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
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