Effects of Fingolimod on Heart Rhythm and Heart Rate Variability in Patients With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— FINGORHYMS  

Official title:

FINGORHYMS - Effects of Fingolimod on Heart Rhythm and Heart Rate Variability in Patients With Multiple Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03216915
• Other study ID #: PV5273
• Status: Recruiting
• Start date: June 1, 2013
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2019
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Ruken Özge Akbulak
• Phone: +49 (0) 40 7410 59471
• Email: r.akbulak[@]uke.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The current study sought to prolong the observational interval after initiating medication with fingolimod and to measure the long-term effects of fingolimod on HR and HRV as an indicator of autonomic nervous system function in patients with RR-MS.

Description:

Fingolimod (Gilenya®; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA) is a novel oral disease-modifying therapy that acts as a sphingosine-1-phosphate (S1P) receptor agonist and reduces the recirculation of lymphocytes to blood and peripheral tissues, including inflammatory lesions.

A critical part of fingolimod therapy still remains in the screening and initiation phases because of the risk of cardiac events. It is well known that the first dose of fingolimod is associated with a decrease in heart rate (HR) and slowing of atrioventricular (AV) conduction. Patients were continuously observed for a minimum of 6 hours after taking fingolimod. Because resurgence of heart rate began at 6 hours, the actual recommendation for observation is only 6 hours. Data about the effect of fingolimod after this time period is lacking.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ability to provide written informed consent in accordance with Good Epidemiological Practice and local legislation

• Individuals over the age of 18 years

• Patients with relapsing-remitting forms of multiple sclerosis who were considered eligible for fingolimod treatment on a clinical basis.

Exclusion Criteria:

• Insufficient knowledge of the German language (not able to understand and write the German language)

• Physical or psychological incapability to take part in the study

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Gilenya®; Novartis Pharmaceuticals Corporation
This is a prospective cohort-based study. Eligible are all patients planned for a treatment with fingolimod at the Hamburg University Hospital who are willing and able to participate in an observational study.

Locations

Country	Name	City	State
Germany	University Medical Hospital Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of AF	Recurrence of sustained atrial fibrillation (>30 seconds) after atrial fibrillation ablation	6 months follow up