Homoarginine Supplementation in Patients After Stroke

Deficiency; Diet Clinical Trial

— HiS  

Official title:

Homoarginine in Stroke (HiS) Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03692234
• Other study ID #: Homoarginine in Stroke
• Status: Recruiting
• Phase: N/A
• Start date: August 22, 2018
• Est. completion date: August 2023

Study information

• Verified date: June 2021
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Chi-un Choe, MD
• Phone: +49407410
• Email: cchoe[@]uke.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: August 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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• no or withdrawn signed informed consent

Related Conditions & MeSH terms

• Deficiency; Diet
• Malnutrition

Intervention

Dietary Supplement:
• 125 mg L-homoarginine
capsules for oral supplementation

Other:
• placebo
capsules for oral supplementation

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Atzler D, Schönhoff M, Cordts K, Ortland I, Hoppe J, Hummel FC, Gerloff C, Jaehde U, Jagodzinski A, Böger 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Homoarginine serum concentration	Normalization of homoarginine serum concentration to levels >2.1 umol/L.	six month
Secondary	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.	six month
Secondary	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.	six month
Secondary	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).	six month