About this trial
This study aims to investigate whether adjunctive hyperbaric oxygen therapy, compared to guideline-directed medical therapy with the "New Four Pillars" (ARNI/ACEI/ARB + β-blocker + MRA + SGLT2 inhibitor) alone, improves cardiac function in patients with chronic heart failure, and to evaluate its efficacy and safety.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnostic Criteria
Age and Informed Consent 2.1 Aged 18 to 70 years (inclusive). 2.2 Understand the study purpose and provide signed informed consent.
Treatment Stability 3.1 Received guideline-recommended, standardized "New Four Pillars" anti-heart failure therapy (ARNI/ACEI/ARB + β-blocker + MRA + SGLT2 inhibitor) for at least 2 weeks prior to enrollment, with no changes in the past month.
Disqualifiers
Absolute Contraindications
Untreated pneumothorax or pneumomediastinum.
Claustrophobia, agitation or inability to cooperate, or conditions unsuitable for HBOT such as angle-closure glaucoma or eustachian tube occlusion.
Unstable vital signs.
Trial design
Parallel
Treatments tested in this trial
hyperbaric oxygen therapy
Other interventionThe therapy is administered in a multi-place chamber at a pressure of 0.2 MPa (2 ATA). The treatment protocol per session is as follows: 20 minutes of compression, followed by two 30-minute periods of oxygen inhalation via mask, separated by a 10-minute air break, and finally 20 minutes of decompression. The total duration per session is 110 minutes.
Treatment groups
Trial outcomes
Primary outcomes
6-Minute Walk Test
The 6MWT is conducted on a 30-meter, flat corridor. Patients walk back and forth as far as possible in 6 minutes. They self-pace and can stop if needed. Standardized encouragement is given. Before and after, vital signs, dyspnea, and fatigue (Borg scale) are recorded. The primary outcome is the total distance walked (6MWD).
Secondary outcomes
Cardiac Color Doppler Ultrasound
During the test, the patient lies on their left side. A technician places a transducer with gel on the chest to obtain ultrasound images of the heart. It captures real-time images of chamber size, muscle thickness, valve motion, and pumping function (ejection fraction). The procedure is painless, takes about 30-45 minutes, and requires no special preparation.
Cardiopulmonary Exercise Testing (CPET)
Cardiopulmonary Exercise Testing (CPET) measures how the heart, lungs, and muscles work during exercise. The patient exercises on a treadmill or stationary bike with increasing intensity while wearing a mask to analyze oxygen and carbon dioxide. Vital signs are monitored throughout. The test lasts 10-15 minutes and evaluates overall cardiopulmonary fitness.
Non-Invasive Cardiac Output Monitoring
Non-Invasive Cardiac Output Monitoring (NICOM) measures heart function without inserting catheters. Electrode sensors are placed on the patient's chest to track blood flow dynamics using bioimpedance or bioreactance technology. The patient remains still during the 10-20 minute test, which provides real-time data on cardiac output and stroke volume. No special preparation is required.
Kansas City Cardiomyopathy Questionnaire
The KCCQ is a self-administered questionnaire. Patients answer 23 items about their heart failure symptoms and how it impacts their life over the past 2 weeks. It takes about 5-10 minutes to complete and produces scores from 0-100, where higher scores indicate better health status and quality of life.
Sponsors and contacts
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