Endocalyx for Heart Failure - Trial NCT05966415
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.
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Study Focus
Sponsor & Location
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Timeline & Enrollment
Phase 2
Apr 21, 2023
Oct 01, 2026
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
Data Source
ClinicalTrials.gov
NCT05966415
Non-Device Trial