Atrial FibrillationESA-AFNCT04593498
Excessive Supraventricular Activity and Atrial Fibrillation
An observational study of Atrial Fibrillation and Atrial Flutter, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The aim of the proposed study is to determine if individuals with excessive supraventricular ectopic activity (ESVEA) on Holter recording should be subjected to prolonged screening with Event loop recorder in order to detect previously undiagnosed Atrial fibrillation / flutter. Read more about this study
- Who is it for?
- Ages 70 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter, Supraventricular Beat, Premature
- What is being tested?
- Holter recording, Echocardiography (Echo) and Blood sample
- How many people
- 250 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2022to 15 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 to 89 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Individuals who have underwent Holter recording at Danderyd hospital after 2022.
Who may be able to join
- Patients with at least 30 supraventricular extra systole (SVES)/h or a supraventricular run of at least 20 beats on a Holter recording.
Who cannot join
- Age < 70 years, >89 years Atrial fibrillation / flutter Lifelong treatment with oral anticoagulant Patients with implantable cardiac device Congestive heart failure (CHF) with Ejection fraction (EF) ≤ 30% Severe valvular heart disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Danderyd Hospital
Stockholm
Johan Engdahl, johan.engdahl@regionstockholm.se
Mehrnoosh Hossein beky, mehr.hossein-beky@regionstockholm.se
About this study
Official title: Detection of Atrial Fibrillation in Patients With Excessive Supraventricular Activity
The aim of the proposed study is to determine if individuals with excessive supraventricular ectopic activity (ESVEA) on Holter recording should be subjected to prolonged screening with Event loop recorder in order to detect previously undiagnosed Atrial fibrillation / flutter. Other biomarkers such as plasma biomarkers, high-end echocardiography and assessment of blood pressure and atrial stiffness will be studied and compared in ESVEA and control group as well as progression of atrial cardiomyopathy in ESVEA patients.
Read the detailed description
Excessive supraventricular ectopic activities (ESVEA) are a common finding on long-term ECG recordings and have a connection to atrial cardiomyopathy, incident AF, stroke and mortality.
Holter recording from 2022 preformed at Danderyd hospital will be screened in order to identify 125 recordings with ESVEA, defined as at least 30 atrial ectopic beats/hour or a supraventricular run of at least 20 consecutive beats. Participants fulfilling eligibility criteria will be offered prolonged AF screening with continuous holter recording during 14 days. A matched control group (125 participants) without ESVEA will also be screened using same method.
Cardiovascular data from medical records will be collected in order to obtain information regarding co-morbidities and being able to assess CHA2DS2-VASC score. Participants will be asked to fill in a questionnaire.
Samples of blood will be collected at index time, after 21± 3 months for further analysis with the aim of identifying biomarkers for atrial fibrillation. During these two time periods echocardiography, 24 hour ambulatory blood pressure monitoring and assessment af artery stiffness with Arteriograph will also be preformed.
The study population will after 21± 3 months be subjected to renewed screening with Holter in order to examine the persistence of excessive supraventricular activity.
Four years after the completion of screening visits, data from patient records and information thorough telephone interview and/or data from Swedish Patient Register, Swedish Dispensed Drug Register will be collected
- Conditions
- Atrial Fibrillation, Atrial Flutter, Supraventricular Beat, Premature, Premature Supraventricular Beats, Premature Atrial Complex, Extrasystole, Atrial
- Being tested
- Holter recording, Echocardiography (Echo), Blood sample, 24 hour ambulatory blood pressure monitoring And Arteriograph
- Keywords
- Excessive supraventricular ectopic activity
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter, Atrial Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holter recordingDiagnostic test
Holter recording with Zenicor Flex ECG during 14 days.
Echocardiography (Echo)Diagnostic test
Echocardiography: Comprehensive transthoracic echocardiography with special focus on atrial dimension and function.
Blood sampleDiagnostic test
Blood sample: 2 x 10 ml EDTA plasma sampled from venous blood at index and at 21 months. Troponin T, NTproBNP, Na, K, Creatinine. Sample for Biobank for future analysis.
