Endocalyx in Treatment Resistent Hypertension

NCT06940011 | Recruiting Phase 2 DMC

• 1 other identifier: NL85685.018.24
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Treatment Resistant Hypertension

Keywords

Glycocalyx; Glycosaminoglycans; non-osmotic sodium storage; hypertension

Outcome Measures

Primary Outcomes (1)

• Change from baseline in 24-hour systolic blood pressure

  We will perform an uncorrected analysis and an analysis that is corrected for the reported and measured changes in antihypertensive medication use.

  12 weeks

Secondary Outcomes (24)

• 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 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

Other Outcomes (3)

• To assess whether sodium intake, measured using 24-hour urine collection, modulate the effect of Endocalyx on blood pressure.

  12 weeks

• To assess whether sex modulate the effect of Endocalyx on blood pressure.

  12 weeks

• To assess whether kidney function modulate the effect of Endocalyx on blood pressure.

  12 weeks

Study Arms (2)

Endocalyx Pro

EXPERIMENTAL

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.

Dietary Supplement: Endocalyx Pro

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Endocalyx Pro DIETARY_SUPPLEMENT

4 capsules once daily OR 2 capsules twice daily

Endocalyx Pro

Placebo OTHER

4 capsules once daily OR 2 capsules twice daily

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Dutch Heart Foundation: collaborator
• Dutch Kidney Foundation: collaborator
• Microvascular Health Solutions LLC: collaborator

Study Sites (1)

Amsterdam UMC

Amsterdam, North Holland, 1105 AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Rik Olde Engberink, MD PhD

CONTACT

0031205661930; r.h.oldeengberink@amsterdamumc.nl

Sanédy Simon, MD

CONTACT

0031205667789; s.s.a.simon@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: randomized, double-blind, placebo-controlled study

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: April 23, 2025
• Study Start: January 21, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)