Consistently Assess Signs and Symptom of Heart Failure
Heart failure (HF) is a major public health problem. The New York Heart Association (NYHA) Functional Classification by a HF provider helps to guide their decisions in patient treatment. The purpose of this study is to further examine the NYHA Classification Guide that is designed to assist healthcare providers. The investigators will conduct the study in the outpatient clinic setting where adult patients with chronic heart failure are treated. HF providers will be asked to complete the NYHA classification Guide and then participants will complete a standardized 6-minute walk test which is considered as the gold standard. Participant results will be compared between providers' assigned class and the results from the 6-minute walk test. The subsequent phase of the study will be incorporation of the NYHA Classification Guide into clinical practice. HF providers will use the NYHA Classification Guide for 30 days in the clinic setting and will report their perceptions.
Conditions:
🦠 Heart Failure 🦠 Heart Failure With Reduced Ejection Fraction 🦠 Heart Failure With Preserved Ejection Fraction
🗓️ Study Start (Actual) 17 March 2023
🗓️ Primary Completion (Estimated) 17 December 2023
✅ Study Completion (Estimated) 17 June 2024
👥 Enrollment (Estimated) 104
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Aurora, Colorado, United States
📍 Normal, Illinois, United States
📍 Lancaster, Pennsylvania, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * A documented confirmed diagnosis of Heart Failure (HF)
    • * Under the care of a Cardiologist and/or Advanced Practice Provider working in Cardiology
    • * 18 years of age or older and less than 90 years of age
    • * Alert and oriented to person, place, and time
    • * Ability to walk without assistance
    • * Able to read and speak English

    Exclusion Criteria:

    • * Diagnosed with myocardial infarction, coronary artery bypass graft (CABG), angioplasty or stent in the previous 30-days
    • * Unstable angina in the previous 30 days
    • * Active endocarditis
    • * Acute myocarditis or pericarditis
    • * Symptomatic severe aortic stenosis
    • * Uncontrolled hypertension with systolic blood pressure readings \> 180 mmHg or diastolic pressure readings \> 100 mmHg
    • * Uncontrolled atrial dysrhythmia or 3rd degree heart block
    • * Active ventricular arrhythmias resulting in 1 or more shocks in the past month
    • * Acute pulmonary embolus or pulmonary infection
    • * Thrombosis of the lower extremities
    • * Suspected dissecting aneurysm
    • * Uncontrolled asthma
    • * Pulmonary edema
    • * Room air oxygen saturation (SPO2) at rest less than 90%
    • * Acute respiratory failure
    • * Acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise such as, infection, thyrotoxicosis
    • * Left ventricular assist device
    • * Mental impairment leading to inability to cooperate

    Inclusion Criteria:

    • • Licensed healthcare providers (Physicians and Advance Practice Providers) in HF ambulatory clinical sites who care for adult patients with HF.

    Exclusion Criteria:

    • • Providers who do not actively manage adult patients with HF.
Ages Eligible for Study: 18 Years to 90 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ 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 28 March 2023
  • First Submitted that Met QC Criteria 17 April 2023
  • First Posted 27 April 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 17 April 2023
  • Last Update Posted 27 April 2023
  • Last Verified April 2023