Parasympathetic Augmentation Via Respiratory Training for Patients With Systolic Heart Failure

Launched by LANCASTER GENERAL HOSPITAL · Jan 25, 2022

Keywords

ClinConnect Summary

To evaluate the effect of breathing training on the 6-minute walk test in a population of heart failure patients.

Enrollment/Baseline Visit During the enrollment visit, the participant will meet with the clinical research coordinator (CRC) to review any final questions regarding the study and the informed consent form will be signed. The enrollment visit must occur within one month of screening. Once the informed consent is signed, the following procedures will occur.

* Randomization: Participants will be randomized using REDCap in a 2:1 blocking method into the intervention group (breath...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 18 years or older
• • 2. Signed informed consent
• • 3. NYHA class II-III heart failure
• • 4. EF ≤ 45% (echo within 1 year of enrollment)
• • 5. At least 30 days of stable medical regimen (no new neurohormonal blockade or Sodium-glucose co-transporter 2 inhibitors (SGLT2i). Dose adjustments allowed)
• • 6. Likely to be compliant with breath training as assessed by the provider
• • 7. Availability of a "smart" phone and internet access
• • 8. Established care at Lancaster General Health Penn Medicine
• Exclusion Criteria:
• • 1. Cardiac resynchronization therapy (CRT) within 6 months
• • 2. Severe Chronic obstructive pulmonary disease (COPD)
• • 3. History of diaphragm paralysis
• • 4. Unable or unwilling to complete respiratory training protocol
• • 5. Decompensated or American College of Cardiology (ACC) Stage D Heart Failure (HF)
• • 6. Prior or planned chest/abdominal or nasal/facial surgery within 6 months
• • 7. Neuromuscular disease which impairs respiration
• • 8. Diagnosed cognitive impairment (unable to participate in training)
• • 9. Untreated obstructive severe sleep apnea (AHI \> 30)
• • 10. Severe valvular heart disease
• • 11. Uncontrolled atrial fibrillation (Ave Heart Rate (HR) \> 100 bpm)
• • 12. Orthopedic or other limitations which impair the 6-minute walk test