What side effects are associated with this type of intervention?

Common treatments for heart failure include medications such as ACE inhibitors, beta-blockers, and diuretics, which can cause side effects like cough, dizziness, electrolyte imbalances, and fatigue. Non-pharmacological interventions similar to breathing therapy, such as respiratory training and pulmonary rehabilitation, are generally well-tolerated but may cause mild muscle soreness, fatigue, or shortness of breath during initial sessions. It is important to monitor these side effects and adjust the therapy as needed under medical supervision.

What prior FDA approvals exist?

FDA-approved treatments for heart failure primarily include medications such as ACE inhibitors, beta-blockers, diuretics, and aldosterone antagonists, which help manage symptoms and improve heart function. While these medications do not directly target respiratory muscle strength or oxygenation, they can indirectly improve breathing by reducing fluid overload and improving cardiac output. Additionally, devices like CPAP (Continuous Positive Airway Pressure) are used to enhance oxygenation and reduce the work of breathing in heart failure patients with sleep apnea. However, specific FDA-approved treatments that directly improve respiratory muscle strength in heart failure patients are limited.

What other types of research exist?

Promising novel alternatives to breathing therapy for heart failure patients include noninvasive ventilatory support, mechanical insufflation-exsufflation, and diaphragm pacing. These methods can improve respiratory muscle strength, enhance oxygenation, and reduce the work of breathing.

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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months, 6 months

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

Awards & Highlights

No Placebo-Only Group

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

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.

0 / 12Eligibility criteria met

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.