NCT07697235Not yet recruiting
Impact of an Optimized Omega-3 Formulation on Inflammation and Endothelial Dysfunction in Pulmonary Arterial Hypertension
Source: ClinicalTrials.gov · Last updated 13 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 22 (estimated)
- First submitted
- 1 Jul 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 31 Mar 2029
- Lead sponsor
- University Hospital, Strasbourg, France
- NCT number
- NCT07697235
What you commit to
- Study type: Interventional
- Planned participants: 22
- From 1 Jul 2026 to the primary completion date, 31 Mar 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients treated with Omacor®;
- Anticoagulant therapy at therapeutic doses;
- Cardiac decompensation within the month prior to enrollment;
- Myocardial infarction or placement of a coronary stent within the month prior to enrollment;
- Participation in another clinical trial within the previous 3 months;
Other illness
- Hypersensitivity or allergy to fish, shellfish, peanuts, soy, corn oil, or coconut oil;
- Other causes of pulmonary hypertension (groups 2, 3, 4, or 5);
- Malignant disease (not considered in remission);
Lab values
- Left ventricular ejection fraction \< 45% on echocardiography;
- eGFR \< 30 mL/min/1.73 m²;
Other
- Daily consumption of fish oil or fish oil-based dietary supplements (omega-3);
- Persistent atrial fibrillation (AF);
- Recent episode of pulmonary embolism, within the past 6 months;
- Severe sepsis;
- Subjects under legal guardianship, conservatorship, or curatorship
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.