Consistently Assess Signs and Symptom of Heart Failure (CLASS-HF)

Examining the Reliability and Validity of the New York Heart Association Classification Guide to Assign Class for Patients With Heart Failure and Application Into Practice

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Heart Failure With Reduced Ejection Fraction; Heart Failure With Preserved Ejection Fraction
• Intervention / Treatment: Other: New York Heart Association Classification Guide

Detailed Description

As a continuation of prior work, the purpose of this study is to further examine the reliability and validity of the New York Heart Association (NYHA) Classification Guide and application into practice. The investigators will conduct a prospective cross-sectional study in the ambulatory care settings that manages adult patients with chronic heart failure (both heart failure with reduced ejection fraction [HFrEF] and heart failure with preserved ejection fraction [HFpEF]). HF providers will be asked to complete the NYHA classification Guide and assign one of 4 functional classes: Class I, Class II, Class III, or Class IV. Participants will then complete a standardized 6-minute walk test (6MWT), 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. Clinicians will utilize the NYHA Classification Guide for 30 days and will report perceived barriers and facilitators. Data reporting NYHA Class and HF Stage will be obtained from 30 days prior implementation and compared to during implementation.

• Study Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marilyn A. Prasun, PhD; Phone Number: 217-433-2316; Email: maprasu@ilstu.edu
• Study Contact Backup: Name: Kelly D. Stamp, PhD; Phone Number: 303-724-8398; Email: Kelly.Stamp@CUAnschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Not yet recruiting
      • University of Colorado Medical Center
      • Contact: Kelly D. Stamp, PhD; Phone Number: 303-724-8398; Email: Kelly.Stamp@CUAnschutz.edu
  • Illinois
    • Normal, Illinois, United States, 61761
      • Recruiting
      • Carle BroMenn Medical Center
      • Contact: Dory Jarzabkowski, DO; Phone Number: 309-556-8300; Email: dory.jarzabkowski@carle.com
      • Contact: Tami Tallyn, RN; Phone Number: 309-556-8300; Email: tami.tallyn@carle.com
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17602
      • Not yet recruiting
      • Lancaster General Health/Penn Medicine
      • Contact: Lisa D Rathman, MS; Phone Number: 717-397-5484; Email: Lisa.Rathman@pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Participant 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

Participant 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

Provider Inclusion Criteria:

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

Providers Exclusion Criteria:

• Providers who do not actively manage adult patients with HF.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Intervention Study Arm; All participants with HF will be evaluated by their HF providers who will use the NYHA Classification Guide to assist with assignment of HF class. The participant will then complete a 6-minute walk test. Subsequently participating providers will utilize the guide to assess and assign the class of their HF patients in practice.	Other: New York Heart Association Classification Guide; The New York Heart Association Classification Guide is a questionnaire that assists in guiding the provider in selection of the patient's class

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reliability of the New York Heart Association (NYHA) Classification Guide	Experts will assign NYHA class using the guide in 30 selected clinical records. The assigned class results will be compared to determine reliability.	12 weeks
Validity of the New York Heart Association (NYHA) Classification Guide	Providers will assign NYHA class using the guide to assess participants with HF who will then perform a 6-minute walk test.	1 year
Barriers to implementation of the New York Heart Association (NYHA) Classification Guide	Providers will be surveyed following 30-days of using the NYHA Classification Guide in the clinical setting regarding perceived barriers to implementation into practice.	30-days
Facilitators to implementation of the New York Heart Association (NYHA) Classification Guide	Providers will be surveyed following 30-days of using the NYHA Classification Guide in the clinical setting regarding perceived facilitators to implementation into practice.	30-days
Documentation after Implementation of the New York Heart Association (NYHA) Classification Guide	30-days prior and 30-days during implementation of the NYHA Classification Guide in clinical practice, the provider clinic notes from the patient visit will be assessed for documentation of NYHA class (I-IV) and HF stage (A-D).	60-days

Collaborators and Investigators

• Sponsor: Board of Trustees of Illinois State University
• Collaborators: University of Colorado, Denver; Abbott; University of North Carolina, Greensboro; Lancaster General Hospital
• Investigators: Principal Investigator: Marilyn A. Prasun, PhD, Board of Trustees of Illinois State University

Publications and helpful links

Helpful Links

• Providers' Accuracy in Decision-Making with Assessing NYHA Functional Class of Patients with Heart Failure after use of a Classification Guide
• Providers' assignment of NYHA functional class in patients with heart failure: A vignette study

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2023
• Primary Completion (Anticipated): December 17, 2023
• Study Completion (Anticipated): June 17, 2024

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: April 17, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: HF-2021-000136

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Aggregate data will be published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No