RecruitingPhase 2NCT05966415

Endocalyx for Heart Failure

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

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Enrollment

64 participants

Start Date

Apr 21, 2023

Study Type

INTERVENTIONAL

Conditions

Chronic Heart Failure

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.

Eligibility

Min Age: 18 YearsMax Age: 110 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a nutritional supplement called Endocalyx — designed to support the inner lining of blood vessels (called the glycocalyx) — in patients with heart failure to see if it improves heart function, reduces fluid buildup, and helps manage symptoms. **You may be eligible if...** - You have documented or suspected heart failure with reduced ejection fraction (HFrEF or HFmrEF) - You have signs of fluid congestion, such as elevated blood biomarkers (NT-proBNP), leg swelling, shortness of breath when lying down, or are using diuretics (water pills) **You may NOT be eligible if...** - Your heart failure is well-controlled without any signs of congestion - You have contraindications to the supplement's ingredients - You have advanced kidney or liver disease that would interfere with the study - You are enrolled in another clinical trial that conflicts with this one Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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