Parasympathetic Augmentation Via Respiratory Training for Patients With Systolic Heart Failure
Reason given: Enrollment goal was not reached within the allotted funding period.
Key facts
- Where
- Lancaster, United StatesSee the site
Where in United States
- Lancaster General HospitalLancaster, United StatesNo longer taking part
Trial details
- Who runs it
- Lancaster General Hospital
- Trial code
- NCT05223751
- Record updated
- 23 October 2025
- Original description
This is a prospective, randomized, controlled clinical trial in which participants with NYHA class II or III and symptomatic Heart Failure with reduced Ejection Fraction (HFrEF) (Ejection Fraction (EF) ≤ 45%) will be assigned to one of two treatment groups: standard of care or breathing therapy.Read full original descriptionShow less
This is a prospective, randomized, controlled clinical trial in which participants with NYHA class II or III and symptomatic Heart Failure with reduced Ejection Fraction (HFrEF) (Ejection Fraction (EF) ≤ 45%) will be assigned to one of two treatment groups: standard of care or breathing therapy.
Inclusion: 18 years or older; Signed informed consent; NYHA class II-III heart failure; EF ≤ 45% (echo within 1 year of enrollment); At least 30 days of stable medical regimen (no new neurohormonal blockade or Sodium-glucose co-transporter 2 inhibitors (SGLT2i). Dose adjustments allowed); Likely to be compliant with breath training as assessed by the provider; Availability of a "smart" phone and internet access; Established care at Lancaster General Health Penn Medicine.
Exclusion: Prior or planned chest/abdominal or nasal/facial surgery within 6 months; Cardiac resynchronization therapy (CRT) within 6 months; Severe Chronic obstructive pulmonary disease (COPD); History of diaphragm paralysis; Decompensated or American College of Cardiology (ACC) Stage D Heart Failure (HF); Neuromuscular disease which impairs respiration; Diagnosed cognitive impairment (unable to participate in training); Severe valvular heart disease; Uncontrolled atrial fibrillation (Ave Heart Rate (HR) > 100 bpm); Unable or unwilling to complete respiratory training protocol; Untreated obstructive severe sleep apnea (AHI > 30); Orthopedic or other limitations which impair the 6-minute walk test.