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

Enrolling by invitation

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT04404465

Run by

University of California, San Francisco

People needed

3000

Starts

2020-09-15

Expected to finish

2040-09-15

Last updated by the study team

2026-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years of age or older
• English speaking
• Able to consent
• ANY one of the following criteria:
• Patients undergoing ablation for AF.
• A history of non-valvular AF or AFL (not due to a reversible cause) documented on ECG or ambulatory monitoring within 1 year of enrollment and not on chronic anti-arrhythmic drugs (AAD).
• A history of newly diagnosed persistent AF with documented normal sinus rhythm within 6 months of enrollment and undergoing cardioversion fot AF.
• Two or more of the following criteria if no history of AF:
• Age > 65 years of age
• A diagnosis of hypertension
• A diagnosis of diabetes
• A diagnosis of sleep apnea
• A BMI ≥ 30
• Stable HF with preserved or reduced ejection fraction (NYHA Class I, II or III)
• CKD not requiring dialysis
• More than 5% PAC burden on ambulatory ECG monitoring (e.g. Holter, Ziopatch, Lifewatch, etc.)
• Patients undergoing EP study or ablation for SVT with no history of AF and not meeting any of the above criteria (a-c).

You may not qualify if…

• Life expectancy < 1 year
• Reversible causes of AF (e.g., post-operative AF, cardiac surgery, pulmonary embolism, untreated hyperthyroidism)
• Pregnant at the time of enrollment
• Unwilling/unable to perform follow-up using digital follow-up
• CKD requiring dialysis
• Presence of a condition or abnormality that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data
• Patients undergoing active treatment for cancer or diagnosed with cancer requiring treatment in the last 2 years
• Severe Valvular Disease (eg. Rheumatic Heart Disease, Severe Mitral Valve Regurgitation, severe tricuspid regurgitation, severe aortic stenosis, or valve replacements)
• History of organ transplant
• History of any significant congenital heart defect
• Existing Pacemakers and ICDs if not undergoing an ablation

Where it is running

• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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