Homoarginine Supplementation in Patients After Stroke (HiS)

Universitätsklinikum Hamburg-Eppendorf

Status: Unknown

Conditions: Deficiency; Diet

Treatments: Dietary Supplement: 125 mg L-homoarginine; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03692234

Homoarginine in Stroke

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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• no or withdrawn signed informed consent

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

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

Treatment:

Other: placebo

homoarginine

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: 125 mg L-homoarginine