Effect of Fingolimod on the Cardiac Autonomic Regulation in Patients With Multiple Sclerosis

Kuopio University Hospital27 enrolled

Overview

The purpose of this study is to study the effect of fingolimod on cardiac autonomic regulation in patients with relapse-remitting multiple sclerosis. This will be done by measuring heart rate variability from the 24-hour Holter recording and myocardial ventricular repolarisation patterns from the 12-lead electrocardiogram tracings. The fingolimod treatment is prescribed according to the accepted drug label.

The study will include 30 relapse-remitting multiple sclerosis patients. Assessments of heart rate variability and myocardial ventricular repolarisation pattern will be done 1) before fingolimod, 2) first day of fingolimod 3) after 3 months use and 4) after 12 months use of fingolimod.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Relapse-remitting Multiple Sclerosis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 - 65 years * Understands the proposed research and actions to be taken * The written informed consent has given * clinical indication to fingolimod-treatment Exclusion Criteria: * Patient refuses * Patient takes or has taken part in other clinical drug trial during the last month * No clinical indication to the use of fingolimod * Contraindication to the use of fingolimod

Locations (2)

Neuro Center, Kuopio University Hospital

Kuopio, Finland

Department of Neurology, Mikkeli Central Hospital

Mikkeli, Finland

Outcomes

Primary Outcomes

change in heart rate variability

Time frame: prior medication vs initiation vs 3 month

Data from ClinicalTrials.gov

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