Excessive Supraventricular Activity and Atrial Fibrillation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age70-89
SponsorKarolinska Institutet

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Individuals who have underwent Holter recording at Danderyd hospital after 2022.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: ESVEA4 interventions
Group B: Non-ESVEA4 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
10-14 days

Secondary outcomes

1

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

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

Time frame
2 years
2

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.

Time frame
2 years
3

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:

Time frame
2 years
4

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.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karolinska Institutet

Lead sponsor

Danderyd Hospital

Collaborator