Treatment Resistant HypertensionPhase 2GLYCO-TRHNCT06940011
Endocalyx in Treatment Resistent Hypertension
A Phase 2 study testing Endocalyx Pro in people with Treatment Resistant Hypertension, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment Resistant Hypertension
- What is being tested?
- Endocalyx Pro
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Jan 2025to 1 Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Subject, or legal representative, has voluntarily signed and dated an Informed Consent Form, approved by the Independent Ethics Committee (IEC).
Who cannot join
- 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
- An acute coronary syndrome, stroke, transient ischemic attack or cardiovascular surgery in the last 3 months.
- Hospitalization for heart failure in the past 3 weeks.
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- Dialysis treatment or expected initiation of dialysis within 3 months of screening.
- Women of child bearing potential who are not taking adequate contraception (i.e. <1% failure rate).
- Planned surgery in the next 12 weeks
- Major surgery in the previous 4 weeks.
- Use of prednisolone >5 mg/day
- Use of any other investigational drug.
- Presence of significant comorbidities (e.g., advanced malignancy, advanced liver disease) with a life expectancy of less than 1 year.
- A psychiatric, addictive or any disorder that compromises ability to give truly informed consent for participation in this study.
- Known hypersensitivity to seaweed, corn, artichoke, grape, melon or to any of the excipients of Endocalyx.
- Known hypersensitivity or allergies for milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans.
- Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC
Amsterdam, North Holland, 1105 AZ
Rik Olde Engberink, MD PhD, +31(0)205661930, r.h.oldeengberink@amsterdamumc.nl
Sanédy Simon, MD, +31(0)20567789, s.s.a.simon@amsterdamumc.nl
About this study
Official title: Glycocalyx Restoration in Treatment Resistant Hypertension: a Proof of Concept, Randomized, Double-blind, Placebo-controlled Study
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.
Read the detailed description
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:
- Change from baseline in office blood pressure and 24-hour blood pressure profiles in subjects with treatment resistant hypertension.
- To assess whether sodium intake, sex or kidney function modulates the effect of Endocalyx on blood pressure.
- Change from baseline in total vessel density, perfused vessel density, proportion of perfused vessels and microvascular health score
- To assess the effect of Endocalyx on total peripheral resistance.
- The effect of Endocalyx on quality of life.
- To estimate the potential impact of Endocalyx on long-term cardiovascular protection and health care costs.
- Conditions
- Treatment Resistant Hypertension
- Being tested
- Endocalyx Pro, Placebo
- Keywords
- Glycocalyx, Glycosaminoglycans, non-osmotic sodium storage, hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endocalyx ProDietary supplement
4 capsules once daily OR 2 capsules twice daily
PlaceboOther
4 capsules once daily OR 2 capsules twice daily
| Study group | Role | What they receive |
|---|---|---|
| Endocalyx Pro | Experimental | 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. Receives: Dietary Supplement: Endocalyx Pro |
| Placebo | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (24)
Change from baseline in 24-hour diastolic blood pressure
Measured: 12 weeks
Change from baseline in seated systolic office blood pressure
Measured: 12 weeks
Change from baseline in seated diastolic office blood pressure
Measured: 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.
Measured: 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
Measured: 12 weeks
Percentage of patients that needed additional antihypertensive drugs and/or higher dosage of antihypertensive drugs during the study
Measured: 12 weeks
Percentage of patients that required lowering of their antihypertensive drugs during the study
Measured: 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.
Measured: 12 weeks
Change from baseline in proportion of perfused vessels
The proportion of perfussed vessels will be measured using Sidestream Dark Field imaging.
Measured: 12 weeks
Change from baseline in microvascular flow index
The microvascular flow index will be measured using Sidestream Dark Field imaging.
Measured: 12 weeks
Change from baseline in microvascular health score
The microvascular health score will be measured using Sidestream Dark Field imaging.
Measured: 12 weeks
Change from baseline in heart rate
The heart rate will be measured using the Nexfin device
Measured: 12 weeks
Change from baseline in total peripheral resistance
The total pheripheral resistance will be measured using the Nexfin device
Measured: 12 weeks
Change from baseline in cardiac output
The cardiac output will be measured using the Nexfin device
Measured: 12 weeks
Change from baseline in quality of life
Quality of life will be evaluated by the SF-36 questionnaire.
Measured: 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).
