Clinical trial NCT04593498: Excessive Supraventricular Activity and Atrial Fibrillation
Official title: Detection of Atrial Fibrillation in Patients With Excessive Supraventricular Activity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Atrial Flutter
Supraventricular Beat, Premature
Premature Supraventricular Beats
Premature Atrial Complex
Extrasystole, Atrial
Keywords: Excessive supraventricular ectopic activity
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Danderyd Hospital
First posted: 2020-10-20
Enrollment: 250
Sex: ALL
Minimum age (years): 70
Maximum age (years): 89
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals who have underwent Holter recording at Danderyd hospital after 2022.

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: atrial fibrillation yield in extended ECG screening among patients with ESVEA on Holter recording as compared to patients without ESVEA.
timeFrame: 10-14 days
Secondary outcomes:
measure: the clinical development of atrial fibrillation subtype in patients diagnosed with atrial fibrillation.
timeFrame: 2 years
measure: Temporal development of ESVEA and atrial cardiomyopathy on repeated Holter recordings.
timeFrame: 2 years
measure: Temporal development of several blood biomarkers with a possible relation to atrial cardiomyopathy in patients with and without ESVEA.
timeFrame: 2 years
measure: association between plasma biomarkers and the development of atrial fibrillation in patients with ESVEA.
timeFrame: 2 years
measure: Association between ESVEA, atrial fibrillation and other relevant comorbidities such as stroke, heart failure and major bleeding as well as mortality.
timeFrame: 4 years or longer
measure: echocardiographic parameters in relation to ESVEA and/or AF.
timeFrame: 2 years
measure: Artrial stiffness in relation to ESVEA and/or AF.
timeFrame: 2 yeras
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Danderyd Hospital
Study officials:
References: