Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT05223751
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05223751
Study Brief:
Protocol Section:
NCT05223751