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| Name | Class |
|---|---|
| Dutch Heart Foundation | OTHER |
| Dutch Kidney Foundation | OTHER |
| Microvascular Health Solutions LLC | UNKNOWN |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endocalyx Pro | Dietary Supplement | 4 capsules once daily OR 2 capsules twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in 24-hour diastolic blood pressure | 12 weeks | |
| Change from baseline in seated systolic office blood pressure | 12 weeks | |
| Change from baseline in seated diastolic office blood pressure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| To assess whether sex modulate the effect of Endocalyx on blood pressure. |
Inclusion Criteria:
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).
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rik Olde Engberink, MD PhD | Contact | 0031205661930 | r.h.oldeengberink@amsterdamumc.nl | |
| Sanédy Simon, MD | Contact | 0031205667789 | s.s.a.simon@amsterdamumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC | Recruiting | Amsterdam | North Holland | 1105 AZ | Netherlands |
Individual participant data will not be shared with other researcher
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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randomized, double-blind, placebo-controlled study
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| Placebo |
| Other |
4 capsules once daily OR 2 capsules twice daily |
|
| 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. | 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 | 12 weeks |
| Percentage of patients that needed additional antihypertensive drugs and/or higher dosage of antihypertensive drugs during the study | 12 weeks |
| Percentage of patients that required lowering of their antihypertensive drugs during the study | 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. | 12 weeks |
| Change from baseline in proportion of perfused vessels | The proportion of perfussed vessels will be measured using Sidestream Dark Field imaging. | 12 weeks |
| Change from baseline in microvascular flow index | The microvascular flow index will be measured using Sidestream Dark Field imaging. | 12 weeks |
| Change from baseline in microvascular health score | The microvascular health score will be measured using Sidestream Dark Field imaging. | 12 weeks |
| Change from baseline in heart rate | The heart rate will be measured using the Nexfin device | 12 weeks |
| Change from baseline in total peripheral resistance | The total pheripheral resistance will be measured using the Nexfin device | 12 weeks |
| Change from baseline in cardiac output | The cardiac output will be measured using the Nexfin device | 12 weeks |
| Change from baseline in quality of life | Quality of life will be evaluated by the SF-36 questionnaire. | 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). | 12 weeks |
| Change from baseline in skin sodium content | Skin sodium content will measured using a 7T sodium MRI | 12 weeks |
| Change from baseline in muscle sodium content | Muscle sodium content will measured using a 7T sodium MRI | 12 weeks |
| Change from baseline in skin water content | Skin water content will measured using a 7T H-MRI | 12 weeks |
| Change from baseline in muscle water content | Muscle water content will measured using a 7T H-MRI | 12 weeks |
| Change from baseline in transepidermal water loss | Transepidermal water loss will be measured with the Tewameter® TM Hex probe | 12 weeks |
| Change from baseline in skin hydration | The skin hydration will be measured using the Corneometer® CM 825 probe | 12 weeks |
| Change from baseline in total body water | The change in total body water (liter) will be measured using the bioelectrical impendance analysis | 12 weeks |
| Incidence of adverse events in the Endocalyx group compared to the placebo group | 12 weeks |
The association between sex and the effect of endocalyx on blood pressure. |
| 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. | 12 weeks |