PRagmatic Study Of Messaging to Providers of Patients With Heart Failure in Amsterdam UMC (PROMPT-HF-AUMC)
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Folkert Assselbergs, MD PhD
- Phone Number: 0031205669111
- Email: f.w.asselbergs@amsterdamumc.nl
Study Contact Backup
- Name: A Uijl
- Email: a.uijl@amsterdamumc.nl
Study Locations
-
-
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Amsterdam, Netherlands
- Recruiting
- Amsterdam University Medical Centers, location AMC
-
Contact:
- F Asselbergs
- Email: f.w.asselbergs@amsterdamumc.nl
-
Amsterdam, Netherlands
- Recruiting
- Amsterdam University Medical Centers, Location VU Medical Center
-
Contact:
- F Asselberg
- Email: f.w.asselbergs@amsterdamumc.nl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with HFrEF
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Use of guideline-directed medical therapy (GDMT)
Time Frame: 30 days (primary), 6 months (secondary)
|
Using all therapies according to ESC guidelines
|
30 days (primary), 6 months (secondary)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
All-cause mortality
Time Frame: 1 year
|
All-cause mortality
|
1 year
|
|
Hospitalisation for Heart Failure
Time Frame: 6 months, 1 year
|
Hospitalisation for Heart Failure
|
6 months, 1 year
|
|
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)
|
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
|
renal events (>30% serum creatinine increase, hospitalization for acute kidney injury, development of end-stage kidney disease)
|
30 days, 6 months, 1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20230416-C1_v2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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