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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT04404465
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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 Dates

Start date
Sep 15, 2020
Status verified
Jul 2025
Primary completion
Sep 15, 2030
Completion
Sep 15, 2040

Study Design

Enrollment
3,000 participants (estimated)

Arms

  • Arm: 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
  • Arm: 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.)
  • Arm: 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 Measure

Incident AF [At Risk Group] [ Time Frame: 10 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143-

Find similar trials in San Francisco, CA

By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
University of California, San Francisco· San Francisco, CA

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