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

Relapse-remitting Multiple Sclerosis Clinical Trial

— FingoHRV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01704183
• Other study ID #: IIT-2012-SS
• Secondary ID: 2012-002694-66
• Status: Completed
• Phase: N/A
• First received: October 8, 2012
• Last updated: May 7, 2014
• Start date: December 2012
• Est. completion date: March 2014

Study information

• Verified date: May 2014
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Relapse-remitting Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
Finland	Neuro Center, Kuopio University Hospital	Kuopio
Finland	Department of Neurology, Mikkeli Central Hospital	Mikkeli

Sponsors (1)

Lead Sponsor	Collaborator
Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in heart rate variability		prior medication vs initiation vs 3 month	Yes