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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002694-66 | EudraCT Number |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| change in heart rate variability | prior medication vs initiation vs 3 month |
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Inclusion Criteria:
Exclusion Criteria:
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Neurological clinic
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| Name | Affiliation | Role |
|---|---|---|
| Sakari Simula, MD, PhD | Mikkeli Central Hospital, Department of Neurology | Study Director |
| Päivi Hartikainen, MD, PhD | Kuopio University Hospital, Neuro Center | Study Director |
| Juha Hartikainen, MD, PhD | Kuopio University Hospital, Heart Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuro Center, Kuopio University Hospital | Kuopio | Finland | ||||
| Department of Neurology, Mikkeli Central Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27919506 | Derived | Simula S, Laitinen TP, Laitinen TM, Hartikainen P, Hartikainen JE. Heart rate variability predicts the magnitude of heart rate decrease after fingolimod initiation. Mult Scler Relat Disord. 2016 Nov;10:86-89. doi: 10.1016/j.msard.2016.09.012. Epub 2016 Sep 30. | |
| 26362903 | Derived | Simula S, Laitinen T, Laitinen TM, Tarkiainen T, Hartikainen P, Hartikainen JE. Effect of fingolimod on cardiac autonomic regulation in patients with multiple sclerosis. Mult Scler. 2016 Jul;22(8):1080-5. doi: 10.1177/1352458515604384. Epub 2015 Sep 11. |
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| Mikkeli |
| Finland |
| 26092537 | Derived | Simula S, Laitinen T, Laitinen TM, Tarkiainen T, Hartikainen JE, Hartikainen P. Effects of Three Months Fingolimod Therapy on Heart Rate. J Neuroimmune Pharmacol. 2015 Dec;10(4):651-4. doi: 10.1007/s11481-015-9619-8. Epub 2015 Jun 20. |