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

NCT ID: NCT03216915

Last Updated: 2019-01-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-06-01
• Study Completion Date: 2020-12-31

Brief 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.

Detailed 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.

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Fingolimod

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christoph Heesen

Role: PRINCIPAL_INVESTIGATOR

University Medical Hospital Hamburg-Eppendorf

Locations

University Medical Hospital Hamburg-Eppendorf

Hamburg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Ruken Özge Akbulak

Role: CONTACT

r.akbulak@uke.de

+49 (0) 40 7410 59471

Christoph Heesen

Role: CONTACT

heesen@uke.de

+49 (0) 40 7410 52124

Facility Contacts

Christoph Heesen, MD

Role: primary

heesen@uke.de

+49 (0) 40 7410 - 52124

Ruken Özge Akbulak, MD

Role: backup

r.akbulak@uke.de

+49 (0) 40 7410 - 59471

Other Identifiers

PV5273

Identifier Type: -

Identifier Source: org_study_id