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NCT Number: NCT06344910

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

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.

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Key information

Conditions

Heart Failure With Reduced Ejection Fraction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Amsterdam University Medical Centers, Location AMC, Amsterdam, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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.

Primary outcomes

  1. Use of guideline-directed medical therapy (GDMT)

    Time frame: 30 days (primary), 6 months (secondary)

    Using all therapies according to ESC guidelines

Secondary outcomes

  1. All-cause mortality

    Time frame: 1 year

    All-cause mortality

  2. Hospitalisation for Heart Failure

    Time frame: 6 months, 1 year

    Hospitalisation for Heart Failure

  3. other major cardiovascular events (MACE: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke)

    Time frame: 6 months, 1 year

    other major cardiovascular events (MACE: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke)

  4. 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

    renal events (>30% serum creatinine increase, hospitalization for acute kidney injury, development of end-stage kidney disease)

Study contacts

Contact information is provided by the study sponsor or research team.

A Uijl

CONTACT

[email protected]

Folkert Assselbergs, MD PhD

CONTACT

[email protected]

0031205669111

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Collaborators

  • AstraZeneca
  • Yale University

Registry information

Acronym: PROMPT-HF-AUMC

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 3, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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