Consistently Assess Signs and Symptom of Heart Failure

Heart Failure Clinical Trial

— CLASS-HF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05833581
• Other study ID #: HF-2021-000136
• Status: Recruiting
• Phase: N/A
• Start date: March 17, 2023
• Est. completion date: June 17, 2024

Study information

• Verified date: April 2023
• Source: Board of Trustees of Illinois State University
• Contact: Marilyn A. Prasun, PhD
• Phone: 217-433-2316
• Email: maprasu[@]ilstu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: June 17, 2024
• Est. primary completion date: December 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction
• Heart Failure With Reduced Ejection Fraction

Intervention

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

Locations

Country	Name	City	State
United States	University of Colorado Medical Center	Aurora	Colorado
United States	Lancaster General Health/Penn Medicine	Lancaster	Pennsylvania
United States	Carle BroMenn Medical Center	Normal	Illinois

Sponsors (5)

Lead Sponsor	Collaborator
Board of Trustees of Illinois State University	Abbott, Lancaster General Hospital, University of Colorado, Denver, University of North Carolina, Greensboro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

External 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