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Respiratory Training for Heart Failure (PART-HF Trial)

N/A
Waitlist Available
Led By Roy Small, MD
Research Sponsored by Lancaster General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years or older
NYHA class II-III heart failure
Must not have
Neuromuscular disease which impairs respiration
Unable or unwilling to complete respiratory training protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months
Awards & highlights

Summary

This trial tests a breathing therapy for heart failure patients with reduced heart function. The therapy includes using a breathing app and coaching to improve respiratory function and heart health.

Who is the study for?
This trial is for adults with NYHA class II or III heart failure and an Ejection Fraction (EF) of 45% or less. Participants must have been on a stable medical regimen for at least 30 days, be likely to follow the breathing training, have a smartphone with internet, and be under care at Lancaster General Health Penn Medicine.
What is being tested?
The study compares standard heart failure care to an added breathing therapy involving Stasis Breathing and humming exercises. It's designed to see if these exercises can help improve symptoms in patients with reduced heart function.
What are the potential side effects?
Since this trial involves non-invasive breathing exercises, side effects may include discomfort from the training protocol or possible fatigue due to exertion during respiratory training.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have moderate heart failure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a muscle condition that affects my breathing.
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I cannot or do not want to follow a breathing exercise program.
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I have severe heart failure that severely limits my daily activities.
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I have severe COPD.
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I have severe sleep apnea that hasn't been treated.
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My heart often beats faster than 100 beats per minute.
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I have physical limitations that prevent me from walking for 6 minutes.
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I have had a paralyzed diaphragm.
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I have severe heart valve disease.
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I have been diagnosed with a cognitive impairment that prevents me from participating in training.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline to 6 months for the 6-minute walk test (6MWT)
Secondary study objectives
Kansas City Cardiomyopathy Questionnaire 12 (KCCQ12) quality of life score
New York Heart Association (NYHA) Class (graded I-IV) Proportion Improved 1 Class
Pulmonary parameters: Peak expiratory flow

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: HRV4 + Breathing and Humming TrainingExperimental Treatment1 Intervention
On a biweekly basis, and with the other members of their subgroup within the cohort, participants will meet with the Meo Health breathing coach on Zoom for approximately 30 minutes. These sessions will encourage participants to complete their daily exercises and provide additional respiratory training.
Group II: HRV4 OnlyActive Control1 Intervention
Control participants will complete the daily heart rate variability (HRV) reading using the HRV4Training application.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Heart Failure (HF) aim to improve cardiac function, reduce symptoms, and enhance quality of life. Treatments like breathing therapy focus on improving respiratory muscle strength, enhancing oxygenation, and reducing the work of breathing. By strengthening respiratory muscles, patients can breathe more efficiently, which helps in better oxygen delivery to tissues. Enhanced oxygenation ensures that vital organs receive adequate oxygen, reducing the strain on the heart. Reducing the work of breathing decreases the overall energy expenditure, allowing the heart to function more effectively. These mechanisms are crucial for HF patients as they help alleviate symptoms, improve exercise tolerance, and potentially reduce hospitalizations.

Find a Location

Who is running the clinical trial?

Lancaster General HospitalLead Sponsor
23 Previous Clinical Trials
3,903 Total Patients Enrolled
4 Trials studying Heart Failure
1,032 Patients Enrolled for Heart Failure
Louise von Hess Medical Research InstituteOTHER
3 Previous Clinical Trials
263 Total Patients Enrolled
Roy Small, MDPrincipal InvestigatorMedical Director
1 Previous Clinical Trials
3 Total Patients Enrolled
1 Trials studying Heart Failure
3 Patients Enrolled for Heart Failure

Media Library

Stasis Breathing and Humming Exercises Clinical Trial Eligibility Overview. Trial Name: NCT05223751 — N/A
Heart Failure Research Study Groups: HRV4 + Breathing and Humming Training, HRV4 Only
Heart Failure Clinical Trial 2023: Stasis Breathing and Humming Exercises Highlights & Side Effects. Trial Name: NCT05223751 — N/A
Stasis Breathing and Humming Exercises 2023 Treatment Timeline for Medical Study. Trial Name: NCT05223751 — N/A
~13 spots leftby Feb 2025
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