[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616861":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":23,"centralContacts":24,"locations":34,"responsibleParty":51,"collaborators":23,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":23,"eligibilityCriteria":60,"healthyVolunteers":57,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":23,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":76,"whyStopped":23,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Fujian Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"hyperbaric oxygen therapy","EXPERIMENTAL","Participants in the control arm will receive guideline-directed medical therapy exclusively, founded on the \"New Four Pillars\" regimen (ARNI\u002FACEI\u002FARB + Beta-blocker + MRA + SGLT2 inhibitor) for chronic heart failure.\n\nThe hyperbaric oxygen therapy protocol consists of 3 treatment courses, with each course comprising 10 sessions. There is a one-month interval between each course.\n\nThe 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.\n\nSessions are conducted 5 times per week, making the total duration of each treatment course 14 days.",[13],"Other: hyperbaric oxygen therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"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\u002FACEI\u002FARB + 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.",[13],[20],{"type":6,"name":9,"description":21,"armGroupLabels":22,"otherNames":23},"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.",[9,15],null,[25,30],{"name":26,"role":27,"phone":28,"phoneExt":23,"email":29},"Hanyu Wang, Master's Degree","CONTACT","+86 18359185713","599041012@qq.com",{"name":31,"role":27,"phone":32,"phoneExt":23,"email":33},"Liangwan Chen, M.D.Ph.D","+86 13358255333","chenliangwan@fjmu.edu.cn",[35],{"facility":36,"status":23,"city":37,"state":38,"zip":23,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Fujian Medical University Union Hospital","Fuzhou","Fujian","China","CN",{"type":42,"coordinates":43},"Point",[44,45],119.30611,26.06139,{"lat":45,"lon":44},[48,50],{"name":49,"role":27,"phone":32,"phoneExt":23,"email":33},"Liangwan Chen, Master's Degree",{"name":31,"role":27,"phone":32,"phoneExt":23,"email":23},{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Liang-Wan Chen MD","Chief","100616861","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-100616861",false,"NCT07311109","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","Inclusion Criteria:\n\n1. Diagnostic Criteria\n\n   Diagnosis of chronic heart failure according to the Chinese Guidelines for the Diagnosis and Management of Heart Failure (2024), and meeting the following conditions:\n\n   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).\n\n   1.3 Disease duration ≥ 3 months, with no adjustments to the foundational anti-heart failure regimen within the past month.\n2. Age and Informed Consent 2.1 Aged 18 to 70 years (inclusive). 2.2 Understand the study purpose and provide signed informed consent.\n3. Treatment Stability 3.1 Received guideline-recommended, standardized \"New Four Pillars\" anti-heart failure therapy (ARNI\u002FACEI\u002FARB + β-blocker + MRA + SGLT2 inhibitor) for at least 2 weeks prior to enrollment, with no changes in the past month.\n\n3.2 No diuretic dose adjustments within the past 5 days and no clinical signs of fluid overload (e.g., weight gain of ≥ 2 kg\u002Fweek, new-onset pulmonary edema).\n\n\\-\n\nExclusion Criteria:\n\n* Absolute Contraindications\n\n  1. Untreated pneumothorax or pneumomediastinum.\n  2. Claustrophobia, agitation or inability to cooperate, or conditions unsuitable for HBOT such as angle-closure glaucoma or eustachian tube occlusion.\n  3. Unstable vital signs.\n  4. Concurrent intracranial hemorrhage, intracranial mass, malignant tumor, uncontrolled epilepsy, psychiatric disorder, coagulation dysfunction, or other severe uncontrolled comorbidities.\n  5. Severe pulmonary bullae or emphysema.\n  6. Active internal bleeding or coagulopathy.\n  7. Uncontrolled hyperpyrexia (body temperature \\>38.0°C).\n  8. Concurrent use of disulfiram, bleomycin, or cisplatin chemotherapy. Relative Contraindications\n  9. Uncontrolled hypertension (systolic BP \\>160 mmHg or diastolic BP \\>100 mmHg).\n  10. Severe cardiac arrhythmias (e.g., third-degree atrioventricular block without a pacemaker, frequent ventricular tachycardia).\n  11. Chronic obstructive pulmonary disease (FEV1 \\\u003C50% of predicted) or active asthma.\n  12. Psychiatric or cognitive impairment preventing cooperation with the therapy. Comorbidity Restrictions\n  13. End-stage renal disease (dialysis-dependent).\n  14. Terminal malignancy (life expectancy \\\u003C6 months).\n  15. Pregnancy or lactation (a negative pregnancy test is required for women of childbearing potential).\n\n      Recent Clinical Events\n  16. Acute myocardial infarction or unstable angina within the past 4 weeks.\n  17. Hospitalization or emergency department visit for acute heart failure within the past 2 weeks.\n  18. Current use of intravenous positive inotropic agents.\n  19. Within 6 months after cardiac surgery.\n  20. Use of any mechanical circulatory support.\n  21. Participants with a 6-minute walk test result exceeding 450 meters or who are unable to complete the test.\n\n      Other Exclusion Conditions\n  22. Inability to complete follow-up (e.g., planned relocation, non-compliance with follow-up assessments).\n  23. Concurrent participation in any other clinical trial that may interfere with the outcomes of this study.\n  24. Unforeseen circumstances judged by the investigators to be ineligible.","ALL","18 Years","70 Years",{"count":65,"type":66},150,"ESTIMATED","INTERVENTIONAL",[69],"NA","This study aims to investigate whether adjunctive hyperbaric oxygen therapy, compared to guideline-directed medical therapy with the \"New Four Pillars\" (ARNI\u002FACEI\u002FARB + β-blocker + MRA + SGLT2 inhibitor) alone, improves cardiac function in patients with chronic heart failure, and to evaluate its efficacy and safety.",[72],"Chronic Heart Failure With Reduced Ejection Fraction",[74,75],"chronic heart failure","HBOT","NOT_YET_RECRUITING","2025-12-16",{"date":79,"type":80},"2025-12-30","ACTUAL",{"date":82,"type":66},"2025-12-15",{"date":84,"type":66},"2028-12-31",{"name":5,"class":6},1]