COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01704183
Recruitment Status : Completed
First Posted : October 11, 2012
Last Update Posted : May 8, 2014
Information provided by (Responsible Party):
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.

Condition or disease
Relapse-remitting Multiple Sclerosis

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 27 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Fingolimod on the Cardiac Autonomic Regulation in Patients With Multiple Sclerosis
Study Start Date : December 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Fingolimod

Primary Outcome Measures :
  1. change in heart rate variability [ Time Frame: prior medication vs initiation vs 3 month ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Neurological clinic

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01704183

Layout table for location information
Neuro Center, Kuopio University Hospital
Kuopio, Finland
Department of Neurology, Mikkeli Central Hospital
Mikkeli, Finland
Sponsors and Collaborators
Kuopio University Hospital
Layout table for investigator information
Study Director: 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
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Kuopio University Hospital Identifier: NCT01704183    
Other Study ID Numbers: IIT-2012-SS
2012-002694-66 ( EudraCT Number )
First Posted: October 11, 2012    Key Record Dates
Last Update Posted: May 8, 2014
Last Verified: May 2014
Keywords provided by Kuopio University Hospital:
relapse-remitting multiple sclerosis
heart rate variability
cardiac autonomic regulation
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Disease Attributes