Effect of Fingolimod on the Cardiac Autonomic Regulation in Patients With Multiple Sclerosis
- Conditions
- Relapse-remitting Multiple Sclerosis
- Registration Number
- NCT01704183
- Lead Sponsor
- Kuopio University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
- Age 18 - 65 years
- Understands the proposed research and actions to be taken
- The written informed consent has given
- clinical indication to fingolimod-treatment
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method change in heart rate variability prior medication vs initiation vs 3 month
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Neuro Center, Kuopio University Hospital
🇫🇮Kuopio, Finland
Department of Neurology, Mikkeli Central Hospital
🇫🇮Mikkeli, Finland