Clinical trial NCT06940011: Endocalyx in Treatment Resistent Hypertension
Official title: Glycocalyx Restoration in Treatment Resistant Hypertension: a Proof of Concept, Randomized, Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Treatment Resistant Hypertension
Keywords: Glycocalyx
Glycosaminoglycans
non-osmotic sodium storage
hypertension
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Dutch Heart Foundation
name: Dutch Kidney Foundation
name: Microvascular Health Solutions LLC
First posted: 2025-04-23
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, double-blind, placebo-controlled study
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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.

Primary outcomes:
measure: Change from baseline in 24-hour systolic blood pressure
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from baseline in 24-hour diastolic blood pressure
timeFrame: 12 weeks
measure: Change from baseline in seated systolic office blood pressure
timeFrame: 12 weeks
measure: Change from baseline in seated diastolic office blood pressure
timeFrame: 12 weeks
measure: Change from baseline in percentage of patients with a night-time blood pressure dip
timeFrame: 12 weeks
measure: Percentage of patients achieving a seated office blood pressure <140/90 mmHg after intervention
timeFrame: 12 weeks
measure: Percentage of patients that needed additional antihypertensive drugs and/or higher dosage of antihypertensive drugs during the study
timeFrame: 12 weeks
measure: Percentage of patients that required lowering of their antihypertensive drugs during the study
timeFrame: 12 weeks
measure: Change from baseline in total vessel density and perfused vessel density
timeFrame: 12 weeks
measure: Change from baseline in proportion of perfused vessels
timeFrame: 12 weeks
measure: Change from baseline in microvascular flow index
timeFrame: 12 weeks
measure: Change from baseline in microvascular health score
timeFrame: 12 weeks
measure: Change from baseline in heart rate
timeFrame: 12 weeks
measure: Change from baseline in total peripheral resistance
timeFrame: 12 weeks
measure: Change from baseline in cardiac output
timeFrame: 12 weeks
measure: Change from baseline in quality of life
timeFrame: 12 weeks
measure: The potential impact of Endocalyx on long-term cardiovascular protection and health care costs.
timeFrame: 12 weeks
measure: Change from baseline in skin sodium content
timeFrame: 12 weeks
measure: Change from baseline in muscle sodium content
timeFrame: 12 weeks
measure: Change from baseline in skin water content
timeFrame: 12 weeks
measure: Change from baseline in muscle water content
timeFrame: 12 weeks
measure: Change from baseline in transepidermal water loss
timeFrame: 12 weeks
measure: Change from baseline in skin hydration
timeFrame: 12 weeks
measure: Change from baseline in total body water
timeFrame: 12 weeks
measure: Incidence of adverse events in the Endocalyx group compared to the placebo group
timeFrame: 12 weeks
Other outcomes:
measure: To assess whether sodium intake, measured using 24-hour urine collection, modulate the effect of Endocalyx on blood pressure.
timeFrame: 12 weeks
measure: To assess whether sex modulate the effect of Endocalyx on blood pressure.
timeFrame: 12 weeks
measure: To assess whether kidney function modulate the effect of Endocalyx on blood pressure.
timeFrame: 12 weeks
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
state: Noord-Holland
Study officials:
References: