Not Yet RecruitingNot Applicable

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

22 participantsStarted 2026-07

Plain-language summary

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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 withi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is testing an omega-3 formulation in PAH patients and hasn't started recruiting yet — given that it has no assigned phase, what does that mean for how much is already known about its safety and effectiveness for someone with my condition?
2The trial is measuring changes in immune cell markers called M1/M2 macrophage polarization in the blood — can you explain in plain terms what that means and whether those kinds of changes would be expected to translate into real improvements in how I feel or in my PAH progression?
3Since this study isn't recruiting yet, how long might it realistically be before I could even enroll, and would waiting potentially affect my current treatment plan or disease management?
4Would taking an omega-3 supplement as part of this trial interact with any of the PAH medications I'm already on, and is that something the research team would monitor closely?
5Before considering a study like this one, are there standard PAH treatments or currently active trials I should explore first that have more established evidence behind them?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline in M1/M2 macrophage polarization markers in peripheral blood mononuclear cells (PBMCs)

Timeframe: From baseline to end of treatment (12 weeks)

Trial details

NCT IDNCT07697235

SponsorUniversity Hospital, Strasbourg, France

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-03

Contact for this trial

Sarah HUSTACHE

+33 3 88 11 54 15 dpidrci@chru-strasbourg.fr

View on ClinicalTrials.gov More PAH trials