Homoarginine Supplementation in Patients After Stroke (HiS)

June 30, 2021 updated by: Universitätsklinikum Hamburg-Eppendorf

Homoarginine in Stroke (HiS) Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chi-un Choe, MD
  • Phone Number: 22389 +49407410
  • Email: cchoe@uke.de

Study Contact Backup

  • Name: Edzard Schwedhelm, PhD
  • Phone Number: 54891 +49407410
  • Email: schwedhelm@uke.de

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • Recruiting
        • University Medical Center Hamburg
        • Contact:
          • Chi-un Che, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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  • no or withdrawn signed informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Homoarginine serum concentration
Time Frame: six month
Normalization of homoarginine serum concentration to levels >2.1 umol/L.
six month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intima-media thickness
Time Frame: 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.
six month
National Institute of Health Stroke Scale
Time Frame: 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.
six month
Modified Ranking Scale
Time Frame: 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).
six month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2018

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

July 18, 2018

First Submitted That Met QC Criteria

September 28, 2018

First Posted (Actual)

October 2, 2018

Study Record Updates

Last Update Posted (Actual)

July 2, 2021

Last Update Submitted That Met QC Criteria

June 30, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Homoarginine in Stroke

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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