Excessive Supraventricular Activity and Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— ESA-AF  

Official title:

Detection of Atrial Fibrillation in Patients With Excessive Supraventricular Activity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04593498
• Other study ID #: ESA_AF2018
• Status: Recruiting
• Start date: November 1, 2022
• Est. completion date: February 15, 2028

Study information

• Verified date: March 2024
• Source: Karolinska Institutet
• Contact: Johan Engdahl
• Phone: 0046812358242
• Email: johan.engdahl[@]regionstockholm.se
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: February 15, 2028
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter
• Atrial Premature Complexes
• Extrasystole, Atrial
• Premature Atrial Complex
• Premature Birth
• Premature Supraventricular Beats
• Supraventricular Beat, Premature

Intervention

Diagnostic Test:
• Holter recording
Holter recording with Zenicor Flex ECG during 14 days.
• Echocardiography (Echo)
Echocardiography: Comprehensive transthoracic echocardiography with special focus on atrial dimension and function.
• 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.
• 24 hour ambulatory blood pressure monitoring And Arteriograph
To assess artery stiffness.

Locations

Country	Name	City	State
Sweden	Danderyd Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Danderyd Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10-14 days
Secondary	the clinical development of atrial fibrillation subtype in patients diagnosed with atrial fibrillation.	Presence of paroxysmal or permanent atrial fibrillation on follow-up.	2 years
Secondary	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.	2 years
Secondary	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:	2 years
Secondary	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.	2 years
Secondary	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.	4 years or longer
Secondary	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.	2 years
Secondary	Artrial stiffness in relation to ESVEA and/or AF.	Comparison of artrial stiffness and blood pressure	2 yeras