24 hour ambulatory blood pressure monitoring And ArteriographDiagnostic test
To assess artery stiffness.
| Study group | Role | What they receive |
|---|---|---|
| ESVEA | ESVEA (Excessive supraventricular ectopic activity): Participants with at least 30 supraventricular extra systole (SVES)/h or a supraventricular run of at least 20 beats. Receives: Diagnostic Test: Holter recording; Diagnostic Test: Echocardiography (Echo); Diagnostic Test: Blood sample; Diagnostic Test: 24 hour ambulatory blood pressure monitoring And Arteriograph | |
| Non-ESVEA | Participants not meeting inclusion criteria Receives: Diagnostic Test: Holter recording; Diagnostic Test: Echocardiography (Echo); Diagnostic Test: Blood sample; Diagnostic Test: 24 hour ambulatory blood pressure monitoring And Arteriograph |
What is being measured
The primary outcome is the main question the study is designed to answer.
atrial fibrillation yield in extended ECG screening among patients with ESVEA on Holter recording as compared to patients without ESVEA.
Proportion of patients with at least one episode of atrial fibrillation with a duration of at least 30 seconds among patients with ESVEA on Holter recording as compared to patients without ESVEA.
Measured: 10-14 days
Secondary outcomes (7)
the clinical development of atrial fibrillation subtype in patients diagnosed with atrial fibrillation.
Presence of paroxysmal or permanent atrial fibrillation on follow-up.
Measured: 2 years
Temporal development of ESVEA and atrial cardiomyopathy on repeated Holter recordings.
Comparison of burden of supraventricular extrasystolic beats and number of episodes and duration of longest episode of supraventricular tachycardia.
Measured: 2 years
Temporal development of several blood biomarkers with a possible relation to atrial cardiomyopathy in patients with and without ESVEA.
Explorative sequential analysis of several blood biomarkers using PEA:
Measured: 2 years
association between plasma biomarkers and the development of atrial fibrillation in patients with ESVEA.
Comparison of biomarker profile in patients diagnosed with atrial fibrillation and patients not diagnosed with atrial fibrillation.
Measured: 2 years
Association between ESVEA, atrial fibrillation and other relevant comorbidities such as stroke, heart failure and major bleeding as well as mortality.
Long-term data on incident stroke, heart failure, major bleedning and mortality compared between ESVEA- and non-ESVEA groups.
Measured: 4 years or longer
echocardiographic parameters in relation to ESVEA and/or AF.
Comparison of echocardiographic parameters with focus on atrial dimension and function compared between ESVEA and non-ESVEA group.
Measured: 2 years
Artrial stiffness in relation to ESVEA and/or AF.
Comparison of artrial stiffness and blood pressure
Measured: 2 yeras
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start1 Nov 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion15 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Danderyd Hospital
- Responsible party
- Principal investigator, Johan Engdahl, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593498
- Sponsor's protocol ID
- ESA_AF2018
- Acronym
- ESA-AF
- Status last verified
- Mar 2024
- First submitted
- 13 Oct 2020
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Atrial Fibrillation in Patients With Excessive Supraventricular Activity
- ClinicalTrials.gov ID
- NCT04593498
- Acronym / sponsor ID
- ESA-AF / ESA_AF2018
- Conditions
- Atrial Fibrillation, Atrial Flutter, Supraventricular Beat, Premature, Premature Supraventricular Beats, Premature Atrial Complex, Extrasystole, Atrial
- Keywords
- Excessive supraventricular ectopic activity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Danderyd Hospital
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 15 Feb 2028 (estimated)
- First posted
- 20 Oct 2020 (actual)
- 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 aim of the proposed study is to determine if individuals with excessive supraventricular ectopic activity (ESVEA) on Holter recording should be subjected to prolonged screening with Event loop recorder in order to detect previously undiagnosed Atrial fibrillation / flutter. Other biomarkers such as plasma biomarkers, high-end echocardiography and assessment of blood pressure and atrial stiffness will be studied and compared in ESVEA and control group as well as progression of atrial cardiomyopathy in ESVEA patients.
Detailed description
Excessive supraventricular ectopic activities (ESVEA) are a common finding on long-term ECG recordings and have a connection to atrial cardiomyopathy, incident AF, stroke and mortality.
Holter recording from 2022 preformed at Danderyd hospital will be screened in order to identify 125 recordings with ESVEA, defined as at least 30 atrial ectopic beats/hour or a supraventricular run of at least 20 consecutive beats. Participants fulfilling eligibility criteria will be offered prolonged AF screening with continuous holter recording during 14 days. A matched control group (125 participants) without ESVEA will also be screened using same method.
Cardiovascular data from medical records will be collected in order to obtain information regarding co-morbidities and being able to assess CHA2DS2-VASC score. Participants will be asked to fill in a questionnaire.
