Tests a food supplement for hard-to-control high blood pressure
Tests the Endocalyx supplement against a placebo in adults with treatment resistant hypertension.
Plain-language title generated from the registry record
Registry title: Endocalyx in Treatment Resistent Hypertension
Key facts
- Where
- Amsterdam, NetherlandsSee the site
- Phase
- Phase 2
Where in Netherlands
- Amsterdam UMCAmsterdam, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Trial code
- NCT06940011
- Record updated
- 23 April 2025
- Original description
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.Read full original descriptionShow less
Glycocalyx Restoration in Treatment Resistant Hypertension: a Proof of Concept, Randomized, Double-blind, Placebo-controlled Study
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.
Inclusion: 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).
Exclusion: Planned surgery in the next 12 weeks; Major surgery in the previous 4 weeks; Use of any other investigational drug; 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; Women of child bearing potential who are not taking adequate contraception (i.e. <1% failure rate); 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; 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; Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption; Age <18 years; A mean seated systolic blood pressure of at least 180 mmHg or a diastolic blood pressure of at least 110 mmHg; Dialysis treatment or expected initiation of dialysis within 3 months of screening; Use of prednisolone >5 mg/day.