Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06457152
Other study ID # 24-00179
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2024
Est. completion date December 30, 2025

Study information

Verified date June 2024
Source NYU Langone Health
Contact Sarah Tsuruo
Phone 914-815-4079
Email Sarah.tsuruo@nyulangone.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will test an automated, electronic health record (EHR-)embedded alert to improve prescribing of guideline-directed medical therapy for patients with heart failure and reduced ejection fraction (HFrEF). The investigators have previously tested and implemented this alert at NYU Langone Health (NYULH), and will now test and implement this alert across three other health systems.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 3000
Est. completion date December 30, 2025
Est. primary completion date October 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Patient with an encounter visit at participating cardiology practice during the study period - Patient with EF of less than or equal to 40% on most recent echocardiogram at the time of visit - Patient ages 18-90 Exclusion Criteria: - Pregnancy - Ventricular assist device - Hospice - Cardiac amyloid - Medication-specific exclusion for MRA: most recent systolic blood pressure less than 105 mm Hg, most recent potassium < 5.1, any potassium > 5.5, most recent glomerular filtration rate < 30 (using MDRD equation), or a documented MRA allergy.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
EHR-Emedded Alert
For patients randomized to the intervention group, an automated, EHR-embedded alert will be visible in the patient's chart that promotes appropriate medical therapy for patients with HFrEF.

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts
United States OhioHealth Columbus Ohio
United States NYU Langone Health New York New York
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (4)

Lead Sponsor Collaborator
NYU Langone Health Massachusetts General Hospital, OhioHealth, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Patients with a Prescription for Mineralocorticoid Antagonists (MRA) Measured at the prescription encounter level using patient EHR data. Up to Day 30
Secondary Number of Patients with a Prescription for Beta-Blocker (BB) Measured at the prescription encounter level using patient EHR data. Up to Day 30
Secondary Number of Patients with a Prescription for ACE-I/ARB/ARNI Prescription for angiotensin converting enzyme-inhibitors/angiotensin receptor blockers/angiotensin receptor neprilysin inhibitors (ACE-I/ARB/ARNI) measured at the prescription encounter level using patient EHR data. Up to Month 36
Secondary Number of Patients with a Prescription for Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2i) Measured at the prescription encounter level using patient EHR data. Up to Month 36
Secondary Number of Patients with Hyperkalemia Measured using patient EHR data. Up to Month 36
Secondary Number of Patients who are Hospitalized Measured using patient EHR data. Up to Month 36
Secondary Number of Patients who are Hospitalized for Heart Failure (HF) Measured using patient EHR data. Up to Month 36
See also
  Status Clinical Trial Phase
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Recruiting NCT05654272 - Development of CIRC Technologies
Active, not recruiting NCT05896904 - Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction N/A
Completed NCT05077293 - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Recruiting NCT05631275 - The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
Enrolling by invitation NCT05564572 - Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology N/A
Enrolling by invitation NCT05009706 - Self-care in Older Frail Persons With Heart Failure Intervention N/A
Recruiting NCT04177199 - What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Terminated NCT03615469 - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY) N/A
Recruiting NCT06340048 - Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure Phase 1/Phase 2
Recruiting NCT05679713 - Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
Completed NCT04254328 - The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure N/A
Completed NCT03549169 - Decision Making for the Management the Symptoms in Adults of Heart Failure N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05538611 - Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
Recruiting NCT04262830 - Cancer Therapy Effects on the Heart
Completed NCT06026683 - Conduction System Stimulation to Avoid Left Ventricle Dysfunction N/A
Withdrawn NCT03091998 - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support Phase 1
Recruiting NCT05564689 - Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy