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

NCT04404465 | Enrolling By Invitation

• 1 other identifier: BEAT-AFib
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Incident AF [At Risk Group]

  Incident AF is defined as the development of a new onset AF in subjects who do not have a previous AF diagnosis. This will be evaluated by detection of arrhythmias by use of ambulatory ECG monitoring (using an VivaLnk Wearable ECG patch and an AliveCor Kardia) and will be diagnosed by an automated algorithm that detects irregularly irregular rhythms. A random 50% of events will be overread by a cardiologist.

  10 years

• Progression of AF [AF Group]

  Progression of AF is defined as increase in AF burden which is the amount of time spent in AF over the course of one month as determined by use of ambulatory ECG monitoring (using an VivaLnk Wearable ECG patch and an AliveCor Kardia) and will be diagnosed by an automated algorithm that detects irregularly irregular rhythms. A random 50% of events will be overread by a cardiologist.

  10 years

Secondary Outcomes (2)

• Recurrence of AF after treatment with direct current cardioversion (DCCV) or AF ablation [AF Group]

  10 years

• Symptom Burden [AF Group]

  10 years

Study Arms (3)

Control Group

Participants undergoing electrophysiologic (EP) study or ablation for supraventricular tachycardia (SVT) with no history of AF and does not meet criteria of At Risk Group or AF Group

At Risk Group

Participants with no prior diagnosis of AF and have: 1. two or more of the following criteria: * Age \>65 years of age * A diagnosis of hypertension * A diagnosis of diabetes * A diagnosis of sleep apnea * A body mass index (BMI) ≥30 * Stable heart failure (HF) with preserved or reduced ejection fraction (New York Heart Association Class I, II or III) * Chronic kidney disease (CKD) not requiring dialysis AND/ OR 2. More than 5% premature atrial complex (PAC) burden on ambulatory ECG monitoring (e.g. holter, ZioPatch, Lifewatch, etc.)

AF Group

Participants who have a history of non-valvular AF or Atrial Flutter (AFL) documented on ECG or ambulatory monitoring within 1 year of enrollment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with a diagnosis of AF (i.e. new onset AF, paroxysmal AF, persistent AF, Permanent AF), those undergoing AF ablation or DCCV, those with a PAC greater or equal to 5% PAC burden, those undergoing SVT ablation, subjects with high risk of AF and healthy volunteers at least 18 years of age or older who have been seen at UCSF, who meet the inclusion and exclusion criteria will be eligible for participation in this study.

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

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (10)

• January CT, Wann LS, Calkins H, Chen LY, Cigarroa JE, Cleveland JC Jr, Ellinor PT, Ezekowitz MD, Field ME, Furie KL, Heidenreich PA, Murray KT, Shea JB, Tracy CM, Yancy CW. 2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2019 Jul 9;74(1):104-132. doi: 10.1016/j.jacc.2019.01.011. Epub 2019 Jan 28. No abstract available.

  PMID: 30703431 BACKGROUND

• Staerk L, Wang B, Preis SR, Larson MG, Lubitz SA, Ellinor PT, McManus DD, Ko D, Weng LC, Lunetta KL, Frost L, Benjamin EJ, Trinquart L. Lifetime risk of atrial fibrillation according to optimal, borderline, or elevated levels of risk factors: cohort study based on longitudinal data from the Framingham Heart Study. BMJ. 2018 Apr 26;361:k1453. doi: 10.1136/bmj.k1453.

  PMID: 29699974 BACKGROUND

• Sivalokanathan S, Zghaib T, Greenland GV, Vasquez N, Kudchadkar SM, Kontari E, Lu DY, Dolores-Cerna K, van der Geest RJ, Kamel IR, Olgin JE, Abraham TP, Nazarian S, Zimmerman SL, Abraham MR. Hypertrophic Cardiomyopathy Patients With Paroxysmal Atrial Fibrillation Have a High Burden of Left Atrial Fibrosis by Cardiac Magnetic Resonance Imaging. JACC Clin Electrophysiol. 2019 Mar;5(3):364-375. doi: 10.1016/j.jacep.2018.10.016. Epub 2018 Dec 26.

