Chronic Heart FailurePhase 2GLYCO-HFNCT05966415
Endocalyx for Heart Failure
A Phase 2 study testing Endocalyx Pro in people with Chronic Heart Failure, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Endocalyx Pro
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Apr 2023to 30 Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented or suspected heart failure with reduced ejection fraction (HFrEF and HFmrEF according to ESC guidelines).
- Signs of congestion, defined as:
- 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.
- 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.
Who cannot join
- Age <18 years.
- Estimated glomerular filtration rate (eGFR) <15 ml/min/1.73m2 measured by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Glycocalyx Restoration in Chronic Heart Failure: a Proof of Concept, Randomized, Double-blind, Placebo-controlled Study
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:
Read more
- To assess whether the food supplement Endocalyx reduces sodium and water excess in patients with chronic heart failure.
- To determine the contribution of different potential working mechanisms of Endocalyx in heart failure patients.
- To evaluate whether the food supplement Endocalyx will improve patient-reported outcomes such as fluid overload symptoms and quality of life.
- 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.
Read the detailed description
Primary Objective:
- To assess whether the food supplement Endocalyx Pro™ (further termed Endocalyx) reduces sodium and water excess in patients with chronic heart failure.
Secondary Objectives:
- To evaluate whether Endocalyx will improve physical limitations and patient-reported outcomes such as fluid overload symptoms and quality of life.
- To determine the working mechanisms of Endocalyx in heart failure patients.
- To determine whether Endocalyx will alter tissue sodium content.
- To analyze whether Endocalyx reduces total body water and body weight.
- To assess whether Endocalyx affects office blood pressure, 24-hour blood pressure, peripheral resistance and cardiac output.
- To assess whether Endocalyx improves microcirculation characteristics.
- To evaluate whether Endocalyx reduces systemic inflammation and monocyte activation.
- To confirm safety of Endocalyx in the heart failure population a. To compare the incidence of (serious) adverse events between Endocalyx and placebo.
- Conditions
- Chronic Heart Failure
- Being tested
- Endocalyx Pro, placebo
- Keywords
- Glycocalyx, Glycosaminoglycans, Non-osmotic sodium storage, Chronic heart failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endocalyx ProDietary supplement
Also called Endocalyx
4 capsules once daily OR 2 capsules twice daily.
placeboOther
4 capsules once daily OR 2 capsules twice daily
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NT-proBNP in patients with chronic heart failure with (mildly) reduced ejection fraction.
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. The primary analysis will be performed using a mixed model for repeated measures (MMRM) on log-transformed NT-proBNP values. We will first fit models to analyze the overall treatment effect, and thereafter fit different models to assess the treatment effect over time (visit-specific).
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
Measured: 8 weeks
Secondary outcomes (32)
Change in 24 hour blood pressure, daytime blood pressure, nighttime blood pressure in Endocalyx treated patients when compared with subject receiving Placebo
24-hour ambulatory blood pressure (systolic blood pressure, diastolic blood pressure and mean arterial blood pressure) will be measured at screening, week 4 and week 8
Measured: 8 weeks
Change in total body water in Endocalyx treated patients when compared with subject receiving Placebo
Total body water and body weight will be measured with a body composition monitor at week 0 (randomization visit), 4 and 8
Measured: 8 weeks
Change in body weight (in kilograms) in Endocalyx treated patients when compared with subject receiving Placebo
Body weight will be measured at week 0 (randomization visit), 4 and 8
Measured: 8 weeks
Change in hemodynamic parameters in Endocalyx treated patients when compared with subject receiving Placebo
Nexfin will be used to measure hemodynamic parameters (such as heart rate, cardiac output and total peripheral resistance) at week 0 (randomization visit), 4 and 8
Measured: 8 weeks
Concentration change of Adrenomedullin in Endocalyx treated patients when compared with subject receiving Placebo
Adrenomedullin concentrations willl be measured in plasma. Blood will be collected at visits 0,1,2 and 3 (week 0-8)
Measured: 0-8 weeks
Change/difference in ratio of classical, non-classical and intermediate monocyte subsets.
