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The Effect of Oral SPM Supplementation on INflammation-induced Vascular Ageing in Obese Hypertensive Patients

RecruitingNAAges 18 Years - 85 YearsAllAssistance Publique - Hôpitaux de Paris
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In plain words

What the trial is, and whether it could suit you

Cardiovascular risk factors such as obesity, diabetes, high blood pressure, high cholesterol, or smoking are associated with an increased risk of events such as myocardial infarction, stroke, or peripheral artery disease. Lifestyle and dietary measures, as well as pharmacological treatments, can help correct these risk factors. However, several studies have shown that even with optimal treatment, individuals at high risk still face a residual cardiovascular risk. This phenomenon is primarily attributed to the development of vascular lesions, meaning damage within the blood vessels. These lesions are largely due to inflammation, an activated immune state that is more pronounced in overweight individuals and significantly contributes to vascular damage, potentially shortening the lifespan of those with cardiovascular disease. Although anti-inflammatory therapies have proven effective in

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age between 18 and 85 years,. * Hypertension controlled under pharmacological or non-pharmacological treatment, defined as office BP\< 140/90 mmHg at the Inclusion visit, * BMI \> 30 kg/m², * Stable antihypertensive treatment one month before inclusion (V1), * Signed informed consent, * Social security affiliation. Exclusion Criteria: * Secondary hypertension on the basis of medical history, * History of stroke in the previous 6 months on the basis of medical history, * Myocardial infarction in the previous 6 months on the basis of medical history, * Severe hepatic insufficiency on the basis of medical history, * Chronic kidney disease (DFG \< 30 ml/min 1.73 according to MDRD method), * Pregnancy or breast feeding, * Regular treatment with NO-donors or phosphodiesterase inhibitors, * Inability to comply with protocol requirements, * Patient under tutorship or / guardianship or/ safeguard of justice, and incapable to give informed consent, * Patient on AME (state medical aid), * Participation in another interventional study involving human participants , * Allergy to the ultrasound gel, * Hypersensitivity , allergy, or idiosyncratic reaction to omega-3 acids, fish or soya allergies. * Chronic inflammatory diseases, on the basis of medical history, * Chronic anti-inflammatory treatment administered within the past month preceding the Inclusion visit, * Any supplementation with omega-3 or omega-6 polyunsaturated fatty acids within the past month, * Life expectancy less than one year.
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What it tests

  • Oral SPM-enriched marine oil (LIPINOVA)
  • Placebo
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Where

1 site
Service de Pharmacologie - UF Pharmacologie Clinique
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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