NCT05966415

Endocalyx for Heart Failure

Glycocalyx Restoration in Chronic Heart Failure: 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 – 110 Years
• Healthy volunteers: Not accepted

Summary

The goal of this randomized, double-blind, placebo-controlled study is to assess whether the food supplement Endocalyx Pro reduces sodium and water excess in patients with chronic heart failure. The main questions it aims to answer are: 1. To assess whether the food supplement Endocalyx reduces sodium and water excess in patients with chronic heart failure. 2. To determine the contribution of different potential working mechanisms of Endocalyx in heart failure patients. 3. To evaluate whether the food supplement Endocalyx will improve patient-reported outcomes such as fluid overload symptoms and quality of life. 4. To confirm the previously demonstrated safety of Endocalyx in subjects with chronic heart failure. Participants will be randomized to Endocalyx Pro or Placebo daily for 8 weeks, and will be followed 12 weeks.

Detailed description

Primary Objective: 1\. To assess whether the food supplement Endocalyx Pro™ (further termed Endocalyx) reduces sodium and water excess in patients with chronic heart failure. Secondary Objectives: 1. To evaluate whether Endocalyx will improve physical limitations and patient-reported outcomes such as fluid overload symptoms and quality of life. 2. To determine the working mechanisms of Endocalyx in heart failure patients. 1. To determine whether Endocalyx will alter tissue sodium content. 2. To analyze whether Endocalyx reduces total body water and body weight. 3. To assess whether Endocalyx affects office blood pressure, 24-hour blood pressure, peripheral resistance and cardiac output. 4. To assess whether Endocalyx improves microcirculation characteristics. 5. To evaluate whether Endocalyx reduces systemic inflammation and monocyte activation. 3. To confirm safety of Endocalyx in the heart failure population a. To compare the incidence of (serious) adverse events between Endocalyx and placebo.

Conditions

• Chronic Heart Failure

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: 2023-04-21
• Primary completion: 2026-09-01
• Completion: 2026-10-01
• First posted: 2023-07-28
• Last updated: 2023-07-28

Locations

1 site across 1 country: Netherlands