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

NCT07311109 | Not Yet Recruiting

• 1 other identifier: A0202502
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Heart Failure With Reduced Ejection Fraction

Keywords

chronic heart failure; HBOT

Outcome Measures

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).

  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 (6)

• 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.

• Cardiopulmonary Exercise Testing (CPET)

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

• 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.

Study Arms (2)

hyperbaric oxygen therapy

EXPERIMENTAL

Participants in the control arm will receive guideline-directed medical therapy exclusively, founded on the "New Four Pillars" regimen (ARNI/ACEI/ARB + Beta-blocker + MRA + SGLT2 inhibitor) for chronic heart failure. The hyperbaric oxygen therapy protocol consists of 3 treatment courses, with each course comprising 10 sessions. There is a one-month interval between each course. 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. Sessions are conducted 5 times per week, making the total duration of each treatment course 14 days.

Other: hyperbaric oxygen therapy

standard guideline-directed medical therapy for chronic heart failure

SHAM COMPARATOR

Participants in the control arm will receive guideline-directed medical therapy exclusively, founded on the "New Four Pillars" regimen (ARNI/ACEI/ARB + Beta-blocker + MRA + SGLT2 inhibitor) for chronic heart failure. Apart from the absence of hyperbaric oxygen therapy, all other management strategies are consistent with those in the experimental arm.

Other: hyperbaric oxygen therapy

Interventions

hyperbaric oxygen therapy OTHER

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.

hyperbaric oxygen therapy; standard guideline-directed medical therapy for chronic heart failure

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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).
• 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.
• 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).

You may not qualify if:

• 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).
• Severe cardiac arrhythmias (e.g., third-degree atrioventricular block without a pacemaker, frequent ventricular tachycardia).
• Chronic obstructive pulmonary disease (FEV1 \<50% of predicted) or active asthma.
• Psychiatric or cognitive impairment preventing cooperation with the therapy. Comorbidity Restrictions
• End-stage renal disease (dialysis-dependent).
• Terminal malignancy (life expectancy \<6 months).

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Location

MeSH Terms

Interventions

Hyperbaric Oxygenation

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Central Study Contacts

Hanyu Wang, Master's Degree

CONTACT

+86 18359185713; 599041012@qq.com

Liangwan Chen, M.D.Ph.D

CONTACT

+86 13358255333; chenliangwan@fjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 30, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)