Parasympathetic Augmentation Via Respiratory Training for Patients With Systolic Heart Failure (NCT05223751) | Clinical Trial Compass
TerminatedNot Applicable
Parasympathetic Augmentation Via Respiratory Training for Patients With Systolic Heart Failure
Stopped: Enrollment goal was not reached within the allotted funding period.
United States65 participantsStarted 2022-02-07
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. Cardiac resynchronization therapy (CRT) within 6 months
✕. Severe Chronic obstructive pulmonary disease (COPD)
✕. History of diaphragm paralysis
✕. Unable or unwilling to complete respiratory training protocol
✕. Decompensated or American College of Cardiology (ACC) Stage D Heart Failure (HF)
✕. Prior or planned chest/abdominal or nasal/facial surgery within 6 months
What they're measuring
1
Change from baseline to 6 months for the 6-minute walk test (6MWT)