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

This study is currently recruiting participants.
Verified July 2017 by Universitätsklinikum Hamburg-Eppendorf
Sponsor:
ClinicalTrials.gov Identifier:
NCT03216915
First Posted: July 13, 2017
Last Update Posted: July 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
  Purpose
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.

Condition Intervention
Multiple Sclerosis Drug: Gilenya®; Novartis Pharmaceuticals Corporation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: FINGORHYMS - Effects of Fingolimod on Heart Rhythm and Heart Rate Variability in Patients With Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • Recurrence of AF [ Time Frame: 6 months follow up ]
    Recurrence of sustained atrial fibrillation (>30 seconds) after atrial fibrillation ablation


Estimated Enrollment: 100
Actual Study Start Date: June 1, 2013
Estimated Study Completion Date: December 31, 2019
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.
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
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Ruken Özge Akbulak +49 (0) 40 7410 59471 r.akbulak@uke.de
Contact: Christoph Heesen +49 (0) 40 7410 52124 heesen@uke.de

Locations
Germany
University Medical Hospital Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Christoph Heesen, MD    +49 (0) 40 7410 - 52124    heesen@uke.de   
Contact: Ruken Özge Akbulak, MD    +49 (0) 40 7410 - 59471    r.akbulak@uke.de   
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Principal Investigator: Christoph Heesen University Medical Hospital Hamburg-Eppendorf
  More Information

Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT03216915     History of Changes
Other Study ID Numbers: PV5273
First Submitted: June 22, 2017
First Posted: July 13, 2017
Last Update Posted: July 13, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Heart Rhythm
Fingolimod
autonomic nervous system
Effects of Medicinal Substance

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Fingolimod Hydrochloride
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs