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

Overview

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.

Interventions

• 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. The product is provided as transparent hard capsules intended for oral administration. Dosage and administration: Participants will receive a total of four capsules p

Primary outcome measures

• Change from baseline in M1/M2 macrophage polarization markers in peripheral blood mononuclear cells (PBMCs) [Time frame: From baseline to end of treatment (12 weeks)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07697235 · RC26_0129

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