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

May 7, 2014 updated by: Kuopio University Hospital

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

27

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Kuopio, Finland
        • Neuro Center, Kuopio University Hospital
      • Mikkeli, Finland
        • Department of Neurology, Mikkeli Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Neurological clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in heart rate variability
Time Frame: prior medication vs initiation vs 3 month
prior medication vs initiation vs 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuopio University Hospital

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

October 8, 2012

First Submitted That Met QC Criteria

October 10, 2012

First Posted (Estimate)

October 11, 2012

Study Record Updates

Last Update Posted (Estimate)

May 8, 2014

Last Update Submitted That Met QC Criteria

May 7, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT-2012-SS
  • 2012-002694-66 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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