Recruiting

Heart Failure

Sponsor:

Board of Trustees of Illinois State University

Code:

NCT05833581

Conditions

Heart Failure

Heart Failure With Reduced Ejection Fraction

Heart Failure With Preserved Ejection Fraction

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

New York Heart Association Classification Guide

Study Details

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.

Conditions

Heart Failure

Heart Failure With Reduced Ejection Fraction

Heart Failure With Preserved Ejection Fraction

Study ID

NCT05833581

Start date

Mar 17, 2023

Status verified date

Apr, 2023

Completion date

Jun 17, 2024

Anticipated

Primary completion date

Dec 17, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

104 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

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

Primary outcome measure

  • Reliability of the New York Heart Association (NYHA) Classification Guide [ Time Frame: 12 weeks ]
  • Validity of the New York Heart Association (NYHA) Classification Guide [ Time Frame: 1 year ]
  • Barriers to implementation of the New York Heart Association (NYHA) Classification Guide [ Time Frame: 30-days ]
  • Facilitators to implementation of the New York Heart Association (NYHA) Classification Guide [ Time Frame: 30-days ]
  • Documentation after Implementation of the New York Heart Association (NYHA) Classification Guide [ Time Frame: 60-days ]

Central Contacts and Locations

Central contacts

Marilyn A. Prasun, PhD

217-433-2316maprasu@ilstu.edu

Kelly D. Stamp, PhD

303-724-8398Kelly.Stamp@CUAnschutz.edu

Locations

Carle BroMenn Medical Center

Recruiting

Normal, Illinois, United States, 61761

Contacts

Dory Jarzabkowski, DO

309-556-8300dory.jarzabkowski@carle.com

Tami Tallyn, RN

309-556-8300tami.tallyn@carle.com

More Information

Sponsor

Board of Trustees of Illinois State University

Last update posted

Apr 27, 2023

Last verified

Apr, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Board of Trustees of Illinois State University on 2023-04-27.