Heart FailureCLASS-HFNCT05833581
Consistently Assess Signs and Symptom of Heart Failure
A study testing New York Heart Association Classification Guide in people with Heart Failure and Heart Failure With Reduced Ejection Fraction, run by Board of Trustees of Illinois State University at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Heart Failure With Reduced Ejection Fraction, Heart Failure With Preserved Ejection Fraction
- What is being tested?
- New York Heart Association Classification Guide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Mar 2023to 17 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Not yet recruiting
University of Colorado Medical Center
Aurora, Colorado, 80045
Kelly D. Stamp, PhD, 303-724-8398, Kelly.Stamp@CUAnschutz.edu
- Not yet recruiting
Lancaster General Health/Penn Medicine
Lancaster, Pennsylvania, 17602
Lisa D Rathman, MS, 717-397-5484, Lisa.Rathman@pennmedicine.upenn.edu
- Recruiting
Carle BroMenn Medical Center
Normal, Illinois, 61761
Dory Jarzabkowski, DO, 309-556-8300, dory.jarzabkowski@carle.com
Tami Tallyn, RN, 309-556-8300, tami.tallyn@carle.com
About this study
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
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.
Read the 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
- Being tested
- New York Heart Association Classification Guide
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New York Heart Association Classification GuideOther
The New York Heart Association Classification Guide is a questionnaire that assists in guiding the provider in selection of the patient's class
| Study group | Role | What they receive |
|---|---|---|
| Single Intervention Study Arm | Experimental | 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. Receives: Other: New York Heart Association Classification Guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 60-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start17 Mar 2023
- Primary completion17 Dec 2023 (estimated)
- Study completion17 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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 \[HFpEF\]).
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Board of Trustees of Illinois State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver, Lancaster General Hospital, University of North Carolina, Greensboro, Abbott
- Responsible party
- Principal investigator, Marilyn Prasun, Board of Trustees of Illinois State University
- Investigators
- Marilyn A. Prasun, PhD, Principal investigator, Board of Trustees of Illinois State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833581
- Sponsor's protocol ID
- HF-2021-000136
- Acronym
- CLASS-HF
- Status last verified
- Apr 2023
- First submitted
- 28 Mar 2023
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Aggregate data will be published.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05833581
- Acronym / sponsor ID
- CLASS-HF / HF-2021-000136
- Conditions
- Heart Failure, Heart Failure With Reduced Ejection Fraction, Heart Failure With Preserved Ejection Fraction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Board of Trustees of Illinois State UniversityUniversity, hospital or other
- Collaborators
- University of Colorado, Denver, Lancaster General Hospital, University of North Carolina, Greensboro, Abbott
- Study start
- 17 Mar 2023 (actual)
- Primary completion
- 17 Dec 2023 (estimated)
- Study completion
- 17 Jun 2024 (estimated)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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]).
| Arm | Type | Receives |
|---|---|---|
| Single Intervention Study Arm | Experimental | Other: New York Heart Association Classification GuideAll 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New York Heart Association Classification GuideThe New York Heart Association Classification Guide is a questionnaire that assists in guiding the provider in selection of the patient's class | Other | Single Intervention Study Arm |
Primary outcome
Reliability of the New York Heart Association (NYHA) Classification Guide
Time frame: 12 weeks
Experts will assign NYHA class using the guide in 30 selected clinical records. The assigned class results will be compared to determine reliability.
Validity of the New York Heart Association (NYHA) Classification Guide
Time frame: 1 year
Providers will assign NYHA class using the guide to assess participants with HF who will then perform a 6-minute walk test.
Barriers to implementation of the New York Heart Association (NYHA) Classification Guide
Time frame: 30-days
Providers will be surveyed following 30-days of using the NYHA Classification Guide in the clinical setting regarding perceived barriers to implementation into practice.
Facilitators to implementation of the New York Heart Association (NYHA) Classification Guide
Time frame: 30-days
Providers will be surveyed following 30-days of using the NYHA Classification Guide in the clinical setting regarding perceived facilitators to implementation into practice.
Documentation after Implementation of the New York Heart Association (NYHA) Classification Guide
Time frame: 60-days
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Providers' Accuracy in Decision-Making with Assessing NYHA Functional Class of Patients with Heart Failure after use of a Classification GuideLink provided by the sponsor.
- Providers' assignment of NYHA functional class in patients with heart failure: A vignette studyLink provided by the sponsor.
- Individual participant dataSharing planned: No. Aggregate data will be published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marilyn A. Prasun, PhD principal investigator
Board of Trustees of Illinois State University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New York Heart Association Classification Guide in people with Heart Failure and Heart Failure With Reduced Ejection Fraction, run by Board of Trustees of Illinois State University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marilyn A. Prasun, PhD (217-433-2316, maprasu@ilstu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability of the New York Heart Association (NYHA) Classification Guide (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.