A supplement that could help heart failure patients shed excess fluid?
NCT ID NCT05966415
First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time
Summary
This trial tests whether a dietary supplement called Endocalyx Pro can reduce excess sodium and water in people with chronic heart failure. Participants will take either the supplement or a placebo daily for 8 weeks, with follow-up for 12 weeks. The study measures changes in a blood marker of fluid overload, blood pressure, and patient-reported symptoms like swelling and quality of life. It also aims to confirm the supplement's safety in this population.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Endocalyx Pro, a dietary supplement
- What this could lead to
- If effective, this supplement could offer a new way to manage fluid overload in heart failure, potentially reducing symptoms and improving quality of life.
- What could go wrong
- This is an early-stage proof-of-concept trial with a small number of participants, so results may not be conclusive or generalizable. The supplement's benefits and safety are not yet established.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 64 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2023
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 110 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. Severe symptoms of (orthostatic) hypotension. 4. An acute coronary syndrome, stroke, transient ischemic attack or cardiovascular surgery in the last 3 months. 5. Hospitalization for heart failure in the past 3 weeks. 6. Dialysis treatment or expected initiation of dialysis within 3 months of screening. 7. Women of child bearing potential. 8. Planned surgery in the next 8 weeks. 9. Major surgery in the previous 4 weeks. 10. Use of any other investigational drug. 11. Presence of significant comorbidities (e.g., advanced malignancy, advanced liver disease) with a life expectancy of less than 1 year. 12. A psychiatric, addictive or any disorder that compromises ability to give truly informed consent for participation in this study. 13. Known hypersensitivity to seaweed, corn, artichoke, grape, melon or to any of the excipients of Endocalyx. 14. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose galactose malabsorption.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Amsterdam UMC
Amsterdam, North Holland, 1105 AZ, Netherlands
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