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

Recruiting

• Conditions: Heart Failure With Reduced Ejection Fraction
• Interventions: Other: Best practice alert for the notification of patients with HFrEF and recommended evidence-based therapies

• Registration Number: NCT06344910
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-28
• Study First Submitted QC: 2024-03-28
• Study First Posted: 2024-04-03
• Study Start: 2024-05-21
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09
• Primary Completion: 2025-05
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 900

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Hospitalisation for Heart Failure	6 months, 1 year	Hospitalisation for Heart Failure
renal events (>30% serum creatinine increase, hospitalization for acute kidney injury, development of end-stage kidney disease)	30 days, 6 months, 1 year	renal events (\>30% serum creatinine increase, hospitalization for acute kidney injury, development of end-stage kidney disease)
All-cause mortality	1 year	All-cause mortality
other major cardiovascular events (MACE: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke)	6 months, 1 year	other major cardiovascular events (MACE: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke)

Trial Locations

Locations (2)

Amsterdam University Medical Centers, Location AMC; 🇳🇱 Amsterdam, Netherlands

Amsterdam University Medical Centers, Location VU Medical Center; 🇳🇱 Amsterdam, Netherlands