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Endocalyx for Heart Failure

NCT05966415 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2023-07-28

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Endocalyx Pro

4 capsules once daily OR 2 capsules twice daily.

OTHER

placebo

4 capsules once daily OR 2 capsules twice daily

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Rik Olde Engberink · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-21
Primary Completion
2026-09-30
Completion
2026-10-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05966415 on ClinicalTrials.gov