Clinical trial NCT01704183: Effect of Fingolimod on the Cardiac Autonomic Regulation in Patients With Multiple Sclerosis
Official title: Effect of Fingolimod on the Cardiac Autonomic Regulation in Patients With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapse-remitting Multiple Sclerosis
Keywords: relapse-remitting multiple sclerosis
heart rate variability
fingolimod
cardiac autonomic regulation
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2012-10-11
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Neurological clinic

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.

Eligibility criteria: 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

Primary outcomes:
measure: change in heart rate variability
timeFrame: prior medication vs initiation vs 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Neuro Center, Kuopio University Hospital
city: Mikkeli
country: Finland
facility: Department of Neurology, Mikkeli Central Hospital
Study officials:
affiliation: Mikkeli Central Hospital, Department of Neurology
name: Sakari Simula, MD, PhD
role: STUDY_DIRECTOR
affiliation: Kuopio University Hospital, Neuro Center
name: Päivi Hartikainen, MD, PhD
role: STUDY_DIRECTOR
affiliation: Kuopio University Hospital, Heart Center
name: Juha Hartikainen, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.