RecruitingPhase 2NCT06940011
Endocalyx in Treatment Resistent Hypertension
Glycocalyx Restoration in Treatment Resistant Hypertension: a Proof of Concept, Randomized, Double-blind, Placebo-controlled Study
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Enrollment
64 participants
Start Date
Jan 21, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- 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 Criteria17
- 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.
Interventions
DIETARY_SUPPLEMENTEndocalyx Pro
4 capsules once daily OR 2 capsules twice daily
OTHERPlacebo
4 capsules once daily OR 2 capsules twice daily
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06940011