Relapse-remitting Multiple Sclerosis
Conditions
Keywords
relapse-remitting multiple sclerosis, heart rate variability, fingolimod, cardiac autonomic regulation
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Kuopio University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in heart rate variability | prior medication vs initiation vs 3 month |
Countries
Finland
Outcome results
None listed