HyperthyroidismTAMBOURINENCT01945229
Thumb-ECG Ambulant Screening for Atrial Fibrillation in Patients Treated for Hyperthyroidism (TAMBOURINE)
An observational study of Hyperthyroidism and Atrial Fibrillation, run by Karolinska Institutet at 3 sites in Sweden.
Trial summary
Background: Atrial fibrillation is a common heart rhythm disturbance affecting some 1-2% of the western population. It may cause symptoms such as irregular heartbeats, shortness of breath, and fatigue. It may also be asymptomatic (ie "silent atrial fibrillation). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hyperthyroidism, Atrial Fibrillation
- How many people
- 110 participants
- Where
- 3 sitesSweden
- Study dates
- Feb 2014to Aug 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We will screen all patients residing in the extended region around Stockholm, Sweden who have been referred and admitted to the Radiumhemmet clinic for investigation (and usually treatment) with radioiodine. As of February 2016, we will also include patients referred for treatment with antithyroid drugs at the endocrinology clinics of 1) Sahlgrenska University Hospital, Gothemburg Sweden, 2) Karolinska University Hospital, Stockholm, Sweden, 3) Danderyds Hospital, Stockholm, Sweden
Who may be able to join
- Patient is deemed suitable for treatment with radioiodine or antithyroid drugs
- Patient has a thyreotropin (TSH) value below 0,1 mIU/L, measured less than 2 weeks before inclusion
- Patient has a CHADS-VASc-score of 1 point or higher (excluding if 1 point is for female sex only)
- Patient gives written consent to participate in study
Who cannot join
- Patient has a previously known diagnosis of atrial fibrillation
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Medicine Clinic, Sahlgrenska University Hospital
Gothemburg, 41345
Endocrinology Clinik, Karolinska University Hospital
Stockholm, 17176
Medicine Clinic, Danderyds Hospital
Stockholm, 18288
About this study
Background: Atrial fibrillation is a common heart rhythm disturbance affecting some 1-2% of the western population. It may cause symptoms such as irregular heartbeats, shortness of breath, and fatigue. It may also be asymptomatic (ie "silent atrial fibrillation). In some cases, atrial fibrillation is permanent whereas in others it is sporadic. Regardless of symptoms, there is an increased risk of stroke in some patients with this condition. Novel technologies are being developed to increase detection of silent atrial fibrillation, in order to find patients who might benefit from treatment with oral anticoagulants (blood-thinning medications) in order to reduce the risk of stroke. One of these technologies is thumb-ECG, a simple way for a patient to have his or her heart rhythm reliably analyzed at home.
Hyperthyroidism (sometimes referred to as "toxic goiter") is defined as an excessive production of thyroid hormone. It is known that hyperthyroidism may cause atrial fibrillation in about 8% of cases.
Read more
Objective: To provide thumb-ECG-monitors to hyperthyroid patients before and after treating their hormonal disturbance, in order to find episodes of silent atrial fibrillation.
Design: Prospective observational study.
Hypotheses:
- Primary hypothesis: Silent atrial fibrillation is at least as common as overt atrial fibrillation in hyperthyroid patients.
- Secondary hypothesis nr 1: Atrial fibrillation continues to be more prevalent compared to the normal population even after hyperthyroidism is treated.
- Secondary hypothesis nr 2: The majority of patients with hyperthyroidism and atrial fibrillation are at increased risk of stroke and should be considered for treatment with oral anticoagulants.
- Conditions
- Hyperthyroidism, Atrial Fibrillation
- Medical subject headings
- Hyperthyroidism, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hyperthyroid patients | Patients with hyperthyroidism admitted for treatment with radioiodine or antithyroid drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of asymptomatic (silent) atrial fibrillation in hyperthyroid patients
Upon inclusion, each patient will receive a thumb-ECG-monitor to take home. He/she will register his/her heart rhythm twice daily, and can also register at will upon symptoms. This will continue for 2 weeks, after which the monitor is returned.
Measured: Upon inclusion and 2 weeks onwards
Secondary outcomes (2)
Prevalence of asymptomatic (silent) atrial fibrillation in patients treated for hyperthyroidism.
When a patient comes back to the policlinic after hyperthyroidism treatment (typically 3 months later), the same procedure is performed as upon inclusion. Thumb-ECG-monitoring is performed during a 2-week period.
Measured: Between 12 and 14 weeks after inclusion
Prevalence of risk factors for stroke in patients with atrial fibrillation
Risk factors for stroke in atrial fibrillation according to the CHADS-VASc-scoring system.
Measured: Momentary (day 1, upon inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2013 (estimated)
- Study startFeb 2014
- Primary completionAug 2020
- Study completionAug 2020
Why it stopped: Preliminary analyses of data indicated study should be terminated for futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HyperthyroidismStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Giesecke, M.D, Karolinska Institutet
- Investigators
- Mårten Rosenqvist, Prof, Study chair, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01945229
- Sponsor's protocol ID
- 3/9 B
- Acronym
- TAMBOURINE
- Status last verified
- Sep 2020
- First submitted
- 13 Sep 2013
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Frost L, Vestergaard P, Mosekilde L. Hyperthyroidism and risk of atrial fibrillation or flutter: a population-based study. Arch Intern Med. 2004 Aug 9-23;164(15):1675-8. doi: 10.1001/archinte.164.15.1675.
PubMed 15302638Osman F, Franklyn JA, Holder RL, Sheppard MC, Gammage MD. Cardiovascular manifestations of hyperthyroidism before and after antithyroid therapy: a matched case-control study. J Am Coll Cardiol. 2007 Jan 2;49(1):71-81. doi: 10.1016/j.jacc.2006.08.042. Epub 2006 Dec 13.
PubMed 17207725Metso S, Auvinen A, Salmi J, Huhtala H, Jaatinen P. Increased long-term cardiovascular morbidity among patients treated with radioactive iodine for hyperthyroidism. Clin Endocrinol (Oxf). 2008 Mar;68(3):450-7. doi: 10.1111/j.1365-2265.2007.03064.x. Epub 2007 Oct 17.
PubMed 17941909Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH, Hindricks G, Kirchhof P; ESC Committee for Practice Guidelines (CPG). 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Eur Heart J. 2012 Nov;33(21):2719-47. doi: 10.1093/eurheartj/ehs253. Epub 2012 Aug 24. No abstract available.
PubMed 22922413
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thumb-ECG Ambulant Screening for Atrial Fibrillation in Patients Treated for Hyperthyroidism (TAMBOURINE)
- ClinicalTrials.gov ID
- NCT01945229
- Acronym / sponsor ID
- TAMBOURINE / 3/9 B
- Conditions
- Hyperthyroidism, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Preliminary analyses of data indicated study should be terminated for futility
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Aug 2020 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 18 Sep 2013 (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.
Background: Atrial fibrillation is a common heart rhythm disturbance affecting some 1-2% of the western population. It may cause symptoms such as irregular heartbeats, shortness of breath, and fatigue. It may also be asymptomatic (ie "silent atrial fibrillation). In some cases, atrial fibrillation is permanent whereas in others it is sporadic. Regardless of symptoms, there is an increased risk of stroke in some patients with this condition. Novel technologies are being developed to increase detection of silent atrial fibrillation, in order to find patients who might benefit from treatment with oral anticoagulants (blood-thinning medications) in order to reduce the risk of stroke. One of these technologies is thumb-ECG, a simple way for a patient to have his or her heart rhythm reliably analyzed at home.
Hyperthyroidism (sometimes referred to as "toxic goiter") is defined as an excessive production of thyroid hormone. It is known that hyperthyroidism may cause atrial fibrillation in about 8% of cases.
Objective: To provide thumb-ECG-monitors to hyperthyroid patients before and after treating their hormonal disturbance, in order to find episodes of silent atrial fibrillation.
Design: Prospective observational study.
Hypotheses:
- Primary hypothesis: Silent atrial fibrillation is at least as common as overt atrial fibrillation in hyperthyroid patients.
