Endocalyx in Treatment Resistent Hypertension

Official title

Glycocalyx Restoration in Treatment Resistant Hypertension: a Proof of Concept, Randomized, Double-blind, Placebo-controlled Study

Overview

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.

Interventions

• Dietary supplement Endocalyx Pro
  4 capsules once daily OR 2 capsules twice daily
• Other Placebo
  4 capsules once daily OR 2 capsules twice daily

Primary outcome measures

• Change from baseline in 24-hour systolic blood pressure [Time frame: 12 weeks]

Secondary outcome measures (12)

• 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]

Eligibility criteria

Inclusion criteria

• 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).

Exclusion criteria

• 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.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Netherlands · 1 center

• Amsterdam UMC — Amsterdam

Identifiers

NCT: NCT06940011 · NL85685.018.24

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