Endocalyx for Heart Failure

NCT05966415 | Recruiting Phase 2 DMC

• 1 other identifier: NL81588.018.22
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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. 1.To assess whether the food supplement Endocalyx reduces sodium and water excess in patients with chronic heart failure.
2. 2.To determine the contribution of different potential working mechanisms of Endocalyx in heart failure patients.
3. 3.To evaluate whether the food supplement Endocalyx will improve patient-reported outcomes such as fluid overload symptoms and quality of life.
4. 4.To confirm the previously demonstrated safety of Endocalyx in subjects with chronic heart failure.

Conditions

Chronic Heart Failure

Keywords

Glycocalyx; Glycosaminoglycans; Non-osmotic sodium storage; Chronic heart failure

Outcome Measures

Primary Outcomes (1)

• Percent change of NT-proBNP from baseline to week 8 in Endocalyx treated patients when compared with subject receiving Placebo

  Our primary outcome will be the degree of volume overload as measured by the change in NT-proBNP from baseline to the study end at 8 weeks. We will compare the proportional change in NT-proBNP from baseline (as defined by the geometric mean of the screening and week 0 visit) to week 8 in a logarithmic scale using an analysis of covariance (ANCOVA). Treatment will be included in the model as fixed factor, and gender (male versus female) and baseline NT-proBNP as covariates. Our primary analysis will be an intention-to-treat analysis. To check the robustness of our results, we will perform a per protocol analysis. Subjects that withdraw their consent and stop the study medication will be asked to consent for a NT-proBNP measurement at the scheduled end of the study. NT-proBNP will be measured at screening visit, week 0 (randomization), week 4 and 8

  8 weeks

Secondary Outcomes (21)

• Change in 24 hour blood pressure, daytime blood pressure, nighttime blood pressure in Endocalyx treated patients when compared with subject receiving Placebo

  8 weeks

• Change in total body water in Endocalyx treated patients when compared with subject receiving Placebo

  8 weeks

• Change in body weight (in kilograms) in Endocalyx treated patients when compared with subject receiving Placebo

  8 weeks

• Change in hemodynamic parameters in Endocalyx treated patients when compared with subject receiving Placebo

  8 weeks

• Concentration change of Adrenomedullin in Endocalyx treated patients when compared with subject receiving Placebo

  0-8 weeks

Study Arms (2)

Endocalyx Pro

EXPERIMENTAL

Endocalyx is a food supplement that is distributed by Microvascular Health Solutions LLC in Alpine, Utah. Patients will receive 4 capsules Endocalyx per day, for 8 consecutive weeks. The capsules are orally administered and can be taken with water, on an empty stomach or with food. If possible, the patient will take 2 capsules in the morning, and 2 capsules in the afternoon. If preferred by the patient, the 4 capsules could also be taken once daily in the morning.

Dietary Supplement: Endocalyx Pro

Placebo

PLACEBO COMPARATOR

Placebo pills will be provided by Microvascular Health Solutions and are matched with the Endocalyx capsules. The placebo capsules contain no active pharmaceutical ingredients and contain solely widely used excipients. Patients will receive 4 capsules of the placebo per day for 8 consecutive weeks. The capsules are orally administered and can be taken with water, on an empty stomach or with food. If possible, the patient will take 2 capsules in the morning, and 2 capsules in the afternoon. If preferred by the patient, the 4 capsules could also be taken once daily in the morning.

Other: placebo

Interventions

Endocalyx Pro DIETARY_SUPPLEMENT

4 capsules once daily OR 2 capsules twice daily.

Also known as: Endocalyx

Endocalyx Pro

placebo OTHER

4 capsules once daily OR 2 capsules twice daily

Placebo

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented or suspected heart failure with reduced ejection fraction (HFrEF and HFmrEF according to ESC guidelines).
• 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.
• Stable diuretic and antihypertensive treatment for the previous 3 weeks.
• 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.
• (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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Amsterdam UMC

Amsterdam, North Holland, 1105 AZ, Netherlands

RECRUITING

Study Officials

• Rik Olde Engberink

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rik Olde Engberink, MD PhD

CONTACT

0031205661930; r.h.oldeengberink@amsterdamumc.nl

Charlotte Zwager, MD

CONTACT

c.zwager@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Model Details: randomized, double-blind, placebo-controlled study

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: July 28, 2023
• Study Start: April 21, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 28, 2023

Record last verified: 2023-07

Locations

NL (1)