Using Endocalyx to treat chronic heart failure

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

This study is testing if a food supplement called Endocalyx Pro can help people with chronic heart failure reduce excess sodium and water in their bodies and improve their quality of life.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years to 110 Years
• Sex: All
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Academic / other)
• Locations: 1 site (Amsterdam, North Holland)
• Trial ID: NCT05966415 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled study aims to evaluate the effectiveness of the food supplement Endocalyx Pro in reducing sodium and water excess in patients with chronic heart failure. Participants will be assigned to receive either Endocalyx or a placebo daily for 8 weeks, followed by a 12-week monitoring period. The study will assess various outcomes, including fluid overload symptoms, quality of life, and safety, while also exploring the mechanisms through which Endocalyx may exert its effects. Key measurements will include changes in tissue sodium content, body weight, blood pressure, and microcirculation characteristics.

Who should consider this trial

Good fit: Ideal candidates include individuals with documented or suspected heart failure with reduced ejection fraction and signs of congestion.

Not a fit: Patients without heart failure or those not experiencing fluid overload symptoms may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new dietary supplement option for managing fluid overload in chronic heart failure patients.

How similar studies have performed: While the specific use of Endocalyx is novel, similar approaches targeting sodium and water retention in heart failure have shown promise in other studies.

Eligibility criteria

Inclusion Criteria:

1. Documented or suspected heart failure with reduced ejection fraction (HFrEF and HFmrEF according to ESC guidelines).
2. Signs of congestion, defined as:

   a. Elevated NT-proBNP levels: i. \>450 pg/ml in subjects aged \<55 years. ii. \>900 pg/ml in subjects aged 55-75 years. iii. \>1800 pg/ml in subjects aged \>75 years. AND b. Use of diuretics, OR c. Presence of peripheral edema, OR d. Complaints of orthopnea or paroxysmal nocturnal dyspnea, OR e. A chest X-rays with sings of volume overload, OR f. Hypertension, as defined by an office blood pressure \>140/90 mmHg.
3. Stable diuretic and antihypertensive treatment for the previous 3 weeks.
4. Subject, or legal representative, has voluntarily signed and dated an Informed Consent Form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject has had the opportunity to ask questions. The informed consent must be signed before any study-specific procedures are performed.

Rationale for the inclusion criteria:

(1-3) To select the adequate subject population with appropriate disease severity for the evaluation. NT-proBNP levels are known to increase with age.(21, 22) The cutoffs of NT-proBNP levels were selected according the 2021 European Society of Cardiology Guidelines for the diagnosis and treatment of acute and chronic heart failure. (23) (4) In accordance with GCP.

Should inclusion prove difficult, we will lower required NT-proBNP levels by 25% to respectively 338, 675 and 1350 pg/ml. We will notify the METC of this decision.

Exclusion Criteria:

1. Age \<18 years.
2. Estimated glomerular filtration rate (eGFR) \<15 ml/min/1.73m2 measured by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
3. Systolic (\<105 mmHg) or diastolic hypotension (\<60 mmHg) as measured by office blood pressure measurements.
4. Severe symptoms of (orthostatic) hypotension.
5. An acute coronary syndrome, stroke, transient ischemic attack or cardiovascular surgery in the last 3 months.
6. Hospitalization for heart failure in the past 3 weeks.
7. Dialysis treatment or expected initiation of dialysis within 3 months of screening.
8. Women of child bearing potential.
9. Planned surgery in the next 8 weeks.
10. Major surgery in the previous 4 weeks.
11. Use of any other investigational drug.
12. Presence of significant comorbidities (e.g., advanced malignancy, advanced liver disease) with a life expectancy of less than 1 year.
13. A psychiatric, addictive or any disorder that compromises ability to give truly informed consent for participation in this study.
14. Known hypersensitivity to seaweed, corn, artichoke, grape, melon or to any of the excipients of Endocalyx.
15. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption.

Where this trial is running

Amsterdam, North Holland

• Amsterdam UMC — Amsterdam, North Holland, Netherlands (Recruiting)

Study contacts

• Principal investigator: Rik Olde Engberink — Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Study coordinator: Rik Olde Engberink, MD PhD

Conditions Chronic Heart Failure; Glycocalyx; Glycosaminoglycans; Non-osmotic sodium storage; Chronic heart failure