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

NCT03216915 | Unknown

• 1 other identifier: PV5273
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Heart Rhythm; Fingolimod; autonomic nervous system; Effects of Medicinal Substance

Outcome Measures

Primary Outcomes (1)

• Recurrence of AF

  Recurrence of sustained atrial fibrillation (\>30 seconds) after atrial fibrillation ablation

  6 months follow up

Interventions

Gilenya®; Novartis Pharmaceuticals Corporation DRUG

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.

Also known as: Fingolimod

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Hospital Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Fingolimod Hydrochloride

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sphingosine; Amino Alcohols; Alcohols; Organic Chemicals; Propylene Glycols; Glycols; Amines

Study Officials

• Christoph Heesen

  University Medical Hospital Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruken Özge Akbulak

CONTACT

+49 (0) 40 7410 59471; r.akbulak@uke.de

Christoph Heesen

CONTACT

+49 (0) 40 7410 52124; heesen@uke.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: July 13, 2017
• Study Start: June 1, 2013
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: January 8, 2019

Record last verified: 2019-01

Locations

DE (1)