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Can oxygen chambers boost heart failure treatment?

NCT ID NCT07311109

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Recruiting now
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Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
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Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether adding hyperbaric oxygen therapy (breathing pure oxygen in a pressurized chamber) to standard heart failure medications can help people with chronic heart failure walk farther and improve heart function. About 150 adults with reduced heart pumping ability will be randomly assigned to receive either standard drugs alone or standard drugs plus oxygen sessions. The main goal is to see if the oxygen therapy safely increases walking distance in six minutes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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. 2. Age and Informed Consent 2.1 Aged 18 to 70 years (inclusive). 2.2 Understand the study purpose and provide signed informed consent. 3. 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 1. Untreated pneumothorax or pneumomediastinum. 2. Claustrophobia, agitation or inability to cooperate, or conditions unsuitable for HBOT such as angle-closure glaucoma or eustachian tube occlusion. 3. Unstable vital signs. 4. Concurrent intracranial hemorrhage, intracranial mass, malignant tumor, uncontrolled epilepsy, psychiatric disorder, coagulation dysfunction, or other severe uncontrolled comorbidities. 5. Severe pulmonary bullae or emphysema. 6. Active internal bleeding or coagulopathy. 7. Uncontrolled hyperpyrexia (body temperature \>38.0°C). 8. Concurrent use of disulfiram, bleomycin, or cisplatin chemotherapy. Relative Contraindications 9. Uncontrolled hypertension (systolic BP \>160 mmHg or diastolic BP \>100 mmHg). 10. Severe cardiac arrhythmias (e.g., third-degree atrioventricular block without a pacemaker, frequent ventricular tachycardia). 11. Chronic obstructive pulmonary disease (FEV1 \<50% of predicted) or active asthma. 12. Psychiatric or cognitive impairment preventing cooperation with the therapy. Comorbidity Restrictions 13. End-stage renal disease (dialysis-dependent). 14. Terminal malignancy (life expectancy \<6 months). 15. Pregnancy or lactation (a negative pregnancy test is required for women of childbearing potential). Recent Clinical Events 16. Acute myocardial infarction or unstable angina within the past 4 weeks. 17. Hospitalization or emergency department visit for acute heart failure within the past 2 weeks. 18. Current use of intravenous positive inotropic agents. 19. Within 6 months after cardiac surgery. 20. Use of any mechanical circulatory support. 21. Participants with a 6-minute walk test result exceeding 450 meters or who are unable to complete the test. Other Exclusion Conditions 22. Inability to complete follow-up (e.g., planned relocation, non-compliance with follow-up assessments). 23. Concurrent participation in any other clinical trial that may interfere with the outcomes of this study. 24. Unforeseen circumstances judged by the investigators to be ineligible.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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Contacts and locations

Locations

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, China

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Other studies related to the condition(s) this trial covers.