[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053832":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":11,"responsibleParty":31,"collaborators":11,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":37,"acronym":38,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":42,"enrollmentInfo":43,"targetDuration":11,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":52,"overallStatus":57,"whyStopped":11,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":11},{"fullName":5,"class":6},"University Hospital, Strasbourg, France","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"PAH Patients Receiving Omega-3","EXPERIMENTAL",null,[13],"Dietary Supplement: OMega 3",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DIETARY_SUPPLEMENT","OMega 3","The investigational product is an oral nutritional supplement consisting of an optimized omega-3 fatty acid formulation derived from fish oil. Each hard capsule (hydroxypropyl methylcellulose, HPMC) contains 667 mg of combined eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), with a stoichiometric EPA:DHA ratio of 6:1.\n\nThe product is provided as transparent hard capsules intended for oral administration.\n\nDosage and administration:\n\nParticipants will receive a total of four capsules per day, administered as two capsules in the morning and two capsules in the evening, taken with meals to improve gastrointestinal tolerance and absorption. The total daily dose of omega-3 fatty acids is approximately 2.7 g.\n\nTreatment duration:\n\nThe intervention will be administered for a total duration of 12 weeks.",[9],[21],{"name":22,"affiliation":5,"role":23},"Marianne RIOU, MD","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":29,"email":30},"Sarah HUSTACHE","CONTACT","+33 3 88 11 54 15","00 33","dpidrci@chru-strasbourg.fr",{"type":32,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100053832","impact-of-an-optimized-omega-3-formulation-on-inflammation-and-endothelial-dysfunction-in-pulmonary-arterial-hypertension-100053832",false,"NCT07697235","Impact of an Optimized Omega-3 Formulation on Inflammation and Endothelial Dysfunction in Pulmonary Arterial Hypertension","OMEGA-PAH","Inclusion Criteria:\n\n* Men or women between the ages of 18 and 75;\n* Idiopathic, hereditary, drug-induced, or anorexigen-induced PAH, or PAH associated with connective tissue disease;\n* Stable PAH treatment for at least 90 days;\n* Subjects capable of understanding the objectives and risks associated with the study and of providing dated and signed informed consent;\n* Subjects enrolled in a health insurance plan;\n* Subjects who have signed an informed consent form;\n* For women of childbearing age: negative pregnancy test at the screening\u002Finclusion visit; effective contraception\\* throughout the study (recommended in PAH)\n\n  * Effective and accepted methods of contraception during the study (subject, partner): oral contraceptive pill, intrauterine device (IUD), condom (male or female). Patients who practice total abstinence do not need to use contraception.\n\nExclusion criteria:\n\n* Patients treated with Omacor®;\n* Daily consumption of fish oil or fish oil-based dietary supplements (omega-3);\n* Hypersensitivity or allergy to fish, shellfish, peanuts, soy, corn oil, or coconut oil;\n* Anticoagulant therapy at therapeutic doses;\n* Cardiac decompensation within the month prior to enrollment;\n* Other causes of pulmonary hypertension (groups 2, 3, 4, or 5);\n* Persistent atrial fibrillation (AF);\n* Left ventricular ejection fraction \\\u003C 45% on echocardiography;\n* Recent episode of pulmonary embolism, within the past 6 months;\n* Myocardial infarction or placement of a coronary stent within the month prior to enrollment;\n* eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²;\n* Malignant disease (not considered in remission);\n* Severe sepsis;\n* Participation in another clinical trial within the previous 3 months;\n* Subjects under legal guardianship, conservatorship, or curatorship","ALL","18 Years","75 Years",{"count":44,"type":45},22,"ESTIMATED","INTERVENTIONAL",[48],"NA","The objective of this research project is to evaluate the biological effects of long-chain omega-3 supplementation, administered in an optimized, high-purity formulation (EPA:DHA 6:1, \\>95% v\u002Fv), as an adjunct to standard-of-care treatment in patients with pulmonary arterial hypertension (PAH).\n\nThe expected results are confirmation in humans of our preliminary data, namely a beneficial effect on systemic inflammation and pulmonary endothelial dysfunction in PAH. If our hypothesis is confirmed, omega-3s could constitute a complementary nutritional approach to current PAH therapies, subsequently requiring validation through a larger-scale, randomized, controlled study.",[51],"PAH",[53,54,55,56],"pulmonary arterial hypertension","inflammation","peripheral circulating cells","omega-3","NOT_YET_RECRUITING","2026-07-08",{"date":60,"type":61},"2026-07-13","ACTUAL",{"date":63,"type":45},"2026-07",{"date":65,"type":45},"2030-03",{"name":5,"class":6}]