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

Heart Failure With Reduced Ejection Fraction Clinical Trial

— PROMPT-HF-AUMC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06344910
• Other study ID #: 20230416-C1_v2
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Folkert Assselbergs, MD PhD
• Phone: 0031205669111
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective cohort study, where we 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 900
• Est. completion date: December 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

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 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 monthts, in which a paired and a before and after analysis will be performed to evaluate the effect of the alert.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	AstraZeneca, Yale University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of guideline-directed medical therapy (GDMT)		30 days (primary), 6 months (secondary)
Secondary	All-cause mortality		1 year
Secondary	Hospitalisation for Heart Failure		6 months, 1 year
Secondary	other major cardiovascular events (MACE: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke)		6 months, 1 year
Secondary	renal events (>30% serum creatinine increase, hospitalization for acute kidney injury, development of end-stage kidney disease)		30 days, 6 months, 1 year