Atrial Fibrillation Clinical Trial
— ESA-AFOfficial 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.
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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Danderyd Hospital | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | Danderyd Hospital |
Sweden,
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 |
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