Excessive Supraventricular Activity and Atrial Fibrillation

NCT04593498 | Recruiting

• 1 other identifier: ESA_AF2018
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Atrial Flutter; Supraventricular Beat, Premature; Premature Supraventricular Beats; Premature Atrial Complex; Extrasystole, Atrial

Keywords

Excessive supraventricular ectopic activity

Outcome Measures

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.

  10-14 days

Secondary Outcomes (7)

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

  2 years

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

  2 years

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

  2 years

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

  2 years

• Association between ESVEA, atrial fibrillation and other relevant comorbidities such as stroke, heart failure and major bleeding as well as mortality.

  4 years or longer

Study Arms (2)

ESVEA

ESVEA (Excessive supraventricular ectopic activity): Participants with at least 30 supraventricular extra systole (SVES)/h or a supraventricular run of at least 20 beats.

Diagnostic Test: Holter recording; Diagnostic Test: Echocardiography (Echo); Diagnostic Test: Blood sample; Diagnostic Test: 24 hour ambulatory blood pressure monitoring And Arteriograph

Non-ESVEA

Participants not meeting inclusion criteria

Diagnostic Test: Holter recording; Diagnostic Test: Echocardiography (Echo); Diagnostic Test: Blood sample; Diagnostic Test: 24 hour ambulatory blood pressure monitoring And Arteriograph

Interventions

Holter recording DIAGNOSTIC_TEST

Holter recording with Zenicor Flex ECG during 14 days.

ESVEA; Non-ESVEA

Echocardiography (Echo) DIAGNOSTIC_TEST

Echocardiography: Comprehensive transthoracic echocardiography with special focus on atrial dimension and function.

ESVEA; Non-ESVEA

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.

ESVEA; Non-ESVEA

24 hour ambulatory blood pressure monitoring And Arteriograph DIAGNOSTIC_TEST

To assess artery stiffness.

ESVEA; Non-ESVEA

Eligibility Criteria

• Age: 70 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Patients with at least 30 supraventricular extra systole (SVES)/h or a supraventricular run of at least 20 beats on a Holter recording.

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Danderyd Hospital: collaborator

Study Sites (1)

Danderyd Hospital

Stockholm, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

20 ml of plasma will be sampled at index and at 21 months in ESVEA and control group.

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter; Atrial Premature Complexes

Interventions

Echocardiography; Caves; Blood Specimen Collection; Blood Pressure Monitoring, Ambulatory

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Complexes, Premature; Cardiac Conduction System Disease

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Geological Phenomena; Physical Phenomena; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Investigative Techniques; Blood Pressure Determination; Monitoring, Ambulatory; Monitoring, Physiologic

Central Study Contacts

Johan Engdahl

CONTACT

0046812358242; johan.engdahl@regionstockholm.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Associate Professor

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 20, 2020
• Study Start: November 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 15, 2028
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)