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

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ClinicalTrials.gov Identifier: NCT01704183
Recruitment Status : Completed
First Posted : October 11, 2012
Last Update Posted : May 8, 2014
Sponsor:
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.

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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





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

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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
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

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 ClinicalTrials.gov identifier (NCT number): NCT01704183


Locations
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Finland
Neuro Center, Kuopio University Hospital
Kuopio, Finland
Department of Neurology, Mikkeli Central Hospital
Mikkeli, Finland
Sponsors and Collaborators
Kuopio University Hospital
Investigators
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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 ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT01704183     History of Changes
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
fingolimod
cardiac autonomic regulation
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Recurrence
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Disease Attributes
Fingolimod Hydrochloride
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs