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Homoarginine Supplementation in Patients After Stroke (HiS)

Primary Purpose

Deficiency; Diet

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
125 mg L-homoarginine
placebo
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Deficiency; Diet focused on measuring homoarginine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ischemic stroke (CT or MRI), high-risk transient ischemic attack (ABCD2-score >= 4) or acute central retinal artery occlusion
  • serum homoarginine </= 2.1 umol/L
  • signed informed consent

Exclusion Criteria:

  • no acute stroke
  • serum homoarginine > 2.1 umol/L
  • heart failure (NYHA > 1)
  • chronic kidney disease (GFR <60 mL/min)
  • not competent
  • pregnancy, lactation
  • no or withdrawn signed informed consent

Sites / Locations

  • University Medical Center HamburgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

placebo

homoarginine

Arm Description

placebo capsules containing lactose - oral once weekly administration for six month

125 mg L-homoarginine supplement - oral once weekly administration for six month

Outcomes

Primary Outcome Measures

Homoarginine serum concentration
Normalization of homoarginine serum concentration to levels >2.1 umol/L.

Secondary Outcome Measures

Intima-media thickness
Intima-media thickness (IMT) measured at both common carotid arteries using an edge detection system. Plaques are defined as protrusion of ≥1.5 mm in common, internal and external carotid artery.
National Institute of Health Stroke Scale
National Institute of Health Stroke Scale (NIHSS) will be assessed by a neurologist. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 (normal) and 4 (maximum impairment). The maximum possible score is 42, with the minimum score being a 0.
Modified Ranking Scale
Modified Ranking Scale (mRS) is a scale for measuring the degree of disability of a stroke patients. The scale runs from 0 (perfect health) to 6 (death).

Full Information

First Posted
July 18, 2018
Last Updated
June 30, 2021
Sponsor
Universitätsklinikum Hamburg-Eppendorf
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1. Study Identification

Unique Protocol Identification Number
NCT03692234
Brief Title
Homoarginine Supplementation in Patients After Stroke
Acronym
HiS
Official Title
Homoarginine in Stroke (HiS) Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 22, 2018 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study represents a follow-up of the previous study "Single and Multiple Doses of an Oral Formulation of L-Homoarginine in Healthy Human Subjects" (NCT02675660). This study will evaluate the applicability of an oral formulation of L-homoarginine to normalize homoarginine blood levels in patients with acute ischemic stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deficiency; Diet
Keywords
homoarginine

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized double-blind placebo controlled
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo capsules containing lactose - oral once weekly administration for six month
Arm Title
homoarginine
Arm Type
Active Comparator
Arm Description
125 mg L-homoarginine supplement - oral once weekly administration for six month
Intervention Type
Dietary Supplement
Intervention Name(s)
125 mg L-homoarginine
Intervention Description
capsules for oral supplementation
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
capsules for oral supplementation
Primary Outcome Measure Information:
Title
Homoarginine serum concentration
Description
Normalization of homoarginine serum concentration to levels >2.1 umol/L.
Time Frame
six month
Secondary Outcome Measure Information:
Title
Intima-media thickness
Description
Intima-media thickness (IMT) measured at both common carotid arteries using an edge detection system. Plaques are defined as protrusion of ≥1.5 mm in common, internal and external carotid artery.
Time Frame
six month
Title
National Institute of Health Stroke Scale
Description
National Institute of Health Stroke Scale (NIHSS) will be assessed by a neurologist. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 (normal) and 4 (maximum impairment). The maximum possible score is 42, with the minimum score being a 0.
Time Frame
six month
Title
Modified Ranking Scale
Description
Modified Ranking Scale (mRS) is a scale for measuring the degree of disability of a stroke patients. The scale runs from 0 (perfect health) to 6 (death).
Time Frame
six month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ischemic stroke (CT or MRI), high-risk transient ischemic attack (ABCD2-score >= 4) or acute central retinal artery occlusion serum homoarginine </= 2.1 umol/L signed informed consent Exclusion Criteria: no acute stroke serum homoarginine > 2.1 umol/L heart failure (NYHA > 1) chronic kidney disease (GFR <60 mL/min) not competent pregnancy, lactation no or withdrawn signed informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chi-un Choe, MD
Phone
+49407410
Ext
22389
Email
cchoe@uke.de
First Name & Middle Initial & Last Name or Official Title & Degree
Edzard Schwedhelm, PhD
Phone
+49407410
Ext
54891
Email
schwedhelm@uke.de
Facility Information:
Facility Name
University Medical Center Hamburg
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chi-un Che, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27434056
Citation
Atzler D, Schonhoff M, Cordts K, Ortland I, Hoppe J, Hummel FC, Gerloff C, Jaehde U, Jagodzinski A, Boger RH, Choe CU, Schwedhelm E. Oral supplementation with L-homoarginine in young volunteers. Br J Clin Pharmacol. 2016 Dec;82(6):1477-1485. doi: 10.1111/bcp.13068. Epub 2016 Sep 20.
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Homoarginine Supplementation in Patients After Stroke

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