Excessive Supraventricular Activity and Atrial Fibrillation

NCT ID: NCT04593498

Last Updated: 2024-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-01

Study Completion Date

2028-02-15

Brief Summary

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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

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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

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Atrial Fibrillation Atrial Flutter Supraventricular Beat, Premature Premature Supraventricular Beats Premature Atrial Complex Extrasystole, Atrial

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Holter recording

Intervention Type DIAGNOSTIC_TEST

Holter recording with Zenicor Flex ECG during 14 days.

Echocardiography (Echo)

Intervention Type DIAGNOSTIC_TEST

Echocardiography: Comprehensive transthoracic echocardiography with special focus on atrial dimension and function.

Blood sample

Intervention Type DIAGNOSTIC_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 Arteriograph

Intervention Type DIAGNOSTIC_TEST

To assess artery stiffness.

Non-ESVEA

Participants not meeting inclusion criteria

Holter recording

Intervention Type DIAGNOSTIC_TEST

Holter recording with Zenicor Flex ECG during 14 days.

Echocardiography (Echo)

Intervention Type DIAGNOSTIC_TEST

Echocardiography: Comprehensive transthoracic echocardiography with special focus on atrial dimension and function.

Blood sample

Intervention Type DIAGNOSTIC_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 Arteriograph

Intervention Type DIAGNOSTIC_TEST

To assess artery stiffness.

Interventions

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Holter recording

Holter recording with Zenicor Flex ECG during 14 days.

Intervention Type DIAGNOSTIC_TEST

Echocardiography (Echo)

Echocardiography: Comprehensive transthoracic echocardiography with special focus on atrial dimension and function.

Intervention Type DIAGNOSTIC_TEST

Blood sample

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.

Intervention Type DIAGNOSTIC_TEST

24 hour ambulatory blood pressure monitoring And Arteriograph

To assess artery stiffness.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

Patients with at least 30 supraventricular extra systole (SVES)/h or a supraventricular run of at least 20 beats on a Holter recording.

Exclusion Criteria

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
Minimum Eligible Age

70 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danderyd Hospital

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Johan Engdahl

MD, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Danderyd Hospital

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Johan Engdahl

Role: CONTACT

0046812358242

Facility Contacts

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Johan Engdahl

Role: primary

Mehrnoosh Hossein beky

Role: backup

Other Identifiers

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ESA_AF2018

Identifier Type: -

Identifier Source: org_study_id

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