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NYHA Classification Guide for Heart Failure (CLASS-HF Trial)

N/A

Recruiting

Led By Marilyn A. Prasun, PhD

Research Sponsored by Board of Trustees of Illinois State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A documented confirmed diagnosis of Heart Failure (HF)

Ability to walk without assistance

Must not have

Active endocarditis

Diagnosed with myocardial infarction, coronary artery bypass graft (CABG), angioplasty or stent in the previous 30-days

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how well a classification guide helps healthcare providers treat heart failure patients. They will compare patient results from the guide to a standardized test. Then they will use the guide in a clinic setting to see how healthcare providers perceive it.

Who is the study for?

Adults aged 18-90 with confirmed heart failure, able to walk unassisted and communicate in English. They must be under a cardiologist's care, oriented, and not have conditions like uncontrolled high blood pressure or recent severe cardiac events.

What is being tested?

The trial is examining the New York Heart Association Classification Guide used by healthcare providers to assess heart failure severity. It involves comparing this guide's results with a standard 6-minute walk test and evaluating its use over 30 days in clinical practice.

What are the potential side effects?

Since this study focuses on assessment methods rather than medications or invasive treatments, there are no direct side effects from interventions being tested.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been officially diagnosed with Heart Failure.

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I can walk on my own without help.

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I am between 18 and 89 years old.

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I am aware of who I am, where I am, and the current time.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an ongoing heart infection.

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I had a heart attack or heart surgery in the last 30 days.

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My asthma is not well-managed.

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I am suspected to have a type of aneurysm that splits the layers of my artery wall.

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I have had a heart shock treatment due to irregular heartbeat in the last month.

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I have inflammation of the heart or its surrounding tissues.

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I have an irregular heartbeat that is not under control.

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I have fluid in my lungs.

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I am experiencing severe breathing problems.

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I have severe symptoms from a narrowed heart valve.

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I have a lung clot or lung infection.

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I am able to understand and follow study procedures.

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I have had blood clots in my legs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Barriers to implementation of the New York Heart Association (NYHA) Classification Guide

Documentation after Implementation of the New York Heart Association (NYHA) Classification Guide

Facilitators to implementation of the New York Heart Association (NYHA) Classification Guide

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single Intervention Study ArmExperimental Treatment1 Intervention

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.

0 / 17Eligibility criteria met