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
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Fujian Medical University
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- 6-Minute Walk Test
Overview
Brief Summary
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.
Detailed Description
- Study Design This is a prospective, single-center, randomized controlled clinical trial designed to evaluate the efficacy and safety of hyperbaric oxygen therapy as an adjunctive treatment for chronic heart failure.
- Randomization After confirming eligibility, participants will be randomized in a 1:1 ratio via a web-based randomization system into either the experimental group (hyperbaric oxygen therapy plus standard medication) or the control group (standard medication alone).
- Treatment Protocol Patients diagnosed with chronic heart failure at the center, who meet the criteria and have no absolute contraindications for hyperbaric oxygen therapy, will be enrolled. Specifically, the study will enroll patients with Heart Failure with Reduced Ejection Fraction (HFrEF, EF ≤40%) as per the latest guidelines.
Experimental Group: Participants will receive hyperbaric oxygen therapy in addition to stable, guideline-directed medical therapy based on the "New Four Pillars" (ARNI/ACEI/ARB + Beta-blocker + MRA + SGLT2 inhibitor).
Control Group: Participants will receive only the standard guideline-directed medical therapy ("New Four Pillars" as above) for chronic heart failure. All other aspects of care are identical to the experimental group, except for the hyperbaric oxygen therapy.
Given that chronic heart failure requires long-term management, the hyperbaric oxygen protocol is divided into three courses to consolidate and maintain efficacy, as well as to improve patients' oxygen reserve capacity and tolerance. Each course consists of 10 sessions, with a one-month interval between courses.
The hyperbaric oxygen treatment will be administered in a multi-place chamber at a pressure of 0.2 MPa (2 ATA). The session protocol 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. Sessions are conducted 5 times per week, making the total duration of each treatment course 14 days. 4. Follow-up After randomization and initiation of treatment, clinical follow-up visits will be conducted to collect data. For the experimental group, follow-ups will occur one day after the completion of each hyperbaric oxygen course. All participants (both groups) will undergo additional follow-ups at 3 months, 6 months, and 12 months after the complete hyperbaric oxygen treatment regimen.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnostic Criteria
- •Diagnosis of chronic heart failure according to the Chinese Guidelines for the Diagnosis and Management of Heart Failure (2024), and meeting the following conditions:
- •1.1 Left Ventricular Ejection Fraction (LVEF) ≤ 40% (HFrEF group). 1.2 Presence of chronic HF symptoms (NYHA functional class II-IV) or objective evidence (e.g., elevated natriuretic peptides, structural cardiac abnormalities).
- •1.3 Disease duration ≥ 3 months, with no adjustments to the foundational anti-heart failure regimen within the past month.
- •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.
- •3.2 No diuretic dose adjustments within the past 5 days and no clinical signs of fluid overload (e.g., weight gain of ≥ 2 kg/week, new-onset pulmonary edema).
Exclusion Criteria
- •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.
- •Concurrent intracranial hemorrhage, intracranial mass, malignant tumor, uncontrolled epilepsy, psychiatric disorder, coagulation dysfunction, or other severe uncontrolled comorbidities.
- •Severe pulmonary bullae or emphysema.
- •Active internal bleeding or coagulopathy.
- •Uncontrolled hyperpyrexia (body temperature \>38.0°C).
- •Concurrent use of disulfiram, bleomycin, or cisplatin chemotherapy. Relative Contraindications
- •Uncontrolled hypertension (systolic BP \>160 mmHg or diastolic BP \>100 mmHg).
Outcomes
Primary Outcomes
6-Minute Walk Test
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.
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(Echocardiograms will be performed at baseline, following each HBOT course (1-day), and at 3, 6, and 12-month follow-ups.)
- Non-Invasive Cardiac Output Monitoring(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.)
- Cardiopulmonary Exercise Testing (CPET)(CPET will be performed at baseline, 1-day post-each HBOT course, and at 3/6/12-month follow-ups.)
- Kansas City Cardiomyopathy Questionnaire(KCCQ will be administered at baseline, 1-day post-each HBOT course, and during 3/6/12-month follow-ups.)
- Meta-Analysis Global Group in Chronic Heart Failure(The MAGGIC risk score will be calculated at baseline, one day after each hyperbaric oxygen treatment course, and at 3, 6, and 12 months post-treatment.)
- Pittsburgh Sleep Quality Index (PSQI)(PSQI will be administered at baseline, 1-day post-each HBOT course, and during 3/6/12-month follow-ups.)
Investigators
Liang-Wan Chen MD
Chief
Fujian Medical University