Endocalyx in Treatment Resistent Hypertension

Phase

Condition

Circulation Disorders

Stress

Vascular Diseases

Treatment

Endocalyx Pro

Placebo

Clinical Study ID

NCT06940011

NL85685.018.24

Ages > 18
All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

Treatment resistant hypertension defined as
an uncontrolled office BP (≥140/90 mmHg).
is on a regimen of ≥3 adequately dosed antihypertensive agents of differentclasses, including a diuretic, at maximum tolerated dose based on investigatorjudgment.
Stable diuretic and antihypertensive treatment for the previous 3 weeks.
Subject, or legal representative, has voluntarily signed and dated an InformedConsent Form, approved by the Independent Ethics Committee (IEC).

Exclusion

Exclusion Criteria:

Age <18 years.
Estimated glomerular filtration rate (eGFR) <20 ml/min/1.73m2 measured by the 2021Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine formula andthe 2012 cystatin C CKD-EPI formula.
A mean seated systolic blood pressure of at least 180 mmHg or a diastolic bloodpressure of at least 110 mmHg.
Known secondary hypertension
An acute coronary syndrome, stroke, transient ischemic attack or cardiovascularsurgery 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 liverdisease) with a life expectancy of less than 1 year.
A psychiatric, addictive or any disorder that compromises ability to give trulyinformed consent for participation in this study.
Known hypersensitivity to seaweed, corn, artichoke, grape, melon or to any of theexcipients of Endocalyx.
Known hypersensitivity or allergies for milk, eggs, fish, crustacean shellfish, treenuts, peanuts, wheat and soybeans.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactasedeficiency or glucose galactose malabsorption.

Study Design

Endocalyx Pro

January 21, 2025

January 01, 2028

Study 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.

Connect with a study center

Amsterdam UMC
Amsterdam, Noord-Holland 1105 AZ
Netherlands
Active - Recruiting

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