will be isolated from peripheral blood mononuclear cells (PBMCs) collected at week 0 and 8
Measured: 0-8 weeks
Difference in chemokine. scavenger receptors, and surface proteins associated with monocyte adhesion, migration and activation concentrations, in Endocalyx treated patients when compared with subject receiving Placebo
will be isolated from peripheral blood mononuclear cells (PBMCs) collected at week 0 and 8
Measured: 8 weeks
Lipopolysaccharide-mediated cytokine secretion of monocytes in vitro in Endocalyx treated patients when compared with subjects receiving Placebo
will be isolated from peripheral blood mononuclear cells (PBMCs) collected at week 0 and 8
Measured: 8 weeks
Difference in hospitalization rates due to heart failure in Endocalyx treated patients when compared with subjects receiving Placebo
(serious) adverse events will be asked regularly throughout the study (during each study visit, and telephone call)
Measured: 12 weeks
Distance covered during the 6 minute walking tests in Endocalyx treated patients when compared with subjects receiving Placebo
Difference and change in meters covered during the six minute walking tests will be assessed during visit 0 (week 0) and 3 (week 8)
Measured: 8 weeks
Change in self-reported Quality of life in Endocalyx treated patients when compared with subjects receiving Placebo
Quality of life assessment with the RAND-36 and the Dutch version of the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The MLHFQ is one of the most widely used instruments for evaluating health-related quality of life in heart failure patients internationally and has been recommended by a systematic and reliable expert-based evaluation of available heart failure-specific health-related quality of life questionnaires.
Questionnaires will be filled in at week 0,4an 8
Measured: 8 weeks
Difference in incidence of (serious) adverse events in Endocalyx treated patients when compared with subjects receiving Placebo
(serious) adverse events will be asked regularly throughout the study (during each study visit, and telephone call)
Measured: 12 weeks
Pharmacokinetics of Endocalyx
(precursors of) glycosaminoglycans will be measured in urine and blood at set timepoints in a subset of patients who give additional informed consent at week 0,4 and 8
Measured: 0-8 weeks
Skin sodium content in skin biopsies
In a subset of patients who give additional informed consent for skin biopsies, skin sodium content will be measured.
Changes and differences in Endocalyx treated patients will be compared with subjects receiving Placebo.
Skin biopsies will be taken at week 0 and 8.
Measured: 0-8 weeks
monocyte and macrophage expression and density in skin biopsies
In a subset of patients who give additional informed consent for skin biopsies the migration of monocytes, skin macrophage density and expression will be assessed.
Changes and differences in Endocalyx treated patients will be compared with subjects receiving Placebo.
Skin biopsies will be taken at week 0 and 8.
Measured: 0-8 weeks
Change/difference in blood pressure in Endocalyx treated patients when compared with subjects receiving Placebo
Office blood pressure (systolic and diastolic blood pressure) will be measured (standardized) during each study visit.
Measured: 12 weeks
Difference/Change in 24-hour urine sodium and potassium excretion in Endocalyx treated patients when compared with subjects receiving Placebo
Subjects will collect 24-hour urine for the visits 1 and 3 (week 0 and 8 respectively)
Measured: 8 weeks
Plasma aldosterone and renin change/difference in Endocalyx treated patients when compared with subjects receiving Placebo
Blood will be collected at visits 0,1,2 and 3 (week 0-8)
Measured: 8 weeks
Differential treatment effects of Endocalyx in male and female patients
Exploratory subgroup analyses are planned to evaluate differential treatment effects of Endocalyx in male and female patients. Previous studies have demonstrated that women have lower skin sodium content than men and show less of an increase in skin sodium content after a high sodium diet.(36, 37) Also, heart failure is different in men and women. Women are more likely to have a non-ischemic ideology and hypertension as a cause of heart failure, and respond differently to treatment.(38) Considering these important gender differences in both heart failure characteristics and the suggested working mechanism of Endocalyx, it is likely that Endocalyx will have different effects in men and women.