- Secondary hypothesis nr 1: Atrial fibrillation continues to be more prevalent compared to the normal population even after hyperthyroidism is treated.
- Secondary hypothesis nr 2: The majority of patients with hyperthyroidism and atrial fibrillation are at increased risk of stroke and should be considered for treatment with oral anticoagulants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperthyroid patients | – | –Patients with hyperthyroidism admitted for treatment with radioiodine or antithyroid drugs |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We will screen all patients residing in the extended region around Stockholm, Sweden who have been referred and admitted to the Radiumhemmet clinic for investigation (and usually treatment) with radioiodine. As of February 2016, we will also include patients referred for treatment with antithyroid drugs at the endocrinology clinics of 1) Sahlgrenska University Hospital, Gothemburg Sweden, 2) Karolinska University Hospital, Stockholm, Sweden, 3) Danderyds Hospital, Stockholm, Sweden
Key inclusion criteria (4 listed)
- Patient is deemed suitable for treatment with radioiodine or antithyroid drugs
- Patient has a thyreotropin (TSH) value below 0,1 mIU/L, measured less than 2 weeks before inclusion
- Patient has a CHADS-VASc-score of 1 point or higher (excluding if 1 point is for female sex only)
- Patient gives written consent to participate in study
Key exclusion criteria (1 listed)
- Patient has a previously known diagnosis of atrial fibrillation
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
Prevalence of asymptomatic (silent) atrial fibrillation in hyperthyroid patients
Time frame: Upon inclusion and 2 weeks onwards
Upon inclusion, each patient will receive a thumb-ECG-monitor to take home. He/she will register his/her heart rhythm twice daily, and can also register at will upon symptoms. This will continue for 2 weeks, after which the monitor is returned.
2 secondary outcomes
Prevalence of asymptomatic (silent) atrial fibrillation in patients treated for hyperthyroidism.
Time frame: Between 12 and 14 weeks after inclusion
Prevalence of risk factors for stroke in patients with atrial fibrillation
Time frame: Momentary (day 1, upon inclusion)
Results and safety
The study was stopped early (reason given: Preliminary analyses of data indicated study should be terminated for futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
- Background: PubMed 15302638Frost L, Vestergaard P, Mosekilde L. Hyperthyroidism and risk of atrial fibrillation or flutter: a population-based study. Arch Intern Med. 2004 Aug 9-23;164(15):1675-8. doi: 10.1001/archinte.164.15.1675.
- Background: PubMed 17207725Osman F, Franklyn JA, Holder RL, Sheppard MC, Gammage MD. Cardiovascular manifestations of hyperthyroidism before and after antithyroid therapy: a matched case-control study. J Am Coll Cardiol. 2007 Jan 2;49(1):71-81. doi: 10.1016/j.jacc.2006.08.042. Epub 2006 Dec 13.
- Background: PubMed 17941909Metso S, Auvinen A, Salmi J, Huhtala H, Jaatinen P. Increased long-term cardiovascular morbidity among patients treated with radioactive iodine for hyperthyroidism. Clin Endocrinol (Oxf). 2008 Mar;68(3):450-7. doi: 10.1111/j.1365-2265.2007.03064.x. Epub 2007 Oct 17.
- Background: PubMed 22922413Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH, Hindricks G, Kirchhof P; ESC Committee for Practice Guidelines (CPG). 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Eur Heart J. 2012 Nov;33(21):2719-47. doi: 10.1093/eurheartj/ehs253. Epub 2012 Aug 24. No abstract available.
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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.
Mårten Rosenqvist, Prof study chair
Karolinska Institutet
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperthyroidism and Atrial Fibrillation, run by Karolinska Institutet at 3 sites in Sweden.
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 1 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: stopped early, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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 was stopped early (reason given: Preliminary analyses of data indicated study should be terminated for futility). Results are not available in the source record.
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?
Prevalence of asymptomatic (silent) atrial fibrillation in hyperthyroid patients (time frame: Upon inclusion and 2 weeks onwards). 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 NCT01945229, which also lists 4 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 4 Sep 2020.