Health eHeart BEAT-AFib - Health eHeart Biomarkers of Early Atrial Transformation in Atrial Fibrillation
NCT ID: NCT04404465
Last Updated: 2025-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
3000 participants
OBSERVATIONAL
2020-09-15
2040-09-15
Brief Summary
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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.
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Detailed Description
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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)
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
No interventions assigned to this 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.)
No interventions assigned to this group
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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. English speaking
3. Able to consent
4. ANY one of the following criteria:
1. Patients undergoing ablation for AF.
2. 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).
3. A history of newly diagnosed persistent AF with documented normal sinus rhythm within 6 months of enrollment and undergoing cardioversion fot AF.
4. 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
5. More than 5% PAC burden on ambulatory ECG monitoring (e.g. Holter, Ziopatch, Lifewatch, etc.)
6. Patients undergoing EP study or ablation for SVT with no history of AF and not meeting any of the above criteria (a-c).
Exclusion Criteria
2. Reversible causes of AF (e.g., post-operative AF, cardiac surgery, pulmonary embolism, untreated hyperthyroidism)
3. Pregnant at the time of enrollment
4. Unwilling/unable to perform follow-up using digital follow-up
5. CKD requiring dialysis
6. 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
7. Patients undergoing active treatment for cancer or diagnosed with cancer requiring treatment in the last 2 years
8. Severe Valvular Disease (eg. Rheumatic Heart Disease, Severe Mitral Valve Regurgitation, severe tricuspid regurgitation, severe aortic stenosis, or valve replacements)
9. History of organ transplant
10. History of any significant congenital heart defect
11. Existing Pacemakers and ICDs if not undergoing an ablation
18 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Jeffrey E Olgin, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Edward P Gerstenfeld, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Mark J Pletcher, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Gregory Marcus, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Atrial Fibrillation fact sheet from the Centers for Disease Control and Prevention website.
Other Identifiers
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BEAT-AFib
Identifier Type: -
Identifier Source: org_study_id
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