05-21
Completion date
2025-12-31
Last updated
2024-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure With Reduced Ejection Fraction

Keywords

electronic health records, electronic nudge, guideline directed medical therapy

Brief 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 in the Netherlands.

Interventions

OTHERBest practice alert for the notification of patients with HFrEF and recommended evidence-based therapies

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.

Sponsors

AstraZeneca
CollaboratorINDUSTRY
Yale University
CollaboratorOTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* Opt-out for the use of routine clinical data for research purposes

Design outcomes

Primary

MeasureTime frameDescription
Use of guideline-directed medical therapy (GDMT)30 days (primary), 6 months (secondary)Using all therapies according to ESC guidelines

Secondary

MeasureTime frameDescription
All-cause mortality1 yearAll-cause mortality
Hospitalisation for Heart Failure6 months, 1 yearHospitalisation for Heart Failure
other major cardiovascular events (MACE: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke)6 months, 1 yearother major cardiovascular events (MACE: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke)
renal events (>30% serum creatinine increase, hospitalization for acute kidney injury, development of end-stage kidney disease)30 days, 6 months, 1 yearrenal events (\>30% serum creatinine increase, hospitalization for acute kidney injury, development of end-stage kidney disease)

Countries

Netherlands

Contacts

Primary ContactFolkert Assselbergs, MD PhD
f.w.asselbergs@amsterdamumc.nl0031205669111
Backup ContactA Uijl
a.uijl@amsterdamumc.nl

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026