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NCT Number: NCT04593498

Excessive Supraventricular Activity and Atrial Fibrillation

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.

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Key information

Age range

70 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Holter recording

Diagnostic 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 sample

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

Diagnostic Test

To assess artery stiffness.

Primary outcomes

  1. 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.

Secondary outcomes

  1. the clinical development of atrial fibrillation subtype in patients diagnosed with atrial fibrillation.

    Time frame: 2 years

    Presence of paroxysmal or permanent atrial fibrillation on follow-up.

  2. Temporal development of ESVEA and atrial cardiomyopathy on repeated Holter recordings.

    Time frame: 2 years

    Comparison of burden of supraventricular extrasystolic beats and number of episodes and duration of longest episode of supraventricular tachycardia.

  3. Temporal development of several blood biomarkers with a possible relation to atrial cardiomyopathy in patients with and without ESVEA.

    Time frame: 2 years

    Explorative sequential analysis of several blood biomarkers using PEA:

  4. association between plasma biomarkers and the development of atrial fibrillation in patients with ESVEA.

    Time frame: 2 years

    Comparison of biomarker profile in patients diagnosed with atrial fibrillation and patients not diagnosed with atrial fibrillation.

  5. 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

    Long-term data on incident stroke, heart failure, major bleedning and mortality compared between ESVEA- and non-ESVEA groups.

  6. echocardiographic parameters in relation to ESVEA and/or AF.

    Time frame: 2 years

    Comparison of echocardiographic parameters with focus on atrial dimension and function compared between ESVEA and non-ESVEA group.

  7. Artrial stiffness in relation to ESVEA and/or AF.

    Time frame: 2 yeras

    Comparison of artrial stiffness and blood pressure

Study contacts

Contact information is provided by the study sponsor or research team.

Johan Engdahl

CONTACT

[email protected]

0046812358242

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Danderyd Hospital

Registry information

Official study title

Detection of Atrial Fibrillation in Patients With Excessive Supraventricular Activity

Acronym: ESA-AF

Important dates

Study start
2022
Primary completion
2026
Study completion
2028
First posted
Oct 20, 2020
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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