Respiratory Training for Heart Failure
(PART-HF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine whether Stasis Breathing and Humming Exercises can benefit individuals with heart failure who have a reduced ejection fraction (a measure of how much blood the heart pumps out). Participants will be divided into two groups: one will perform these exercises with guidance, while the other will only track their heart rate. Suitable candidates have heart failure with symptoms such as shortness of breath and have maintained stability on their current treatments for at least 30 days. Participants must have access to a smartphone and internet to join virtual sessions. As an unphased trial, this study provides a unique opportunity to explore innovative non-drug therapies for heart failure.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop your current medications, but you must have been on a stable medical regimen for at least 30 days before joining. This means no new medications like neurohormonal blockers or SGLT2 inhibitors, but dose adjustments are allowed.
What prior data suggests that these breathing exercises are safe for heart failure patients?
Research shows that breathing exercises, like those in this trial, are generally safe for people with heart failure. One study found that slow breathing exercises helped individuals with stable heart failure and reported no major safety issues. These exercises might also lower blood pressure and heart rate, benefiting heart health.
However, limited research exists specifically on mindfulness-based breathing exercises for heart failure patients. This indicates some unknowns, but no major safety concerns have emerged so far. Overall, breathing exercises are considered safe and can improve exercise ability and quality of life for heart failure patients.12345Why are researchers excited about this trial?
Researchers are excited about Stasis Breathing and Humming Exercises for heart failure because these techniques offer a non-pharmacological approach to managing the condition. Unlike standard treatments that often rely on medications like beta-blockers and ACE inhibitors, these exercises focus on enhancing heart health by improving respiratory function and heart rate variability through simple, daily practices. This approach could potentially empower patients with a more accessible and self-managed tool to support their heart health, reducing dependency on medication and improving quality of life.
What evidence suggests that breathing and humming exercises might be an effective treatment for heart failure?
Studies have shown that breathing exercises can positively affect blood pressure and heart rate, which is crucial for people with heart failure, as managing these factors can improve their condition. In this trial, participants in the "HRV4 + Breathing and Humming Training" arm will perform specific breathing exercises, including stasis breathing and humming, to assess their impact on heart failure symptoms. Research also indicates that breathing exercises can reduce tiredness and enhance the quality of life for heart failure patients. For example, one study found that a mindfulness-based breathing program helped reduce symptoms like shortness of breath and dizziness. Overall, promising evidence suggests that these breathing exercises can help manage heart failure symptoms.12678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Enrollment/Baseline
Participants meet with the clinical research coordinator to review study details and sign informed consent. Randomization and baseline assessments are conducted.
Treatment
Participants receive either standard of care or breathing therapy. Intervention group receives training on Meo Health breathing therapy.
3 Month Assessment
Participants undergo assessments including NYHA class, KCCQ, respiratory rate, peak expiratory flow, and 6-minute walk test.
6 Month/Final Visit
Final assessments are conducted, including NT-proBNP, NYHA class, KCCQ, respiratory rate, peak expiratory flow, and 6-minute walk test.
9 Month Follow-up
Structured telephone survey to assess adherence and health outcomes for participants who received breathing training.
What Are the Treatments Tested in This Trial?
Interventions
- Stasis Breathing and Humming Exercises
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lancaster General Hospital
Lead Sponsor
Louise von Hess Medical Research Institute
Collaborator