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

NCT05170165 | Unknown

• 1 other identifier: HFDTx study 1618
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of accepted medication recommendations

  6 months

Study Arms (1)

Enrolled Subjects

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).

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

Interventions

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

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.

Enrolled Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients \>18 years with HFrEF who have suboptimal HF medical regimen

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Raj Khandwalla, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allison Peterson, PhD

CONTACT

424-314-0048; allison.peterson@csmns.org

Maurice Herring

CONTACT

310-248-8375; maurice.herring@cshs.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiovascular Education, Cedars Sinai Care Foundation

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: December 27, 2021
• Study Start: January 12, 2022
• Primary Completion: September 25, 2023
• Study Completion: September 25, 2023
• Last Updated: September 5, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Immediately following publication and ending 2 years.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

US (1)