Endocalyx in Treatment Resistent Hypertension

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

About this trial

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

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Endocalyx Pro
  • Placebo

Treatment groups

64 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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

Lead sponsor

Dutch Heart Foundation

Collaborator

Dutch Kidney Foundation

Collaborator

Microvascular Health Solutions LLC

Collaborator