Effects of Fingolimod on Heart Rhythm and Heart Rate Variability in Patients With Multiple Sclerosis (FINGORHYMS)
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|ClinicalTrials.gov Identifier: NCT03216915|
Recruitment Status : Recruiting
First Posted : July 13, 2017
Last Update Posted : January 8, 2019
|Condition or disease||Intervention/treatment|
|Multiple Sclerosis||Drug: Gilenya®; Novartis Pharmaceuticals Corporation|
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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||FINGORHYMS - Effects of Fingolimod on Heart Rhythm and Heart Rate Variability in Patients With Multiple Sclerosis|
|Actual Study Start Date :||June 1, 2013|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2020|
- 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.Other Name: Fingolimod
- Recurrence of AF [ Time Frame: 6 months follow up ]Recurrence of sustained atrial fibrillation (>30 seconds) after atrial fibrillation ablation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03216915
|Contact: Ruken Özge Akbulak||+49 (0) 40 7410 firstname.lastname@example.org|
|Contact: Christoph Heesen||+49 (0) 40 7410 email@example.com|
|Principal Investigator:||Christoph Heesen||University Medical Hospital Hamburg-Eppendorf|