HiS: Homoarginine Supplementation in Patients After Stroke

Sponsor

Universitätsklinikum Hamburg-Eppendorf (Other)

Overall Status

Recruiting

CT.gov ID

NCT03692234

Collaborator

(none)

500

Enrollment

Location

Arms

59.3

Anticipated Duration (Months)

8.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Deficiency; Diet	Dietary Supplement: 125 mg L-homoarginine Other: placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomized double-blind placebo controlledrandomized double-blind placebo controlled

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

Homoarginine in Stroke (HiS) Study

Actual Study Start Date :

Aug 22, 2018

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: placebo placebo capsules containing lactose - oral once weekly administration for six month	Other: placebo capsules for oral supplementation
Active Comparator: homoarginine 125 mg L-homoarginine supplement - oral once weekly administration for six month	Dietary Supplement: 125 mg L-homoarginine capsules for oral supplementation

Arm

Intervention/Treatment

Placebo Comparator: placebo

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

Other: placebo

capsules for oral supplementation

Active Comparator: homoarginine

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

Dietary Supplement: 125 mg L-homoarginine

capsules for oral supplementation

Outcome Measures

Primary Outcome Measures

Homoarginine serum concentration [six month]
Normalization of homoarginine serum concentration to levels >2.1 umol/L.

Secondary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center Hamburg	Hamburg		Germany	20246

Sponsors and Collaborators

Universitätsklinikum Hamburg-Eppendorf

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Universitätsklinikum Hamburg-Eppendorf

ClinicalTrials.gov Identifier:

NCT03692234

Other Study ID Numbers:

Homoarginine in Stroke

First Posted:

Oct 2, 2018

Last Update Posted:

Jul 2, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Universitätsklinikum Hamburg-Eppendorf

homoarginine

Additional relevant MeSH terms:

Malnutrition

Study Results

No Results Posted as of Jul 2, 2021