Impact of an Optimized Omega-3 Formulation on Inflammation and Endothelial Dysfunction in Pulmonary Arterial Hypertension (OMEGA-PAH)
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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Sarah HUSTACHE
- 電話番号：00 33 +33 3 88 11 54 15
- メール：dpidrci@chru-strasbourg.fr
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：PAH Patients Receiving Omega-3
|
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline in M1/M2 macrophage polarization markers in peripheral blood mononuclear cells (PBMCs)
時間枠：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.
|
From baseline to end of treatment (12 weeks)
|
協力者と研究者
捜査官
- 主任研究者：Marianne RIOU, MD、University Hospital, Strasbourg, France
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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