Ignite Creation Date:
2025-12-18 @ 8:27 AM
Ignite Modification Date:
2025-12-23 @ 9:31 PM
Study NCT ID:
NCT05966415
Status:
None
Last Update Posted:
2023-07-28 00:00:00
First Post:
2023-03-30 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endocalyx for Heart Failure
Sponsor:
None
Organization:
Study Overview
Official Title:
Glycocalyx Restoration in Chronic Heart Failure: a Proof of Concept, Randomized, Double-blind, Placebo-controlled Study
Status:
None
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GLYCO-HF
Brief Summary:
Primary Objective:
1\. To assess whether the food supplement Endocalyx Pro™ (further termed Endocalyx) reduces sodium and water excess in patients with chronic heart failure.
Secondary Objectives:
1. To evaluate whether Endocalyx will improve physical limitations and patient-reported outcomes such as fluid overload symptoms and quality of life.
2. To determine the working mechanisms of Endocalyx in heart failure patients.
1. To determine whether Endocalyx will alter tissue sodium content.
2. To analyze whether Endocalyx reduces total body water and body weight.
3. To assess whether Endocalyx affects office blood pressure, 24-hour blood pressure, peripheral resistance and cardiac output.
4. To assess whether Endocalyx improves microcirculation characteristics.
5. To evaluate whether Endocalyx reduces systemic inflammation and monocyte activation.
3. To confirm safety of Endocalyx in the heart failure population a. To compare the incidence of (serious) adverse events between Endocalyx and placebo.
1\. To assess whether the food supplement Endocalyx Pro™ (further termed Endocalyx) reduces sodium and water excess in patients with chronic heart failure.
Secondary Objectives:
1. To evaluate whether Endocalyx will improve physical limitations and patient-reported outcomes such as fluid overload symptoms and quality of life.
2. To determine the working mechanisms of Endocalyx in heart failure patients.
1. To determine whether Endocalyx will alter tissue sodium content.
2. To analyze whether Endocalyx reduces total body water and body weight.
3. To assess whether Endocalyx affects office blood pressure, 24-hour blood pressure, peripheral resistance and cardiac output.
4. To assess whether Endocalyx improves microcirculation characteristics.
5. To evaluate whether Endocalyx reduces systemic inflammation and monocyte activation.
3. To confirm safety of Endocalyx in the heart failure population a. To compare the incidence of (serious) adverse events between Endocalyx and placebo.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: