Health eHeart BEAT-AFib - Health eHeart Biomarkers of Early Atrial Transformation in Atrial Fibrillation — BEAT-AFib  

Atrial Fibrillation Clinical Trial

Official title: Health eHeart BEAT-AFib - Health eHeart Biomarkers of Early Atrial Transformation in Atrial Fibrillation

Status Enrolling by invitation

Clinical Trial Summary

Atrial fibrillation (also known as AFib or AF) is the most common abnormal heart rhythm and results in an irregular beating of the heart. Currently, there is no way of identifying patients at most risk for the development or progression of AFib or those that will best respond to treatment. The purpose of this study is to improve our understanding of AFib and to find new ways of identifying those patients most at risk for developing AFib, have progressive AFib or be less responsive to treatment. For this reason, the investigators are studying imaging, blood, and digital markers that may contribute to AFib

Subjects will receive mobile devices (uch as an AliveCor Kardia and a VivaLnk Wearable ECG patch or similar devices) for remote electrocardiographic (ECG) monitoring. Additionally, subjects will use features using a smartphone research app (on the Eureka Research Platform) to monitor other important things such as activity, sleep, heart rate and others as they are developed. All subjects will receive serial blood draws and saliva sample collections once a year. Subjects will also undergo annual imaging in the form of an echocardiogram (Echo). Evaluations will be taken at baseline and once a year for three years from the baseline visit. Additionally, electronic surveys will be administered periodically (eVisits occurring every 3-6 months) using the mobile app.

Clinical Trial Description

This is a single center, longitudinal, observational cohort study. 3000 subjects are planned to be enrolled. Each subject will be consented, enrolled and assigned to a group based on AF diagnosis (AF Group, AF Risk Group and Control Group). All subjects will be given mobile devices (such as an AliveCor Kardia and a VivaLnk Wearable ECG patch or similar devices) for remote ECG monitoring. Additionally, sleep and activity can be monitored through a smartphone app (on the Eureka Research Platform). All subjects will receive serial blood draws and saliva sample collections to collect serum, plasma, whole blood, DNA and RNA in order to observe/identify any changes in blood-borne AF markers. Subjects will also undergo serial imaging in the form of an Echo to observe/identify markers and/or changes in cardiovascular structure and functioning. Evaluations will be taken at baseline and once a year for three years from their baseline visit. Additionally, electronic surveys will be administered periodically (eVisits occurring every 3-6 months) using the mobile app to observe any changes in participant reported symptoms.

Any participant who receives an AF ablation as part of clinical care will additionally receive one in-person follow-up three months post-ablation procedure and an electronic survey one month post-ablation procedure to observe changes in symptoms after ablation.

Subjects will be followed for at least 3 years. The total duration of the study is expected to be at least 10 years. It is expected that it will take 3-4 years for subject recruitment and at least 3 years for subject follow-up (3 yearly in-person visits), but anticipate the digital follow-up to go beyond that (at least 10 years of digital follow-up) ;

Related Conditions & MeSH terms

• Atrial Fibrillation

• NCT number: NCT04404465
• Study type: Observational
• Source: University of California, San Francisco
• Status: Enrolling by invitation
• Start date: September 15, 2020
• Completion date: September 15, 2040