- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06344910
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
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 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Use of guideline-directed medical therapy (GDMT)
Time Frame: 30 days (primary), 6 months (secondary)
|
30 days (primary), 6 months (secondary)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
All-cause mortality
Time Frame: 1 year
|
1 year
|
Hospitalisation for Heart Failure
Time Frame: 6 months, 1 year
|
6 months, 1 year
|
other major cardiovascular events (MACE: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke)
Time Frame: 6 months, 1 year
|
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
|
30 days, 6 months, 1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
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 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.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Failure With Reduced Ejection Fraction
-
Novartis PharmaceuticalsCompletedHeart Failure With Reduced Ejection Fraction (HFrEF) | or Heart Failure With Mildly Reduced Ejection Fraction (HFmrEF)Netherlands, United States
-
University of SienaEuropean Association of Cardiovascular ImagingActive, not recruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure With Mid Range Ejection FractionSpain, Greece, Turkey, Portugal, Australia, Belgium, Italy, Mexico, Netherlands, North Macedonia, Romania, Tunisia
-
University Hospital, AkershusNovartisActive, not recruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionNorway
-
Milton S. Hershey Medical CenterWithdrawnHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionUnited States
-
Board of Trustees of Illinois State UniversityUniversity of Colorado, Denver; Abbott; University of North Carolina, Greensboro and other collaboratorsRecruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionUnited States
-
Medical University of South CarolinaCompletedHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Normal Ejection FractionUnited States
-
Milton S. Hershey Medical CenterCompletedHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection FractionUnited States
-
Massachusetts General HospitalRoche DiagnosticsRecruitingCardiovascular Risk Factor | Heart Failure With Reduced Ejection Fraction | Heart Failure With Normal Ejection Fraction | Heart Failure, Right Sided | Heart Failure With Mid Range Ejection FractionUnited States
-
Occlutech International ABActive, not recruitingHeart Failure With Preserved Ejection Fraction (HFpEF) | Heart Failure With Reduced Ejection Fraction (HFrEF)United States
-
Fondazione Toscana Gabriele MonasterioAzienda Ospedaliera Città della Salute e della Scienza di TorinoNot yet recruitingHeart Failure | Heart Failure With Reduced Ejection Fraction | Heart Failure With Midrange Ejection FractionItaly
Clinical Trials on Best practice alert for the notification of patients with HFrEF and recommended evidence-based therapies
-
Yale UniversityAstraZenecaCompletedHeart Failure With Reduced Ejection FractionUnited States
-
Yale UniversityAstraZenecaCompletedHeart FailureUnited States
-
Fudan UniversityShanghai Zhongshan Hospital; Huashan Hospital; Children's Hospital of Fudan University and other collaboratorsRecruitingQuality Improvement | Central Venous Catheter Associated Bloodstream Infection | CLABSI - Central Line Associated Bloodstream Infection | Central Venous Catheter Related Bloodstream Infection | Central Line Infection | CRBSI - Catheter Related Bloodstream Infection | Evidence-based Nursing PracticeChina
-
Beijing Tiantan HospitalNot yet recruitingRespiratory Failure | Respiratory Infection Virus
-
Memorial Sloan Kettering Cancer CenterTerminatedFibrillation | Post-Operative Cancer Patients Experiencing AtrialUnited States
-
BonusBio Group LtdCompletedBone Void in the Maxillofacial AreaIsrael
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)CompletedNeuroblastomaUnited States
-
Rabin Medical CenterTel Aviv University; The Leona M. and Harry B. Helmsley Charitable TrustRecruiting