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

Sponsor
University of California, San Francisco (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04404465
Collaborator
(none)
3,000
Enrollment
1
Location
240
Anticipated Duration (Months)
12.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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)

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    3000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Health eHeart BEAT-AFib - Health eHeart Biomarkers of Early Atrial Transformation in Atrial Fibrillation
    Actual Study Start Date :
    Sep 15, 2020
    Anticipated Primary Completion Date :
    Sep 15, 2030
    Anticipated Study Completion Date :
    Sep 15, 2040

    Arms and Interventions

    Arm Intervention/Treatment
    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: 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 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

    Outcome Measures

    Primary Outcome Measures

    1. Incident AF [At Risk Group] [10 years]

      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.

    2. Progression of AF [AF Group] [10 years]

      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.

    Secondary Outcome Measures

    1. Recurrence of AF after treatment with direct current cardioversion (DCCV) or AF ablation [AF Group] [10 years]

      Recurrence of AF will be evaluated 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.

    2. Symptom Burden [AF Group] [10 years]

      Symptom Burden will be scored by use of the University of Toronto Atrial Fibrillation Symptom Severity Scale (AFSS) which includes seven questions for subjects to report severity of symptoms (i.e. palpitations, chest pain/discomfort, shortness of breath at rest/physical activity, exercise intolerance, fatigue at rest, and lightheadedness/dizziness) on a Likert scale from 0 (subject did not have this symptom) to 5 (symptom bothers subject a great deal). Total Symptom Burden score is a sum of these seven questions and can range from 0 to 35 with a higher score indicating greater burden.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. At least 18 years of age or older

    2. English speaking

    3. Able to consent

    4. ANY one of the following criteria:

    5. A history of non-valvular AF or AFL documented on ECG or ambulatory monitoring within 1 year of enrollment

    6. 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

    1. More than 5% PAC burden on ambulatory ECG monitoring (e.g. Holter, Ziopatch, Lifewatch, etc.)

    2. 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:

    1. Life expectancy < 1 year

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California, San Francisco San Francisco California United States 94143

    Sponsors and Collaborators

    • University of California, San Francisco

    Investigators

    • Principal Investigator: 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT04404465
    Other Study ID Numbers:
    • BEAT-AFib
    First Posted:
    May 27, 2020
    Last Update Posted:
    Apr 7, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Atrial Fibrillation

    Study Results

    No Results Posted as of Apr 7, 2022