A Pilot Study to Increase Utilization of GDMT in Patients With HFrEF
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
🗓️ Study Start (Actual) 12 January 2022
🗓️ Primary Completion (Estimated) 25 September 2023
✅ Study Completion (Estimated) 25 September 2023
👥 Enrollment (Estimated) 50
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Los Angeles, California, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 22 December 2021
  • First Submitted that Met QC Criteria 22 December 2021
  • First Posted 27 December 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 30 August 2023
  • Last Update Posted 5 September 2023
  • Last Verified August 2023