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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04404465
Recruitment Status : Enrolling by invitation
First Posted : May 27, 2020
Last Update Posted : April 7, 2022
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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
Atrial Fibrillation

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)

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Study Type : Observational
Estimated 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 : September 15, 2020
Estimated Primary Completion Date : September 15, 2030
Estimated Study Completion Date : September 15, 2040

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. Incident AF [At Risk Group] [ Time Frame: 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] [ Time Frame: 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] [ Time Frame: 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] [ Time Frame: 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.


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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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:

    1. A history of non-valvular AF or AFL documented on ECG or ambulatory monitoring within 1 year of enrollment
    2. 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
    3. More than 5% PAC burden on ambulatory ECG monitoring (e.g. Holter, Ziopatch, Lifewatch, etc.)
    4. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04404465


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
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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
Additional Information:
Publications:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04404465    
Other Study ID Numbers: BEAT-AFib
First Posted: May 27, 2020    Key Record Dates
Last Update Posted: April 7, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes