A Pilot Study to Increase Utilization of GDMT in Patients With HFrEF

Recruiting

• Conditions: Heart Failure
• Interventions: Other: Using a clinical decision software to provide specific recommendation of a medication at a certain dosage

• Registration Number: NCT05170165
• Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary

The purpose of this study is to test a clinical decision support (CDS) tool that provides clinicians (cardiologists and nurse practitioners) medication recommendations regarding guideline directed medical therapy (GDMT) in patients with heart failure and reduced ejection fraction (HFrEF).

Detailed Description

The purpose of our study is to test whether home blood pressure monitoring (HBPM) with clinical-decision support (CDS) will optimize the use of GDMT in patients with HFrEF. HBPM allows cardiologists and NPs to monitor patients outside the clinical setting so that GDMT can be safely initiated and up-titrated. The CDS employs HBPM and electronic medical record (EMR) data to implement the ACC/AHA HF guidelines and provides cardiologists and NPs with GDMT recommendations.

Study Timeline

• Study First Submitted: 2021-12-22
• Study First Submitted QC: 2021-12-22
• Study First Posted: 2021-12-27
• Study Start: 2022-01-12
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-09-05
• Primary Completion: 2023-09-25
• Study Completion: 2023-09-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Diagnosis of HFrEF (left ejection fraction < 40%, assessed by transthoracic echo, cardiac MRI, cardiac SPECT) within the past year.
• New York Heart Association (NYHA) class II-III at most recent screening assessment.
• GDMT composite score of less than or equal to 50% at baseline

Exclusion Criteria

• Previous contraindication to beta blockers, ACE inhibitors, and/or ARB.
• Baseline creatinine > 2 mg/dl or potassium level at baseline > 5 mEq/L or eGFR <30 mL/min/1.73 m2.
• Baseline systolic blood pressure < 100 mmHg.
• Concomitant use of ACE, ARB, and/or ARNI
• Polycystic kidney disease
• History of angioedema
• History of or currently on a transplant list
• Left ventricular assist device
• Uncontrolled asthma
• Severe COPD
• Cirrhosis
• Currently receiving hospice or comfort care
• Patient not proficient with written and spoken English
• Patient has diminished decision making capability
• History of non-compliance

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Enrolled Subjects	Using a clinical decision software to provide specific recommendation of a medication at a certain dosage	Test a clinical decision support (CDS) tool that provides clinicians (cardiologists and nurse practitioners) recommendations regarding guideline directed medical therapy (GDMT) in patients with heart failure and reduced ejection fraction (HFrEF).

Primary Outcome Measures

Name	Time	Method
Proportion of patients at or above 50% target dose of GDMT in HFrEF patients	6 months	Change in the proportion of patients at or above 50% target dose of GDMT in

Secondary Outcome Measures

Name	Time	Method
Percentage of accepted medication recommendations	6 months	The percentage of DE output medication recommendations in which the clinician accepts alerts

Trial Locations

Locations (1)

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States