NCT06940011

Endocalyx in Treatment Resistent Hypertension

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Endocalyx Pro	4 capsules once daily OR 2 capsules twice daily
OTHER	Placebo	4 capsules once daily OR 2 capsules twice daily

Timeline

• Start date: 2025-01-21
• Primary completion: 2027-12-01
• Completion: 2028-01-01
• First posted: 2025-04-23
• Last updated: 2025-04-23

Locations

1 site across 1 country: Netherlands