Ignite Creation Date:
2024-05-06 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03216915
Status:
UNKNOWN
Last Update Posted:
2019-01-08
First Post:
2017-06-22
Brief Title:
Effects of Fingolimod on Heart Rhythm and Heart Rate Variability in Patients With Multiple Sclerosis
Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Organization:
Universitätsklinikum Hamburg-Eppendorf
Study Overview
Official Title:
FINGORHYMS - Effects of Fingolimod on Heart Rhythm and Heart Rate Variability in Patients With Multiple Sclerosis
Status:
UNKNOWN
Status Verified Date:
2019-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FINGORHYMS
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None