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

NCT06344910 | Recruiting FDA Drug

• 1 other identifier: 20230416-C1_v2
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure With Reduced Ejection Fraction

Keywords

electronic health records; electronic nudge; guideline directed medical therapy

Outcome Measures

Primary Outcomes (1)

• Use of guideline-directed medical therapy (GDMT)

  Using all therapies according to ESC guidelines

  30 days (primary), 6 months (secondary)

Secondary Outcomes (4)

• All-cause mortality

  1 year

• Hospitalisation for Heart Failure

  6 months, 1 year

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

  6 months, 1 year

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

  30 days, 6 months, 1 year

Study Arms (1)

Patients with HFrEF

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

Interventions

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.

Patients with HFrEF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with heart failure and reduced ejection fraction

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• AstraZeneca: collaborator
• Yale University: collaborator

Study Sites (2)

Amsterdam University Medical Centers, Location AMC

Amsterdam, Netherlands

RECRUITING

Amsterdam University Medical Centers, Location VU Medical Center

Amsterdam, Netherlands

RECRUITING

Central Study Contacts

Folkert Assselbergs, MD PhD

CONTACT

0031205669111; f.w.asselbergs@amsterdamumc.nl

A Uijl

CONTACT

a.uijl@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 3, 2024
• Study Start: May 21, 2024
• Primary Completion: May 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: available upon request
• Access Criteria: available upon request

Locations

NL (2)