Samples of blood will be collected at index time, after 21± 3 months for further analysis with the aim of identifying biomarkers for atrial fibrillation. During these two time periods echocardiography, 24 hour ambulatory blood pressure monitoring and assessment af artery stiffness with Arteriograph will also be preformed.
The study population will after 21± 3 months be subjected to renewed screening with Holter in order to examine the persistence of excessive supraventricular activity.
Four years after the completion of screening visits, data from patient records and information thorough telephone interview and/or data from Swedish Patient Register, Swedish Dispensed Drug Register will be collected
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESVEA | – | Diagnostic Test: Holter recording, Diagnostic Test: Echocardiography (Echo), Diagnostic Test: Blood sample, Diagnostic Test: 24 hour ambulatory blood pressure monitoring And ArteriographESVEA (Excessive supraventricular ectopic activity): Participants with at least 30 supraventricular extra systole (SVES)/h or a supraventricular run of at least 20 beats. |
| Non-ESVEA | – | Diagnostic Test: Holter recording, Diagnostic Test: Echocardiography (Echo), Diagnostic Test: Blood sample, Diagnostic Test: 24 hour ambulatory blood pressure monitoring And ArteriographParticipants not meeting inclusion criteria |
Who may qualify
- Ages
- 70 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Individuals who have underwent Holter recording at Danderyd hospital after 2022.
Key inclusion criteria (1 listed)
- Patients with at least 30 supraventricular extra systole (SVES)/h or a supraventricular run of at least 20 beats on a Holter recording.
Key exclusion criteria (1 listed)
- Age < 70 years, >89 years Atrial fibrillation / flutter Lifelong treatment with oral anticoagulant Patients with implantable cardiac device Congestive heart failure (CHF) with Ejection fraction (EF) ≤ 30% Severe 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 |
|---|---|---|
| Holter recordingHolter recording with Zenicor Flex ECG during 14 days. | Diagnostic test | ESVEA, Non-ESVEA |
| Echocardiography (Echo)Echocardiography: Comprehensive transthoracic echocardiography with special focus on atrial dimension and function. | Diagnostic test | ESVEA, Non-ESVEA |
| Blood sampleBlood sample: 2 x 10 ml EDTA plasma sampled from venous blood at index and at 21 months. Troponin T, NTproBNP, Na, K, Creatinine. Sample for Biobank for future analysis. | Diagnostic test | ESVEA, Non-ESVEA |
| 24 hour ambulatory blood pressure monitoring And ArteriographTo assess artery stiffness. | Diagnostic test | ESVEA, Non-ESVEA |
Primary outcome
atrial fibrillation yield in extended ECG screening among patients with ESVEA on Holter recording as compared to patients without ESVEA.
Time frame: 10-14 days
Proportion of patients with at least one episode of atrial fibrillation with a duration of at least 30 seconds among patients with ESVEA on Holter recording as compared to patients without ESVEA.
7 secondary outcomes
the clinical development of atrial fibrillation subtype in patients diagnosed with atrial fibrillation.
Time frame: 2 years
Temporal development of ESVEA and atrial cardiomyopathy on repeated Holter recordings.
Time frame: 2 years
Temporal development of several blood biomarkers with a possible relation to atrial cardiomyopathy in patients with and without ESVEA.
Time frame: 2 years
association between plasma biomarkers and the development of atrial fibrillation in patients with ESVEA.
Time frame: 2 years
Association between ESVEA, atrial fibrillation and other relevant comorbidities such as stroke, heart failure and major bleeding as well as mortality.
Time frame: 4 years or longer
echocardiographic parameters in relation to ESVEA and/or AF.
Time frame: 2 years
Artrial stiffness in relation to ESVEA and/or AF.
Time frame: 2 yeras
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
RecruitingObservational study
AI-Based Cardiac Analysis Using 12-Lead and 1-Lead ECG
Heart Failure, Atrial Fibrillation (AF)
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Not yet recruiting
CATCH AF - Atrial Fibrillation Detection in Cryptogenic Stroke
Atrial Fibrillation (AF)
Active, not recruiting
ARIADNE Clinical Trial
Persistent Atrial Fibrillation
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Atrial Flutter, run by Karolinska Institutet at 1 site 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 1 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: looking for participants now, as of the sponsor's last update on 6 Mar 2024. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johan Engdahl (0046812358242, johan.engdahl@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
atrial fibrillation yield in extended ECG screening among patients with ESVEA on Holter recording as compared to patients without ESVEA. (time frame: 10-14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2024.