Measured: 12 weeks
Percent change in antihypertensive drug dosage or number prescribed
% change in antihypertensive drug dosage or number prescribed in Endocalyx treated patients when compared with subjects receiving Placebo. Medication will be reviewed during visits 0-3 and during the telephone calls
Measured: 8 weeks
Percent change in diuretics (dosage or number prescribed)
% change in diuretics (dosage or number prescribed) prescribed in Endocalyx treated patients when compared with subjects receiving Placebo. Medication will be reviewed during visits 0-3 and during the telephone calls
Measured: 8 weeks
Change from baseline in total vessel density and perfused vessel density
The total vessel density and perfused vessel density will be measured using Sidestream Dark Field imaging
Measured: 8 weeks
Change from baseline in VEGF-C
Vascular endothelial growth factor C (VEGF-C) levels (in pg/mL) will be determined with ELISA
Measured: 8 weeks
Change from baseline in proportion of perfused vessels
The proportion of perfussed vessels will be measured using Sidestream Dark Field imaging.
Measured: 8 weeks
Change from baseline in microvascular flow index
The microvascular flow index will be measured using Sidestream Dark Field imaging.
Measured: 8 weeks
Change from baseline in microvascular health score
The microvascular health score will be measured using Sidestream Dark Field imaging.
Measured: 8 weeks
Change from baseline in transepidermal water loss
Transepidermal water loss will be measured with the Tewameter® TM Hex probe
Measured: 8 weeks
Change from baseline in skin hydration
The skin hydration will be measured using the Corneometer® CM 825 probeTime
Measured: 8 weeks
Change from baseline in VEGF-A
Vascular endothelial growth factor A (VEGF-A) levels (in pg/mL) will be determined with ELISA
Measured: 8 weeks
Change from baseline in Angiopoietin 1
Angiopoietin 1 levels (in pg/mL) will be determined with ELISA
Measured: 8 weeks
Change from baseline in Angiopoietin 2
Angiopoietin 2 levels (in pg/mL) will be determined with ELISA
Measured: 8 weeks
Change from baseline in TIE2
TIE 2 levels (in pg/mL) will be determined with ELISA
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start21 Apr 2023
- Primary completion1 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double-blind, placebo-controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rik Olde Engberink, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Rik Olde Engberink, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966415
- Sponsor's protocol ID
- NL81588.018.22
- Acronym
- GLYCO-HF
- Status last verified
- Aug 2026
- First submitted
- 30 Mar 2023
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycocalyx Restoration in Chronic Heart Failure: a Proof of Concept, Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT05966415
- Acronym / sponsor ID
- GLYCO-HF / NL81588.018.22
- Conditions
- Chronic Heart Failure
- Keywords
- Glycocalyx, Glycosaminoglycans, Non-osmotic sodium storage, Chronic heart failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess whether the food supplement Endocalyx reduces sodium and water excess in patients with chronic heart failure.
- To determine the contribution of different potential working mechanisms of Endocalyx in heart failure patients.
- To evaluate whether the food supplement Endocalyx will improve patient-reported outcomes such as fluid overload symptoms and quality of life.
- 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.
Detailed description
Primary Objective:
- To assess whether the food supplement Endocalyx Pro™ (further termed Endocalyx) reduces sodium and water excess in patients with chronic heart failure.
Secondary Objectives:
- To evaluate whether Endocalyx will improve physical limitations and patient-reported outcomes such as fluid overload symptoms and quality of life.
- To determine the working mechanisms of Endocalyx in heart failure patients.
- To determine whether Endocalyx will alter tissue sodium content.
- To analyze whether Endocalyx reduces total body water and body weight.
- To assess whether Endocalyx affects office blood pressure, 24-hour blood pressure, peripheral resistance and cardiac output.
- To assess whether Endocalyx improves microcirculation characteristics.
- To evaluate whether Endocalyx reduces systemic inflammation and monocyte activation.
- To confirm safety of Endocalyx in the heart failure population a. To compare the incidence of (serious) adverse events between Endocalyx and placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- randomized, double-blind, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Endocalyx Pro | Experimental | Dietary Supplement: Endocalyx ProEndocalyx 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. |
| Placebo | Placebo comparator | Other: placeboPlacebo 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. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Documented or suspected heart failure with reduced ejection fraction (HFrEF and HFmrEF according to ESC guidelines).
- Signs of congestion, defined as:
- 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.
Key exclusion criteria (14 listed)
- Age <18 years.
