NCT05966415: GLYCO-HF

Glycocalyx Restoration in Chronic Heart Failure: a Proof of Concept, Randomized, Double-blind, Placebo-controlled Study

Recruiting now Phase 2 Last updated 21 July 2023

What this trial tests

Phase 2 trial testing Endocalyx Pro in Chronic Heart Failure in 64 participants. Currently enrolling.

Timeline

21 April 2023

Primary endpoint
1 September 2026

1 October 2026

Quick facts

Lead sponsor	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	64
Start date	21 April 2023
Primary completion	1 September 2026
Estimated completion	1 October 2026
Sites	1 location across Netherlands

Drugs / interventions tested

• Endocalyx Pro
• placebo

Conditions studied

• Chronic Heart Failure — all drugs for Chronic Heart Failure →

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) — full company profile →

Who can join

Adults 18 to 110, any sex, with Chronic Heart Failure. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Percent change of NT-proBNP from baseline to week 8 in Endocalyx treated patients when compared with subject receiving Placebo
  Time frame: 8 weeks
  Our primary outcome will be the degree of volume overload as measured by the change in NT-proBNP from baseline to the study end at 8 weeks. We will compare the proportional change in NT-proBNP from baseline (as defined by the geometric mean of the screening and week 0 visit) to week 8 in a logarithmic scale using an analysis of covariance (ANCOVA). Treatment will be included in the model as fixed

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Association Between Endothelial Alterations, Cardiac Function, and Outcomes From Health to Heart Failure: Insight From the STANISLAS, MEDIA-DHF, and BIOSTAT-CHF Cohorts.
   Lagrange J, Jahangiri M, Baudry G, Mercier N, et al · · 2025 · cited 2× · PMID 40439171 · DOI 10.1161/jaha.124.040179