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

Cedars-Sinai Medical Center

Status: Enrolling

Conditions: Heart Failure

Treatments: Other: Using a clinical decision software to provide specific recommendation of a medication at a certain dosage

Study type: Observational

Funder types: Other

Identifiers

NCT05170165

HFDTx study 1618

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Enrolled Subjects

Description:

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).

Treatment:

Other: Using a clinical decision software to provide specific recommendation of a medication at a certain dosage