- Estimated glomerular filtration rate (eGFR) <15 ml/min/1.73m2 measured by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endocalyx ProAlso: Endocalyx4 capsules once daily OR 2 capsules twice daily. | Dietary supplement | Endocalyx Pro |
| placebo4 capsules once daily OR 2 capsules twice daily | Other | Placebo |
Primary outcome
Change in NT-proBNP in patients with chronic heart failure with (mildly) reduced ejection fraction.
Time frame: 8 weeks
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. The primary analysis will be performed using a mixed model for repeated measures (MMRM) on log-transformed NT-proBNP values. We will first fit models to analyze the overall treatment effect, and thereafter fit different models to assess the treatment effect over time (visit-specific). 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
32 secondary outcomes
Change in 24 hour blood pressure, daytime blood pressure, nighttime blood pressure in Endocalyx treated patients when compared with subject receiving Placebo
Time frame: 8 weeks
Change in total body water in Endocalyx treated patients when compared with subject receiving Placebo
Time frame: 8 weeks
Change in body weight (in kilograms) in Endocalyx treated patients when compared with subject receiving Placebo
Time frame: 8 weeks
Change in hemodynamic parameters in Endocalyx treated patients when compared with subject receiving Placebo
Time frame: 8 weeks
Concentration change of Adrenomedullin in Endocalyx treated patients when compared with subject receiving Placebo
Time frame: 0-8 weeks
Change/difference in ratio of classical, non-classical and intermediate monocyte subsets.
Time frame: 0-8 weeks
Difference in chemokine. scavenger receptors, and surface proteins associated with monocyte adhesion, migration and activation concentrations, in Endocalyx treated patients when compared with subject receiving Placebo
Time frame: 8 weeks
Lipopolysaccharide-mediated cytokine secretion of monocytes in vitro in Endocalyx treated patients when compared with subjects receiving Placebo
Time frame: 8 weeks
Difference in hospitalization rates due to heart failure in Endocalyx treated patients when compared with subjects receiving Placebo
Time frame: 12 weeks
Distance covered during the 6 minute walking tests in Endocalyx treated patients when compared with subjects receiving Placebo
Time frame: 8 weeks
Change in self-reported Quality of life in Endocalyx treated patients when compared with subjects receiving Placebo
Time frame: 8 weeks
Difference in incidence of (serious) adverse events in Endocalyx treated patients when compared with subjects receiving Placebo
Time frame: 12 weeks
Pharmacokinetics of Endocalyx
Time frame: 0-8 weeks
Skin sodium content in skin biopsies
Time frame: 0-8 weeks
monocyte and macrophage expression and density in skin biopsies
Time frame: 0-8 weeks
Change/difference in blood pressure in Endocalyx treated patients when compared with subjects receiving Placebo
Time frame: 12 weeks
Difference/Change in 24-hour urine sodium and potassium excretion in Endocalyx treated patients when compared with subjects receiving Placebo
Time frame: 8 weeks
Plasma aldosterone and renin change/difference in Endocalyx treated patients when compared with subjects receiving Placebo
Time frame: 8 weeks
Differential treatment effects of Endocalyx in male and female patients
Time frame: 12 weeks
Percent change in antihypertensive drug dosage or number prescribed
Time frame: 8 weeks
Percent change in diuretics (dosage or number prescribed)
Time frame: 8 weeks
Change from baseline in total vessel density and perfused vessel density
Time frame: 8 weeks
Change from baseline in VEGF-C
Time frame: 8 weeks
Change from baseline in proportion of perfused vessels
Time frame: 8 weeks
Change from baseline in microvascular flow index
Time frame: 8 weeks
Change from baseline in microvascular health score
Time frame: 8 weeks
Change from baseline in transepidermal water loss
Time frame: 8 weeks
Change from baseline in skin hydration
Time frame: 8 weeks
Change from baseline in VEGF-A
Time frame: 8 weeks
Change from baseline in Angiopoietin 1
Time frame: 8 weeks
Change from baseline in Angiopoietin 2
Time frame: 8 weeks
Change from baseline in TIE2
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rik Olde Engberink principal investigator
Amsterdam UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Endocalyx Pro in people with Chronic Heart Failure, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in NT-proBNP in patients with chronic heart failure with (mildly) reduced ejection fraction. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.