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

NCT07697235 | Not Yet Recruiting

• 1 other identifier: RC26_0129
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

PAH

Keywords

pulmonary arterial hypertension; inflammation; peripheral circulating cells; omega-3

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline to end of treatment (12 weeks)

Study Arms (1)

PAH Patients Receiving Omega-3

EXPERIMENTAL

Dietary Supplement: OMega 3

Interventions

OMega 3 DIETARY_SUPPLEMENT

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.

PAH Patients Receiving Omega-3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

MeSH Terms

Conditions

Pulmonary Arterial Hypertension; Inflammation

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Marianne RIOU, MD

  University Hospital, Strasbourg, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah HUSTACHE

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 13, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2030
• Last Updated: July 13, 2026

Record last verified: 2026-07