Multiple Sclerosis Clinical Trial
— FINGORHYMSOfficial title:
FINGORHYMS - Effects of Fingolimod on Heart Rhythm and Heart Rate Variability in Patients With Multiple Sclerosis
NCT number | NCT03216915 |
Other study ID # | PV5273 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2013 |
Est. completion date | December 31, 2020 |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Medical Hospital Hamburg-Eppendorf | Hamburg |
Lead Sponsor | Collaborator |
---|---|
Universitätsklinikum Hamburg-Eppendorf |
Germany,
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 |
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