Recruiting NCT06344910
PRagmatic Study Of Messaging to Providers of Patients With Heart Failure in Amsterdam UMC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Best practice alert for the notification of patients with HFrEF and recommended evidence-based therapies.
- Who it may be relevant to
- Registry conditions: Heart Failure With Reduced Ejection Fraction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other Best 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 re
Primary outcome measures
- Use of guideline-directed medical therapy (GDMT) [Time frame: 30 days (primary), 6 months (secondary)]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 2 centers
- Amsterdam University Medical Centers, Location AMC — Amsterdam
- Amsterdam University Medical Centers, Location VU Medical Center — Amsterdam
Identifiers
NCT: NCT06344910 · 20230416-C1_v2