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/v), as an adjunct to standard-of-care treatment in patients with pulmonary arterial hypertension (PAH).
The 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.
Men or women between the ages of 18 and 75;
Idiopathic, hereditary, drug-induced, or anorexigen-induced PAH, or PAH associated with connective tissue disease;
Stable PAH treatment for at least 90 days;
Subjects capable of understanding the objectives and risks associated with the study and of providing dated and signed informed consent;
Patients treated with Omacor®;
Daily consumption of fish oil or fish oil-based dietary supplements (omega-3);
Hypersensitivity or allergy to fish, shellfish, peanuts, soy, corn oil, or coconut oil;
Anticoagulant therapy at therapeutic doses;
Single group
OMega 3
Dietary supplementThe 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. The product is provided as transparent hard capsules intended for oral administration. Dosage and administration: Participants 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. Treatment duration: The intervention will be administered for a total duration of 12 weeks.
Change from baseline in M1/M2 macrophage polarization markers in peripheral blood mononuclear cells (PBMCs)
Change from baseline to Week 12 in the expression of M1 (CD86, CD80, iNOS) and M2 (CD163, CD206, Arg1) macrophage polarization markers in PBMCs measured by RT-PCR and confirmed by Western blot.
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