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

N/ANot Yet RecruitingNCT07697235

University Hospital, Strasbourg, France22 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

PAH

Interventions

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 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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: From baseline to end of treatment (12 weeks)