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

Heart Failure Clinical Trial

Official title:

A Pilot Study to Increase Utilization of Guideline Directed Medical Therapy in Patients With HFrEF

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05170165
• Other study ID #: HFDTx study 1618
• Status: Recruiting
• Start date: January 12, 2022
• Est. completion date: September 25, 2023

Study information

• Verified date: August 2023
• Source: Cedars-Sinai Medical Center
• Contact: Allison Peterson, PhD
• Phone: 424-314-0048
• Email: allison.peterson[@]csmns.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 25, 2023
• Est. primary completion date: September 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Using a clinical decision software to provide specific recommendation of a medication at a certain dosage
During routine follow-up, clinicians, cardiologists, and NPs who have a scheduled visit with an enrolled patient will be offered a medication recommendation. The medication recommendation will be generated by the clinical decision support tool. The software will advise the cardiologist whether an HF medication should be initiated, discontinued, or the dosage titrated and if the patient requires labs. In addition, the software, or decision engine (DE), will be run once weekly and every time the patient has new basic metabolic panel results. If the patient is admitted to the hospital, skilled nursing facility, or inpatient rehabilitation unit, the use of DE will be placed on hold until the patient is discharged and at home.

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients at or above 50% target dose of GDMT in HFrEF patients	Change in the proportion of patients at or above 50% target dose of GDMT in	6 months
Secondary	Percentage of accepted medication recommendations	The percentage of DE output medication recommendations in which the clinician accepts alerts	6 months