Using Endocalyx to lower blood pressure in patients with treatment resistant hypertension

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

This study is testing if a food supplement called Endocalyx can help lower blood pressure in people who have high blood pressure that hasn't responded to other treatments.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (other)
• Locations: 1 site (Amsterdam, North Holland)
• Trial ID: NCT06940011 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled intervention assesses the efficacy of the food supplement Endocalyx in lowering blood pressure among patients with treatment resistant hypertension. Participants will receive either Endocalyx or a placebo for a duration of 12 weeks. The study aims to evaluate changes in blood pressure, microvascular health, and quality of life, while also exploring the influence of sodium intake, sex, and kidney function on treatment outcomes. Secondary objectives include assessing long-term cardiovascular protection and healthcare cost implications.

Who should consider this trial

Good fit: Ideal candidates are adults with treatment resistant hypertension who are on a regimen of at least three antihypertensive medications.

Not a fit: Patients under 18 years old or those with severely elevated blood pressure or secondary hypertension may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new dietary intervention for patients struggling to control their blood pressure despite existing treatments.

How similar studies have performed: While the approach of using dietary supplements for hypertension is explored, this specific intervention with Endocalyx is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Treatment resistant hypertension defined as

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

Exclusion Criteria:

1. Age \<18 years.
2. 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.
3. A mean seated systolic blood pressure of at least 180 mmHg or a diastolic blood pressure of at least 110 mmHg.
4. Known secondary hypertension
5. An acute coronary syndrome, stroke, transient ischemic attack or cardiovascular surgery in the last 3 months.
6. Hospitalization for heart failure in the past 3 weeks.
7. Dialysis treatment or expected initiation of dialysis within 3 months of screening.
8. Women of child bearing potential who are not taking adequate contraception (i.e. \<1% failure rate).
9. Planned surgery in the next 12 weeks
10. Major surgery in the previous 4 weeks.
11. Use of prednisolone \>5 mg/day
12. Use of any other investigational drug.
13. Presence of significant comorbidities (e.g., advanced malignancy, advanced liver disease) with a life expectancy of less than 1 year.
14. A psychiatric, addictive or any disorder that compromises ability to give truly informed consent for participation in this study.
15. Known hypersensitivity to seaweed, corn, artichoke, grape, melon or to any of the excipients of Endocalyx.
16. Known hypersensitivity or allergies for milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans.
17. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption.

Where this trial is running

Amsterdam, North Holland

• Amsterdam UMC — Amsterdam, North Holland, Netherlands (RECRUITING)

Study contacts

• Study coordinator: Rik Olde Engberink, MD PhD

Conditions: Treatment Resistant Hypertension, Glycocalyx, Glycosaminoglycans, non-osmotic sodium storage, hypertension