Glycocalyx Restoration in Treatment Resistant Hypertension: a Proof of Concept, Randomized, Double-blind, Placebo-controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Change from baseline in 24-hour systolic blood pressure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Endocalyx Pro
Endocalyx is a food supplement that is distributed by Microvascular Health Solutions LLC in Chattanooga, Tennessee. Patients will receive 4 capsules Endocalyx per day, for 12 consecutive weeks. The capsules are orally administered and can be taken with water, on an empty stomach or with food. If possible, the patient will take 2 capsules in the morning, and 2 capsules in the afternoon. If preferred by the patient, the 4 capsules could also be taken once daily in the morning.
干预措施: Endocalyx Pro (Dietary Supplement)
Placebo
Placebo pills will be provided by Microvascular Health Solutions and are matched with the Endocalyx capsules. The placebo capsules contain no active pharmaceutical ingredients and contain solely widely used excipients. Patients will receive 4 capsules of the placebo per day for 12 consecutive weeks. The capsules are orally administered and can be taken with water, on an empty stomach or with food. If possible, the patient will take 2 capsules in the morning, and 2 capsules in the afternoon. If preferred by the patient, the 4 capsules could also be taken once daily in the morning.
干预措施: Placebo (Other)
结局指标
主要结局
Change from baseline in 24-hour systolic blood pressure
时间窗: 12 weeks
We will perform an uncorrected analysis and an analysis that is corrected for the reported and measured changes in antihypertensive medication use.
次要结局
- Change from baseline in muscle sodium content(12 weeks)
- Change from baseline in proportion of perfused vessels(12 weeks)
- Change from baseline in cardiac output(12 weeks)
- Change from baseline in skin water content(12 weeks)
- Change from baseline in muscle water content(12 weeks)
- Change from baseline in transepidermal water loss(12 weeks)
- Change from baseline in total body water(12 weeks)
- Incidence of adverse events in the Endocalyx group compared to the placebo group(12 weeks)
- Percentage of patients that required lowering of their antihypertensive drugs during the study(12 weeks)
- Change from baseline in 24-hour diastolic blood pressure(12 weeks)
- Change from baseline in seated systolic office blood pressure(12 weeks)
- Change from baseline in seated diastolic office blood pressure(12 weeks)
- Change from baseline in total vessel density and perfused vessel density(12 weeks)
- Change from baseline in microvascular flow index(12 weeks)
- Change from baseline in heart rate(12 weeks)
- Change from baseline in microvascular health score(12 weeks)
- Change from baseline in total peripheral resistance(12 weeks)
- Change from baseline in quality of life(12 weeks)
- The potential impact of Endocalyx on long-term cardiovascular protection and health care costs.(12 weeks)
- Change from baseline in skin sodium content(12 weeks)
- Change from baseline in skin hydration(12 weeks)
- Change from baseline in percentage of patients with a night-time blood pressure dip(12 weeks)
- Percentage of patients achieving a seated office blood pressure <140/90 mmHg after intervention(12 weeks)
- Percentage of patients that needed additional antihypertensive drugs and/or higher dosage of antihypertensive drugs during the study(12 weeks)
研究者
Rik Olde Engberink
Principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)