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.
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.
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
Parallel
Endocalyx Pro
Dietary supplement4 capsules once daily OR 2 capsules twice daily
Placebo
Other intervention4 capsules once daily OR 2 capsules twice daily
Change from baseline in 24-hour systolic blood pressure
We will perform an uncorrected analysis and an analysis that is corrected for the reported and measured changes in antihypertensive medication use.
Change from baseline in 24-hour diastolic blood pressure
Change from baseline in seated systolic office blood pressure
Change from baseline in seated diastolic office blood pressure
Change from baseline in percentage of patients with a night-time blood pressure dip
The nighttime blood pressure dipping status will be measured with a 24-hour blood pressure measurements. Patients will be classified as a 'dippers' when the nighttime systolic blood pressure and/or diastolic blood pressure falls \>10% and \<20% compared to daytime readings. Exteme dippers are described as those with blood pressure fall of at least 20%. Patients with blood pressure fall between 0 and 10% are classified as non-dippers.
To assess whether sodium intake, measured using 24-hour urine collection, modulate the effect of Endocalyx on blood pressure.
We will study the (possible) modulatory effect sodium intake (mmol/L), measuring using 24 hours urine collection, on the effect of endocalyx on blood pressure.
To assess whether sex modulate the effect of Endocalyx on blood pressure.
The association between sex and the effect of endocalyx on blood pressure.
To assess whether kidney function modulate the effect of Endocalyx on blood pressure.
The association between kidney function and the effect of endocalyx on blood pressure.
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
Dutch Heart Foundation
Collaborator
Dutch Kidney Foundation
Collaborator
Microvascular Health Solutions LLC
Collaborator
