Endocalyx in Treatment Resistent Hypertension

Официальное название

Glycocalyx Restoration in Treatment Resistant Hypertension: a Proof of Concept, Randomized, Double-blind, Placebo-controlled Study

Обзор

The goal of this randomized, double-blind, placebo-controlled study is to assess whether the food supplement Endocalyx lowers blood pressure in patients with treatment resistant hypertension.

Подробное описание

During this intervention study, subjects will receive either a placebo or Endocalyx for 12 weeks. The main objective of this study is to assess whether the food supplement Endocalyx lowers blood pressure in patients with treatment resistant hypertension.

Secondary objectives are:

* Change from baseline in office blood pressure and 24-hour blood pressure profiles in subjects with treatment resistant hypertension. * To assess whether sodium intake, sex or kidney function modulates the effect of Endocalyx on blood pressure. * Change from baseline in total vessel density, perfused vessel density, proportion of perfused vessels and microvascular health score * To assess the effect of Endocalyx on total peripheral resistance. * The effect of Endocalyx on quality of life. * To estimate the potential impact of Endocalyx on long-term cardiovascular protection and health care costs.

Вмешательства

• Пищевая добавка Endocalyx Pro
  4 capsules once daily OR 2 capsules twice daily
• Другое Placebo
  4 capsules once daily OR 2 capsules twice daily

Первичные конечные точки

• Change from baseline in 24-hour systolic blood pressure [Срок оценки: 12 weeks]

Вторичные конечные точки (12)

• Change from baseline in 24-hour diastolic blood pressure [Срок оценки: 12 weeks]
• Change from baseline in seated systolic office blood pressure [Срок оценки: 12 weeks]
• Change from baseline in seated diastolic office blood pressure [Срок оценки: 12 weeks]
• Change from baseline in percentage of patients with a night-time blood pressure dip [Срок оценки: 12 weeks]
• Percentage of patients achieving a seated office blood pressure <140/90 mmHg after intervention [Срок оценки: 12 weeks]
• Percentage of patients that needed additional antihypertensive drugs and/or higher dosage of antihypertensive drugs during the study [Срок оценки: 12 weeks]
• Percentage of patients that required lowering of their antihypertensive drugs during the study [Срок оценки: 12 weeks]
• Change from baseline in total vessel density and perfused vessel density [Срок оценки: 12 weeks]
• Change from baseline in proportion of perfused vessels [Срок оценки: 12 weeks]
• Change from baseline in microvascular flow index [Срок оценки: 12 weeks]
• Change from baseline in microvascular health score [Срок оценки: 12 weeks]
• Change from baseline in heart rate [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• Treatment resistant hypertension defined as

• an uncontrolled office BP (≥140/90 mmHg).
• is on a regimen of ≥3 adequately dosed antihypertensive agents of different classes, including a diuretic, at maximum tolerated dose based on investigator judgment.
• Stable diuretic and antihypertensive treatment for the previous 3 weeks.
• Subject, or legal representative, has voluntarily signed and dated an Informed Consent Form, approved by the Independent Ethics Committee (IEC).

Критерии исключения

• Age <18 years.
• Estimated glomerular filtration rate (eGFR) <20 ml/min/1.73m2 measured by the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine formula and the 2012 cystatin C CKD-EPI formula.
• A mean seated systolic blood pressure of at least 180 mmHg or a diastolic blood pressure of at least 110 mmHg.
• Known secondary hypertension
• An acute coronary syndrome, stroke, transient ischemic attack or cardiovascular surgery in the last 3 months.
• Hospitalization for heart failure in the past 3 weeks.
• Dialysis treatment or expected initiation of dialysis within 3 months of screening.
• Women of child bearing potential who are not taking adequate contraception (i.e. <1% failure rate).
• Planned surgery in the next 12 weeks
• Major surgery in the previous 4 weeks.
• Use of prednisolone >5 mg/day
• Use of any other investigational drug.
• Presence of significant comorbidities (e.g., advanced malignancy, advanced liver disease) with a life expectancy of less than 1 year.
• A psychiatric, addictive or any disorder that compromises ability to give truly informed consent for participation in this study.
• Known hypersensitivity to seaweed, corn, artichoke, grape, melon or to any of the excipients of Endocalyx.
• Known hypersensitivity or allergies for milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans.
• Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• Amsterdam UMC — Amsterdam

Идентификаторы

NCT: NCT06940011 · NL85685.018.24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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