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Completed

NCT Number: NCT01704183

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

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.

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Key information

Conditions

Relapse-Remitting Multiple Sclerosis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Neuro Center, Kuopio University Hospital, Kuopio, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. change in heart rate variability

    Time frame: prior medication vs initiation vs 3 month

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Registry information

Acronym: FingoHRV

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 11, 2012
Registry last updated
May 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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