PAHOMEGA-PAHNCT07697235
Impact of an Optimized Omega-3 Formulation on Inflammation and Endothelial Dysfunction in Pulmonary Arterial Hypertension
A study testing OMega 3 in people with PAH, run by University Hospital, Strasbourg, France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- PAH
- What is being tested?
- OMega 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- OMega 3
- Keywords
- pulmonary arterial hypertension, inflammation, peripheral circulating cells, omega-3
- Medical subject headings
- Pulmonary Arterial Hypertension, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMega 3Dietary 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.
| Study group | Role | What they receive |
|---|---|---|
| PAH Patients Receiving Omega-3 | Experimental | Not described Receives: Dietary Supplement: OMega 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to end of treatment (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PAHStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marianne RIOU, MD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697235
- Sponsor's protocol ID
- RC26_0129
- Acronym
- OMEGA-PAH
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Optimized Omega-3 Formulation on Inflammation and Endothelial Dysfunction in Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT07697235
- Acronym / sponsor ID
- OMEGA-PAH / RC26_0129
- Conditions
- PAH
- Keywords
- pulmonary arterial hypertension, inflammation, peripheral circulating cells, omega-3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAH Patients Receiving Omega-3 | Experimental | Dietary Supplement: OMega 3 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OMega 3The 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. | Dietary supplement | PAH Patients Receiving Omega-3 |
Primary outcome
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)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
Related trials for PAH
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marianne RIOU, MD principal investigator
University Hospital, Strasbourg, France
Questions about this trial
What is this clinical trial studying?
A study testing OMega 3 in people with PAH, run by University Hospital, Strasbourg, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah HUSTACHE (+33 3 88 11 54 15 ext. 00 33, dpidrci@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.