Endocalyx in Treatment Resistent Hypertension (GLYCO-TRH)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status and phase: Enrolling; Phase 2

Conditions: Treatment Resistant Hypertension

Treatments: Dietary Supplement: Endocalyx Pro; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06940011

NL85685.018.24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 2 patient groups, including a placebo group

Endocalyx Pro

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Endocalyx Pro

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo