Actively Recruiting

Phase 2
Age: 18Years - 110Years
All Genders
NCT05966415

Endocalyx for Heart Failure

Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2023-07-28

64

Participants Needed

1

Research Sites

179 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

Endocalyx for Heart Failure

Who Can Participate

Age: 18Years - 110Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Documented or suspected heart failure with reduced ejection fraction (HFrEF and HFmrEF according to ESC guidelines).
  • Signs of congestion, defined by elevated NT-proBNP levels based on age: >450 pg/ml if under 55 years, >900 pg/ml if 55-75 years, or >1800 pg/ml if over 75 years, plus use of diuretics or peripheral edema or orthopnea or paroxysmal nocturnal dyspnea or chest X-ray signs of volume overload or hypertension (office blood pressure >140/90 mmHg).
  • Stable diuretic and antihypertensive treatment for the previous 3 weeks.
  • Voluntarily signed informed consent approved by an Institutional Review Board or Independent Ethics Committee before any study procedures.
Not Eligible

You will not qualify if you...

  • Under 18 years of age.
  • Estimated glomerular filtration rate (eGFR) less than 15 ml/min/1.73m2.
  • Systolic blood pressure below 105 mmHg or diastolic blood pressure below 60 mmHg.
  • Severe symptoms of orthostatic hypotension.
  • Acute coronary syndrome, stroke, transient ischemic attack, or cardiovascular surgery within the last 3 months.
  • Hospitalization for heart failure in the past 3 weeks.
  • Dialysis treatment or expected to start dialysis within 3 months.
  • Women of childbearing potential.
  • Planned surgery in the next 8 weeks or major surgery in the previous 4 weeks.
  • Use of any other investigational drug.
  • Significant comorbidities with life expectancy under 1 year (e.g., advanced malignancy, advanced liver disease).
  • Psychiatric, addictive, or other disorders impairing informed consent.
  • Known hypersensitivity to seaweed, corn, artichoke, grape, melon, or any excipients of Endocalyx.
  • Rare hereditary problems like galactose intolerance, Lapp lactase deficiency, or glucose galactose malabsorption.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Amsterdam UMC

Amsterdam, North Holland, Netherlands, 1105 AZ

Actively Recruiting

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Research Team

R

Rik Olde Engberink, MD PhD

CONTACT

C

Charlotte Zwager, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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