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

Kuopio University Hospital

Status: Completed

Conditions: Relapse-remitting Multiple Sclerosis

Study type: Observational

Funder types: Other

Identifiers

NCT01704183

IIT-2012-SS

2012-002694-66 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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