A Phase 2 interventional study of Endocalyx Pro and Placebo in Treatment Resistant Hypertension, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-23.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Phase 2, Interventional, and Treatment
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.
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:
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's planned enrollment of 64 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.
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Treatment resistant hypertension defined as
Exclusion Criteria:
Endocalyx is a food supplement that is distributed by Microvascular Health Solutions LLC in Chattanooga, Tennessee. Patients will receive 4 capsules Endocalyx per day, for 12 consecutive weeks. The capsules are orally administered and can be taken with water, on an empty stomach or with food. If possible, the patient will take 2 capsules in the morning, and 2 capsules in the afternoon. If preferred by the patient, the 4 capsules could also be taken once daily in the morning.
Dietary Supplement: Endocalyx Pro
Placebo pills will be provided by Microvascular Health Solutions and are matched with the Endocalyx capsules. The placebo capsules contain no active pharmaceutical ingredients and contain solely widely used excipients. Patients will receive 4 capsules of the placebo per day for 12 consecutive weeks. The capsules are orally administered and can be taken with water, on an empty stomach or with food. If possible, the patient will take 2 capsules in the morning, and 2 capsules in the afternoon. If preferred by the patient, the 4 capsules could also be taken once daily in the morning.
Other: Placebo
4 capsules once daily OR 2 capsules twice daily
4 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.
Time frame: 12 weeks
Change from baseline in 24-hour diastolic blood pressure
Time frame: 12 weeks
Change from baseline in seated systolic office blood pressure
Time frame: 12 weeks
Change from baseline in seated diastolic office blood pressure
Time frame: 12 weeks
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.
Time frame: 12 weeks
Percentage of patients achieving a seated office blood pressure <140/90 mmHg after intervention
Participants achieved a response if the systolic blood pressure is below 140 mmHg and the diastolic blood pressure is below 90 mmHg
Time frame: 12 weeks
Percentage of patients that needed additional antihypertensive drugs and/or higher dosage of antihypertensive drugs during the study
Time frame: 12 weeks
Percentage of patients that required lowering of their antihypertensive drugs during the study
Time frame: 12 weeks
Change from baseline in total vessel density and perfused vessel density
The total vessel density and perfused vessel density will be measured using Sidestream Dark Field imaging.
Time frame: 12 weeks
Change from baseline in proportion of perfused vessels
The proportion of perfussed vessels will be measured using Sidestream Dark Field imaging.
Time frame: 12 weeks
Change from baseline in microvascular flow index
The microvascular flow index will be measured using Sidestream Dark Field imaging.
Time frame: 12 weeks
Change from baseline in microvascular health score
The microvascular health score will be measured using Sidestream Dark Field imaging.
Time frame: 12 weeks
Change from baseline in heart rate
The heart rate will be measured using the Nexfin device
Time frame: 12 weeks
Change from baseline in total peripheral resistance
The total pheripheral resistance will be measured using the Nexfin device
Time frame: 12 weeks
Change from baseline in cardiac output
The cardiac output will be measured using the Nexfin device
Time frame: 12 weeks
Change from baseline in quality of life
Quality of life will be evaluated by the SF-36 questionnaire.
Time frame: 12 weeks
The potential impact of Endocalyx on long-term cardiovascular protection and health care costs.
The EQ-5D-5L questionnaire will be used to score a patient health status and will be transposed in quality adjusted life years (QALY's).
Time frame: 12 weeks
Change from baseline in skin sodium content
Skin sodium content will measured using a 7T sodium MRI
Time frame: 12 weeks
Change from baseline in muscle sodium content
Muscle sodium content will measured using a 7T sodium MRI
Time frame: 12 weeks
Change from baseline in skin water content
Skin water content will measured using a 7T H-MRI
Time frame: 12 weeks
Change from baseline in muscle water content
Muscle water content will measured using a 7T H-MRI
Time frame: 12 weeks
Change from baseline in transepidermal water loss
Transepidermal water loss will be measured with the Tewameter® TM Hex probe
Time frame: 12 weeks
Change from baseline in skin hydration
The skin hydration will be measured using the Corneometer® CM 825 probe
Time frame: 12 weeks
Change from baseline in total body water
The change in total body water (liter) will be measured using the bioelectrical impendance analysis
Time frame: 12 weeks
Incidence of adverse events in the Endocalyx group compared to the placebo group
Time frame: 12 weeks
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.
Time frame: 12 weeks
To assess whether sex modulate the effect of Endocalyx on blood pressure.
The association between sex and the effect of endocalyx on blood pressure.
Time frame: 12 weeks
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.
Time frame: 12 weeks
Plan to share: No — Individual participant data will not be shared with other researcher
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)