Heart Failure Clinical Trial

Consistently Assess Signs and Symptom of Heart Failure

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Heart Failure

Estimated Enrollment:

104

Study ID:

NCT05833581

Recruitment Status:

Recruiting

Sponsor:

Board of Trustees of Illinois State University

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There are 3 Locations for this study

See Locations Near You

University of Colorado Medical Center
Aurora Colorado, 80045, United States More Info
Kelly D. Stamp, PhD
Contact
303-724-8398
[email protected]
Carle BroMenn Medical Center
Normal Illinois, 61761, United States More Info
Dory Jarzabkowski, DO
Contact
309-556-8300
[email protected]
Tami Tallyn, RN
Contact
309-556-8300
[email protected]
Lancaster General Health/Penn Medicine
Lancaster Pennsylvania, 17602, United States More Info
Lisa D Rathman, MS
Contact
717-397-5484
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

104

Study ID:

NCT05833581

Recruitment Status:

Recruiting

Sponsor:


Board of Trustees of Illinois State University

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