Respiratory Training for Heart Failure

(PART-HF Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lancaster General Hospital

Disqualifiers: Severe COPD, Diaphragm paralysis, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 6 months

114 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 on the Research Team?

Roy Small, MD

Principal Investigator

Medical Director

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Signed informed consent

My medication has been stable for at least 30 days without starting new heart or diabetes drugs.

I have moderate heart failure.

Exclusion Criteria

I have a muscle condition that affects my breathing.

I have had a heart device implanted within the last 6 months.

I cannot or do not want to follow a breathing exercise program.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment/Baseline

Participants meet with the clinical research coordinator to review study details and sign informed consent. Randomization and baseline assessments are conducted.

1 month

1 visit (in-person)

Treatment

Participants receive either standard of care or breathing therapy. Intervention group receives training on Meo Health breathing therapy.

6 months

Biweekly Zoom sessions for intervention group

3 Month Assessment

Participants undergo assessments including NYHA class, KCCQ, respiratory rate, peak expiratory flow, and 6-minute walk test.

3 months

1 visit (in-person)

6 Month/Final Visit

Final assessments are conducted, including NT-proBNP, NYHA class, KCCQ, respiratory rate, peak expiratory flow, and 6-minute walk test.

6 months

1 visit (in-person)

9 Month Follow-up

Structured telephone survey to assess adherence and health outcomes for participants who received breathing training.

9 months

1 call (telephone)

What Are the Treatments Tested in This Trial?

Interventions

• Stasis Breathing and Humming Exercises

Trial Overview 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.

How Is the Trial Designed?

Group I: HRV4 + Breathing and Humming Training Experimental Treatment 1 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 Only Active Control 1 Intervention

Control participants will complete the daily heart rate variability (HRV) reading using the HRV4Training application.

Who Is Running the Clinical Trial?

Lancaster General Hospital

Lead Sponsor

Trials

25

Recruited

4,100+

Louise von Hess Medical Research Institute

Collaborator

Trials

4

Recruited

380+