Homoarginine Supplementation in Patients After Stroke

Homoarginine in Stroke (HiS) Study

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03692234

Acronym

HiS

Enrollment

500

Registered

2018-10-02

Start date

2018-08-22

Completion date

2023-08-31

Last updated

2021-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deficiency; Diet

Keywords

homoarginine

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.

Interventions

DIETARY_SUPPLEMENT125 mg L-homoarginine

capsules for oral supplementation

OTHERplacebo

capsules for oral supplementation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Intervention model description

randomized double-blind placebo controlled

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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60 mL/min) * not competent * pregnancy, lactation * no or withdrawn signed informed consent

Design outcomes

Primary

Measure	Time frame	Description
Homoarginine serum concentration	six month	Normalization of homoarginine serum concentration to levels \>2.1 umol/L.

Secondary

Measure	Time frame	Description
Intima-media thickness	six month	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	six month	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	six month	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).

Countries

Germany

Contacts

Primary ContactChi-un Choe, MD

cchoe@uke.de+49407410

Backup ContactEdzard Schwedhelm, PhD

schwedhelm@uke.de+49407410

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026