Measured: 12 weeks
Change from baseline in skin sodium content
Skin sodium content will measured using a 7T sodium MRI
Measured: 12 weeks
Change from baseline in muscle sodium content
Muscle sodium content will measured using a 7T sodium MRI
Measured: 12 weeks
Change from baseline in skin water content
Skin water content will measured using a 7T H-MRI
Measured: 12 weeks
Change from baseline in muscle water content
Muscle water content will measured using a 7T H-MRI
Measured: 12 weeks
Change from baseline in transepidermal water loss
Transepidermal water loss will be measured with the Tewameter® TM Hex probe
Measured: 12 weeks
Change from baseline in skin hydration
The skin hydration will be measured using the Corneometer® CM 825 probe
Measured: 12 weeks
Change from baseline in total body water
The change in total body water (liter) will be measured using the bioelectrical impendance analysis
Measured: 12 weeks
Incidence of adverse events in the Endocalyx group compared to the placebo group
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start21 Jan 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double-blind, placebo-controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Heart Foundation, Dutch Kidney Foundation, Microvascular Health Solutions LLC
- Responsible party
- Principal investigator, Rik Olde Engberink, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940011
- Sponsor's protocol ID
- NL85685.018.24
- Acronym
- GLYCO-TRH
- Status last verified
- Apr 2025
- First submitted
- 20 Jan 2025
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researcher
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycocalyx Restoration in Treatment Resistant Hypertension: a Proof of Concept, Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT06940011
- Acronym / sponsor ID
- GLYCO-TRH / NL85685.018.24
- Conditions
- Treatment Resistant Hypertension
- Keywords
- Glycocalyx, Glycosaminoglycans, non-osmotic sodium storage, hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Dutch Heart Foundation, Dutch Kidney Foundation, Microvascular Health Solutions LLC
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Change from baseline in office blood pressure and 24-hour blood pressure profiles in subjects with treatment resistant hypertension.
- To assess whether sodium intake, sex or kidney function modulates the effect of Endocalyx on blood pressure.
- Change from baseline in total vessel density, perfused vessel density, proportion of perfused vessels and microvascular health score
- To assess the effect of Endocalyx on total peripheral resistance.
- The effect of Endocalyx on quality of life.
- To estimate the potential impact of Endocalyx on long-term cardiovascular protection and health care costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, double-blind, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Endocalyx Pro | Experimental | Dietary Supplement: Endocalyx ProEndocalyx 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. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Treatment resistant hypertension defined as
- Stable diuretic and antihypertensive treatment for the previous 3 weeks.
- Subject, or legal representative, has voluntarily signed and dated an Informed Consent Form, approved by the Independent Ethics Committee (IEC).
Key exclusion criteria (17 listed)
- 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
- An acute coronary syndrome, stroke, transient ischemic attack or cardiovascular surgery in the last 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endocalyx Pro4 capsules once daily OR 2 capsules twice daily | Dietary supplement | Endocalyx Pro |
| Placebo4 capsules once daily OR 2 capsules twice daily | Other | Placebo |
Primary outcome
Change from baseline in 24-hour systolic blood pressure
Time frame: 12 weeks
We will perform an uncorrected analysis and an analysis that is corrected for the reported and measured changes in antihypertensive medication use.
24 secondary outcomes
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
Time frame: 12 weeks
Percentage of patients achieving a seated office blood pressure <140/90 mmHg after intervention
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
Time frame: 12 weeks
Change from baseline in proportion of perfused vessels
Time frame: 12 weeks
Change from baseline in microvascular flow index
Time frame: 12 weeks
Change from baseline in microvascular health score
Time frame: 12 weeks
Change from baseline in heart rate
Time frame: 12 weeks
Change from baseline in total peripheral resistance
Time frame: 12 weeks
Change from baseline in cardiac output
Time frame: 12 weeks
Change from baseline in quality of life
Time frame: 12 weeks
The potential impact of Endocalyx on long-term cardiovascular protection and health care costs.
Time frame: 12 weeks
Change from baseline in skin sodium content
Time frame: 12 weeks
Change from baseline in muscle sodium content
Time frame: 12 weeks
Change from baseline in skin water content
Time frame: 12 weeks
Change from baseline in muscle water content
Time frame: 12 weeks
Change from baseline in transepidermal water loss
Time frame: 12 weeks
Change from baseline in skin hydration
Time frame: 12 weeks
Change from baseline in total body water
Time frame: 12 weeks
Incidence of adverse events in the Endocalyx group compared to the placebo group
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researcher
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Endocalyx Pro in people with Treatment Resistant Hypertension, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rik Olde Engberink, MD PhD (0031205661930, r.h.oldeengberink@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in 24-hour systolic blood pressure (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.