Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06940011

Endocalyx in Treatment Resistent Hypertension

Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2025-04-23

64

Participants Needed

1

Research Sites

153 weeks

Total Duration

On this page

Sponsors

A

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

Lead Sponsor

D

Dutch Heart Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Endocalyx in Treatment Resistent Hypertension

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Treatment resistant hypertension defined as uncontrolled office blood pressure (≥140/90 mmHg)
  • Currently taking at least 3 antihypertensive agents of different classes including a diuretic at maximum tolerated dose
  • Stable diuretic and antihypertensive treatment for at least 3 weeks
  • Signed informed consent form approved by an Independent Ethics Committee
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Estimated glomerular filtration rate (eGFR) less than 20 ml/min/1.73m2
  • Mean seated systolic blood pressure of at least 180 mmHg or diastolic blood pressure of at least 110 mmHg
  • Known secondary hypertension
  • 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 dialysis initiation within 3 months
  • Women of childbearing potential not using adequate contraception
  • Planned surgery within the next 12 weeks
  • Major surgery in the previous 4 weeks
  • Use of prednisolone over 5 mg/day
  • Use of any other investigational drug
  • Significant comorbidities with life expectancy less than 1 year
  • Psychiatric, addictive, or other disorders compromising informed consent
  • Known hypersensitivity to seaweed, corn, artichoke, grape, melon, or any excipients of Endocalyx
  • Known allergies to milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, or soybeans
  • Rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose galactose malabsorption

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Amsterdam UMC

Amsterdam, North Holland, Netherlands, 1105 AZ

Actively Recruiting

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Research Team

R

Rik Olde Engberink, MD PhD

CONTACT

S

Sanédy Simon, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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