Arterial HypertensionNCT02041832
Detection of Subclinical Atrial Fibrillation in High Risk Patients Using Implantable Loop Recorder
A study testing Conventional Holter monitoring and Implantable loop recorder in people with Arterial Hypertension and Diabetes Mellitus, run by Axel Brandes at 1 site in Denmark.
Trial summary
Using implantable loop recorder the investigators wish to detect atrial fibrillation in high risk patients and compare it to the results using conventional Holter monitoring. The hypothesis is that 10-15% of high risk patients have subclinical atrial fibrillation. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Arterial Hypertension, Diabetes Mellitus
- What is being tested?
- Conventional Holter monitoring and Implantable loop recorder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2013to Sep 2016
- Phase
- Interventional
- 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 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age > 65 years
- arterial hypertension (at least dual treatment)
- diabetes mellitus (oral antidiabetics or insulin)
Who cannot join
- known atrial fibrillation
- ischaemic heart disease
- Current anticoagulation treatment
- Ejection fraction <45 %
- significant valvular heart disease
- previous stroke/transient ischemic attack
Show all 9Show fewer
- peripheral arterial disease
- end stage renal disease
- thyreotoxicosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of Subclinical Atrial Fibrillation in High Risk Patients (> 65 Years, Hypertension, Diabetes Mellitus) Using Implantable Loop Recorder
Using implantable loop recorder the investigators wish to detect atrial fibrillation in high risk patients and compare it to the results using conventional Holter monitoring. The hypothesis is that 10-15% of high risk patients have subclinical atrial fibrillation. The investigators want to detect those people so they can receive appropriate anticoagulation treatment. The patients will get a comprehensive workup including ecg, echocardiography and blood tests.
- Conditions
- Arterial Hypertension, Diabetes Mellitus
- Being tested
- Conventional Holter monitoring, Implantable loop recorder
- Medical subject headings
- Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Holter monitoringOther
Patients undergo 72h Holter monitoring
Implantable loop recorderDevice
Also called REVEAL XT
Implantation of loop recorder with follow-up by remote monitoring
| Study group | Role | What they receive |
|---|---|---|
| Holter monitoring | Other | Screening of patients with older age, arterial hypertension and diabetes for paroxysmal atrial fibrillation by using conventional Holter monitoring Receives: Other: Conventional Holter monitoring |
| Implantable loop recorder | Other | Screening of patients with older age, arterial hypertension and diabetes mellitus for paroxysmal atrial fibrillation by using an implantable loop recorder Receives: Device: Implantable loop recorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
First episode of atrial fibrillation
Measured: 1 year
Secondary outcomes (1)
Correlation between echocardiographic parameters and incidence of atrial fibrillation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startOct 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arterial HypertensionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Axel Brandes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Axel Brandes, Odense University Hospital
- Investigators
- Axel Brandes, Assoc. Prof., Study director, Odense University Hospital/University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041832
- Sponsor's protocol ID
- ILR-Afib-study
- Other IDs
- S-20130062
- Status last verified
- Sep 2016
- First submitted
- 28 Nov 2013
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Philippsen TJ, Christensen LS, Hansen MG, Dahl JS, Brandes A. Detection of Subclinical Atrial Fibrillation in High-Risk Patients Using an Insertable Cardiac Monitor. JACC Clin Electrophysiol. 2017 Dec 26;3(13):1557-1564. doi: 10.1016/j.jacep.2017.06.020. Epub 2017 Nov 6.
PubMed 29759838
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Subclinical Atrial Fibrillation in High Risk Patients (> 65 Years, Hypertension, Diabetes Mellitus) Using Implantable Loop Recorder
- ClinicalTrials.gov ID
- NCT02041832
- Acronym / sponsor ID
- ILR-Afib-study
- Conditions
- Arterial Hypertension, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Axel BrandesUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 22 Jan 2014 (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.
Using implantable loop recorder the investigators wish to detect atrial fibrillation in high risk patients and compare it to the results using conventional Holter monitoring. The hypothesis is that 10-15% of high risk patients have subclinical atrial fibrillation. The investigators want to detect those people so they can receive appropriate anticoagulation treatment. The patients will get a comprehensive workup including ecg, echocardiography and blood tests.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Holter monitoring | Other | Other: Conventional Holter monitoringScreening of patients with older age, arterial hypertension and diabetes for paroxysmal atrial fibrillation by using conventional Holter monitoring |
| Implantable loop recorder | Other | Device: Implantable loop recorderScreening of patients with older age, arterial hypertension and diabetes mellitus for paroxysmal atrial fibrillation by using an implantable loop recorder |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- age > 65 years
- arterial hypertension (at least dual treatment)
- diabetes mellitus (oral antidiabetics or insulin)
Key exclusion criteria (9 listed)
- known atrial fibrillation
- ischaemic heart disease
- Current anticoagulation treatment
- Ejection fraction <45 %
- significant valvular heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Holter monitoringPatients undergo 72h Holter monitoring | Other | Holter monitoring |
| Implantable loop recorderAlso: REVEAL XTImplantation of loop recorder with follow-up by remote monitoring | Device | Implantable loop recorder |
Primary outcome
First episode of atrial fibrillation
Time frame: 1 year
1 secondary outcome
Correlation between echocardiographic parameters and incidence of atrial fibrillation
Time frame: 1 year
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 28 Sep 2016.
- Derived from this study: PubMed 29759838Philippsen TJ, Christensen LS, Hansen MG, Dahl JS, Brandes A. Detection of Subclinical Atrial Fibrillation in High-Risk Patients Using an Insertable Cardiac Monitor. JACC Clin Electrophysiol. 2017 Dec 26;3(13):1557-1564. doi: 10.1016/j.jacep.2017.06.020. Epub 2017 Nov 6.
Related trials for Arterial Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
Axel Brandes, Assoc. Prof. study director
Odense University Hospital/University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Holter monitoring and Implantable loop recorder in people with Arterial Hypertension and Diabetes Mellitus, run by Axel Brandes at 1 site in Denmark.
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 3 inclusion and 9 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 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
First episode of atrial fibrillation (time frame: 1 year). 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 NCT02041832, which also lists 1 linked publication.
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 28 Sep 2016.