Relapse-remitting Multiple SclerosisFingoHRVNCT01704183
Effect of Fingolimod on the Cardiac Autonomic Regulation in Patients With Multiple Sclerosis
An observational study of Relapse-remitting Multiple Sclerosis, run by Kuopio University Hospital at 2 sites in Finland.
Trial summary
The purpose of this study is to study the effect of fingolimod on cardiac autonomic regulation in patients with relapse-remitting multiple sclerosis. This will be done by measuring heart rate variability from the 24-hour Holter recording and myocardial ventricular repolarisation patterns from the 12-lead… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapse-remitting Multiple Sclerosis
- How many people
- 27 participants
- Where
- 2 sitesFinland
- Study dates
- Dec 2012to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Neurological clinic
Who may be able to join
- Age 18 - 65 years
- Understands the proposed research and actions to be taken
- The written informed consent has given
- clinical indication to fingolimod-treatment
Who cannot join
- Patient refuses
- Patient takes or has taken part in other clinical drug trial during the last month
- No clinical indication to the use of fingolimod
- Contraindication to the use of fingolimod
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Neuro Center, Kuopio University Hospital
Kuopio
Department of Neurology, Mikkeli Central Hospital
Mikkeli
About this study
The purpose of this study is to study the effect of fingolimod on cardiac autonomic regulation in patients with relapse-remitting multiple sclerosis.
This will be done by measuring heart rate variability from the 24-hour Holter recording and myocardial ventricular repolarisation patterns from the 12-lead electrocardiogram tracings.
The fingolimod treatment is prescribed according to the accepted drug label.
Read the detailed description
The study will include 30 relapse-remitting multiple sclerosis patients. Assessments of heart rate variability and myocardial ventricular repolarisation pattern will be done 1) before fingolimod, 2) first day of fingolimod 3) after 3 months use and 4) after 12 months use of fingolimod.
- Conditions
- Relapse-remitting Multiple Sclerosis
- Keywords
- relapse-remitting multiple sclerosis, heart rate variability, fingolimod, cardiac autonomic regulation
What is being measured
The primary outcome is the main question the study is designed to answer.
change in heart rate variability
Measured: prior medication vs initiation vs 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startDec 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Relapse-remitting Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sakari Simula, MD, PhD, Study director, Mikkeli Central Hospital, Department of NeurologyPäivi Hartikainen, MD, PhD, Study director, Kuopio University Hospital, Neuro CenterJuha Hartikainen, MD, PhD, Study director, Kuopio University Hospital, Heart Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704183
- Sponsor's protocol ID
- IIT-2012-SS
- Other IDs
- 2012-002694-66
- Acronym
- FingoHRV
- Status last verified
- May 2014
- First submitted
- 8 Oct 2012
- Last updated
- 8 May 2014
- Results posted
- No
Publications
Simula S, Laitinen TP, Laitinen TM, Hartikainen P, Hartikainen JE. Heart rate variability predicts the magnitude of heart rate decrease after fingolimod initiation. Mult Scler Relat Disord. 2016 Nov;10:86-89. doi: 10.1016/j.msard.2016.09.012. Epub 2016 Sep 30.
PubMed 27919506Simula S, Laitinen T, Laitinen TM, Tarkiainen T, Hartikainen P, Hartikainen JE. Effect of fingolimod on cardiac autonomic regulation in patients with multiple sclerosis. Mult Scler. 2016 Jul;22(8):1080-5. doi: 10.1177/1352458515604384. Epub 2015 Sep 11.
PubMed 26362903Simula S, Laitinen T, Laitinen TM, Tarkiainen T, Hartikainen JE, Hartikainen P. Effects of Three Months Fingolimod Therapy on Heart Rate. J Neuroimmune Pharmacol. 2015 Dec;10(4):651-4. doi: 10.1007/s11481-015-9619-8. Epub 2015 Jun 20.
PubMed 26092537
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fingolimod on the Cardiac Autonomic Regulation in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01704183
- Acronym / sponsor ID
- FingoHRV / IIT-2012-SS
- Conditions
- Relapse-remitting Multiple Sclerosis
- Keywords
- relapse-remitting multiple sclerosis, heart rate variability, fingolimod, cardiac autonomic regulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 11 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to study the effect of fingolimod on cardiac autonomic regulation in patients with relapse-remitting multiple sclerosis.
This will be done by measuring heart rate variability from the 24-hour Holter recording and myocardial ventricular repolarisation patterns from the 12-lead electrocardiogram tracings.
The fingolimod treatment is prescribed according to the accepted drug label.
Detailed description
The study will include 30 relapse-remitting multiple sclerosis patients. Assessments of heart rate variability and myocardial ventricular repolarisation pattern will be done 1) before fingolimod, 2) first day of fingolimod 3) after 3 months use and 4) after 12 months use of fingolimod.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Neurological clinic
Key inclusion criteria (4 listed)
- Age 18 - 65 years
- Understands the proposed research and actions to be taken
- The written informed consent has given
- clinical indication to fingolimod-treatment
Key exclusion criteria (4 listed)
- Patient refuses
- Patient takes or has taken part in other clinical drug trial during the last month
- No clinical indication to the use of fingolimod
- Contraindication to the use of fingolimod
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change in heart rate variability
Time frame: prior medication vs initiation vs 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2014.
- Derived from this study: PubMed 27919506Simula S, Laitinen TP, Laitinen TM, Hartikainen P, Hartikainen JE. Heart rate variability predicts the magnitude of heart rate decrease after fingolimod initiation. Mult Scler Relat Disord. 2016 Nov;10:86-89. doi: 10.1016/j.msard.2016.09.012. Epub 2016 Sep 30.
- Derived from this study: PubMed 26362903Simula S, Laitinen T, Laitinen TM, Tarkiainen T, Hartikainen P, Hartikainen JE. Effect of fingolimod on cardiac autonomic regulation in patients with multiple sclerosis. Mult Scler. 2016 Jul;22(8):1080-5. doi: 10.1177/1352458515604384. Epub 2015 Sep 11.
- Derived from this study: PubMed 26092537Simula S, Laitinen T, Laitinen TM, Tarkiainen T, Hartikainen JE, Hartikainen P. Effects of Three Months Fingolimod Therapy on Heart Rate. J Neuroimmune Pharmacol. 2015 Dec;10(4):651-4. doi: 10.1007/s11481-015-9619-8. Epub 2015 Jun 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sakari Simula, MD, PhD study director
Mikkeli Central Hospital, Department of Neurology
Päivi Hartikainen, MD, PhD study director
Kuopio University Hospital, Neuro Center
Juha Hartikainen, MD, PhD study director
Kuopio University Hospital, Heart Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapse-remitting Multiple Sclerosis, run by Kuopio University Hospital at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in heart rate variability (time frame: prior medication vs initiation vs 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01704183, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2014.