Endocalyx in Treatment Resistent Hypertension

Phase 2RecruitingNCT06940011

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)64 enrolled

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Treatment Resistant Hypertension

Interventions

Endocalyx ProDIETARY_SUPPLEMENT

4 capsules once daily OR 2 capsules twice daily

PlaceboOTHER

4 capsules once daily OR 2 capsules twice daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Treatment resistant hypertension defined as 1. an uncontrolled office BP (≥140/90 mmHg). 2. is on a regimen of ≥3 adequately dosed antihypertensive agents of different classes, including a diuretic, at maximum tolerated dose based on investigator judgment. 2. Stable diuretic and antihypertensive treatment for the previous 3 weeks. 3. Subject, or legal representative, has voluntarily signed and dated an Informed Consent Form, approved by the Independent Ethics Committee (IEC). Exclusion Criteria: 1. Age \<18 years. 2. 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. 3. A mean seated systolic blood pressure of at least 180 mmHg or a diastolic blood pressure of at least 110 mmHg. 4. Known secondary hypertension 5. An acute coronary syndrome, stroke, transient ischemic attack or cardiovascular surgery in the last 3 months. 6. Hospitalization for heart failure in the past 3 weeks. 7. Dialysis treatment or expected initiation of dialysis within 3 months of screening. 8. Women of child bearing potential who are not taking adequate contraception (i.e. \<1% failure rate). 9. Planned surgery in the next 12 weeks 10. Major surgery in the previous 4 weeks. 11. Use of prednisolone \>5 mg/day 12. Use of any other investigational drug. 13. Presence of significant comorbidities (e.g., advanced malignancy, advanced liver disease) with a life expectancy of less than 1 year. 14. A psychiatric, addictive or any disorder that compromises ability to give truly informed consent for participation in this study. 15. Known hypersensitivity to seaweed, corn, artichoke, grape, melon or to any of the excipients of Endocalyx. 16. Known hypersensitivity or allergies for milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans. 17. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption.

Locations (1)

Amsterdam UMC

Amsterdam, North Holland, Netherlands

RECRUITING

Outcomes

Primary Outcomes

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

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

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

Central Contacts

Rik Olde Engberink, MD PhD

CONTACT

0031205661930 r.h.oldeengberink@amsterdamumc.nl

Sanédy Simon, MD

CONTACT

0031205667789 s.s.a.simon@amsterdamumc.nl

Data from ClinicalTrials.gov

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