Impact of an Optimized Omega-3 Formulation on Inflammation and Endothelial Dysfunction in Pulmonary Arterial Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 22
- 主要终点
- Change from baseline in M1/M2 macrophage polarization markers in peripheral blood mononuclear cells (PBMCs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
PAH Patients Receiving Omega-3
干预措施: OMega 3 (Dietary Supplement)
结局指标
主要结局
Change from baseline in M1/M2 macrophage polarization markers in peripheral blood mononuclear cells (PBMCs)
时间窗: 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.
次要结局
未报告次要终点