Status:
TERMINATED
Parasympathetic Augmentation Via Respiratory Training for Patients With Systolic Heart Failure
Lead Sponsor:
Lancaster General Hospital
Collaborating Sponsors:
Louise von Hess Medical Research Institute
Conditions:
Diastolic Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
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...
Eligibility Criteria
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
- 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
- Neuromuscular disease which impairs respiration
- Diagnosed cognitive impairment (unable to participate in training)
- Untreated obstructive severe sleep apnea (AHI \> 30)
- Severe valvular heart disease
- Uncontrolled atrial fibrillation (Ave Heart Rate (HR) \> 100 bpm)
- Orthopedic or other limitations which impair the 6-minute walk test
Key Trial Info
Start Date :
February 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 12 2025
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT05223751
Start Date
February 7 2022
End Date
September 12 2025
Last Update
October 23 2025
Active Locations (1)
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1
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17604