Impact of an Optimized Omega-3 Formulation on Inflammation and Endothelial Dysfunction in Pulmonary Arterial Hypertension

Impact of an Optimized Omega-3 Formulation on Inflammation and Endothelial Dysfunction in Pulmonary Arterial Hypertension

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.

Inclusion Criteria:

• 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;

• Subjects enrolled in a health insurance plan;

• Subjects who have signed an informed consent form;

• For women of childbearing age: negative pregnancy test at the screening/inclusion visit; effective contraception* throughout the study (recommended in PAH)

  • 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.

Exclusion criteria:

• 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;
• Cardiac decompensation within the month prior to enrollment;
• Other causes of pulmonary hypertension (groups 2, 3, 4, or 5);
• Persistent atrial fibrillation (AF);
• Left ventricular ejection fraction < 45% on echocardiography;
• Recent episode of pulmonary embolism, within the past 6 months;
• Myocardial infarction or placement of a coronary stent within the month prior to enrollment;
• eGFR < 30 mL/min/1.73 m²;
• Malignant disease (not considered in remission);
• Severe sepsis;
• Participation in another clinical trial within the previous 3 months;
• Subjects under legal guardianship, conservatorship, or curatorship