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NCT05966415

Endocalyx for Heart Failure

Glycocalyx Restoration in Chronic Heart Failure: a Proof of Concept, Randomized, Double-blind, Placebo-controlled Study
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)·Phase 2·ClinicalTrials.gov·dietary supplementRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Chronic Heart Failure
Drug/Device/Intervention
Endocalyx Pro
Study type
Interventional
Intervention type
dietary supplement
Sponsor & location
Primary sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Location
Amsterdam, Netherlands
Timeline & enrollment
Phase
Phase 2
Start date
Apr 21, 2023
End date
Oct 01, 2026
Enrollment
64 participants
Primary outcome

Percent change of NT-proBNP from baseline to week 8 in Endocalyx treated patients when compared with subject receiving Placebo

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.

ICD-10 classifications
Heart failureHeart failure, unspecifiedCongestive heart failureHypertensive heart disease with (congestive) heart failureHypertensive heart disease without (congestive) heart failure
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05966415
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05966415 through Pure Global AI's free database. This Phase 2 trial is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) and is currently Recruiting. The study focuses on Chronic Heart Failure. Target enrollment is 64 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.