  PMID: 30898240 BACKGROUND

• Rahmutula D, Zhang H, Wilson EE, Olgin JE. Absence of natriuretic peptide clearance receptor attenuates TGF-beta1-induced selective atrial fibrosis and atrial fibrillation. Cardiovasc Res. 2019 Feb 1;115(2):357-372. doi: 10.1093/cvr/cvy224.

  PMID: 30239604 BACKGROUND

• Rahmutula D, Marcus GM, Wilson EE, Ding CH, Xiao Y, Paquet AC, Barbeau R, Barczak AJ, Erle DJ, Olgin JE. Molecular basis of selective atrial fibrosis due to overexpression of transforming growth factor-beta1. Cardiovasc Res. 2013 Sep 1;99(4):769-79. doi: 10.1093/cvr/cvt074. Epub 2013 Apr 23.

  PMID: 23612580 BACKGROUND

• Kim AM, Olgin JE. Microfibrosis and complex fractionated atrial electrograms. Heart Rhythm. 2009 Jun;6(6):811-2. doi: 10.1016/j.hrthm.2009.03.006. Epub 2009 Mar 3. No abstract available.

  PMID: 19467509 BACKGROUND

• Everett TH 4th, Olgin JE. Atrial fibrosis and the mechanisms of atrial fibrillation. Heart Rhythm. 2007 Mar;4(3 Suppl):S24-7. doi: 10.1016/j.hrthm.2006.12.040. Epub 2006 Dec 28.

  PMID: 17336879 BACKGROUND

• Marcus GM, Yang Y, Varosy PD, Ordovas K, Tseng ZH, Badhwar N, Lee BK, Lee RJ, Scheinman MM, Olgin JE. Regional left atrial voltage in patients with atrial fibrillation. Heart Rhythm. 2007 Feb;4(2):138-44. doi: 10.1016/j.hrthm.2006.10.017. Epub 2006 Oct 20.

  PMID: 17275746 BACKGROUND

• Lee KW, Everett TH 4th, Rahmutula D, Guerra JM, Wilson E, Ding C, Olgin JE. Pirfenidone prevents the development of a vulnerable substrate for atrial fibrillation in a canine model of heart failure. Circulation. 2006 Oct 17;114(16):1703-12. doi: 10.1161/CIRCULATIONAHA.106.624320. Epub 2006 Oct 9.

  PMID: 17030685 BACKGROUND

• Verheule S, Sato T, Everett T 4th, Engle SK, Otten D, Rubart-von der Lohe M, Nakajima HO, Nakajima H, Field LJ, Olgin JE. Increased vulnerability to atrial fibrillation in transgenic mice with selective atrial fibrosis caused by overexpression of TGF-beta1. Circ Res. 2004 Jun 11;94(11):1458-65. doi: 10.1161/01.RES.0000129579.59664.9d. Epub 2004 Apr 29.

  PMID: 15117823 BACKGROUND

Related Links

• Atrial Fibrillation fact sheet from the Centers for Disease Control and Prevention website.

Biospecimen

Retention: SAMPLES WITH DNA

During the in-person baseline visit and at each in-person follow-up visit all participants will have up to five (5) 10 mL tubes of peripheral blood specimens (approximately 50mL) collected by typical phlebotomy procedures by trained staff. Additionally, saliva may be collected with a DNA Spit Kit during the in-person baseline visit and at each in-person follow-up visit. Participants who receive AF ablation as part of routine clinical care will additionally have up to one (1) 10 mL tube of both Coronary Sinus and (1) 10 mL tube of Left Atrial blood specimens collected at time of procedure for approximately a total of 20 mL between both sources.

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeffrey E Olgin, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Edward P Gerstenfeld, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Mark J Pletcher, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Gregory Marcus, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 27, 2020
• Study Start: September 15, 2020
• Primary Completion (Estimated): September 15, 2030
• Study Completion (Estimated): September 15, 2040
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)