Consistently Assess Signs and Symptom of Heart Failure

NCT ID: NCT05833581

Last Updated: 2023-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-17
• Study Completion Date: 2024-06-17

Brief 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.

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.

Conditions

Heart Failure; Heart Failure With Reduced Ejection Fraction; Heart Failure With Preserved Ejection Fraction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

New York Heart Association Classification Guide

Intervention Type: OTHER

The New York Heart Association Classification Guide is a questionnaire that assists in guiding the provider in selection of the patient's class

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

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

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

Lancaster General Hospital

OTHER

Sponsor Role: collaborator

University of North Carolina, Greensboro

OTHER

Sponsor Role: collaborator

Abbott

INDUSTRY

Sponsor Role: collaborator

Board of Trustees of Illinois State University

OTHER

Sponsor Role: lead

Responsible Party

Marilyn Prasun

Professor, Carle BroMenn Medical Center Endowed Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marilyn A. Prasun, PhD

Role: PRINCIPAL_INVESTIGATOR

Board of Trustees of Illinois State University

Locations

University of Colorado Medical Center

Aurora, Colorado, United States

Site Status: NOT_YET_RECRUITING

Carle BroMenn Medical Center

Normal, Illinois, United States

Site Status: RECRUITING

Lancaster General Health/Penn Medicine

Lancaster, Pennsylvania, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Marilyn A. Prasun, PhD

Role: CONTACT

maprasu@ilstu.edu

217-433-2316

Kelly D. Stamp, PhD

Role: CONTACT

Kelly.Stamp@CUAnschutz.edu

303-724-8398

Facility Contacts

Kelly D. Stamp, PhD

Role: primary

Kelly.Stamp@CUAnschutz.edu

303-724-8398

Dory Jarzabkowski, DO

Role: primary

dory.jarzabkowski@carle.com

309-556-8300

Tami Tallyn, RN

Role: backup

tami.tallyn@carle.com

309-556-8300

Lisa D Rathman, MS

Role: primary

Lisa.Rathman@pennmedicine.upenn.edu

717-397-5484

Related Links

http://doi.org/10.1016/j.hrtlng.2022.03.017

Providers' Accuracy in Decision-Making with Assessing NYHA Functional Class of Patients with Heart Failure after use of a Classification Guide

http://doi.org/10.1016/j.hrtlng.2021.07.009

Providers' assignment of NYHA functional class in patients with heart failure: A vignette study

Other Identifiers

HF-2021-000136

Identifier Type: -

Identifier Source: org_study_id