A Prospective, Single-center, Randomized Controlled Clinical Study Evaluating the Efficacy and Safety of Hyperbaric Oxygen Therapy as an Adjunctive Treatment for Chronic Heart Failure

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorFujian Medical University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • hyperbaric oxygen therapy

    Other intervention

    The 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

150 Participants
are divided into 2 treatment groups
Group A: hyperbaric oxygen therapyExperimental treatment 1 intervention
Group B: standard guideline-directed medical therapy for chronic heart failureSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
6MWT will be performed in the experimental group at baseline (pre-HBOT), one day after each HBOT course, and at 3, 6, and 12 months post-treatment.

Secondary outcomes

1

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.

Time frame
Echocardiograms will be performed at baseline, following each HBOT course (1-day), and at 3, 6, and 12-month follow-ups.
2

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.

Time frame
CPET will be performed at baseline, 1-day post-each HBOT course, and at 3/6/12-month follow-ups.
3

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.

Time frame
Non-Invasive Cardiac Output Monitoring (NICOM) results will be recorded at baseline, one day after each hyperbaric oxygen treatment course, and at 3, 6, and 12 months post-treatment.
4

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.

Time frame
KCCQ will be administered at baseline, 1-day post-each HBOT course, and during 3/6/12-month follow-ups.

Other outcomes

Sponsors and contacts

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