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A Study to Investigate if Early Atrial Fibrillation (AF) Diagnosis Reduces Risk of Events Like Stroke in the Real-World

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04276441
Recruitment Status : Recruiting
First Posted : February 19, 2020
Last Update Posted : March 25, 2020
Sponsor:
Collaborator:
Apple Inc.
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC

Brief Summary:
The primary objectives of this study are to identify and diagnose Atrial Fibrillation (AF), evaluate improvement in cardiovascular (CV) outcomes, improve direct oral anti-coagulant (DOAC) adherence and persistence, and better characterize participants and identify predictors of disease.

Condition or disease Intervention/treatment
Atrial Fibrillation Device: Heart healthy Engagement Program with the Apple Watch Series 4 or later Device: Anti-Coagulation Adherence Module with the Apple Watch Series 5 or later

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Study Type : Observational
Estimated Enrollment : 150000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: HEARTLINE - A Heart Health Study Using Digital Technology to Investigate if Early AF Diagnosis Reduces the Risk of Thromboembolic Events Like Stroke IN the Real-world Environment
Actual Study Start Date : February 25, 2020
Estimated Primary Completion Date : December 29, 2023
Estimated Study Completion Date : December 29, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Non- Atrial Fibrillation (AF) Cohort
Participants without a history of AF will be randomly assigned into the study to either an Apple Watch/iPhone group or an iPhone group only.
Device: Heart healthy Engagement Program with the Apple Watch Series 4 or later
No drug will be given as part of this study. Participants without a diagnosis of AF will be enrolled and a heart healthy Engagement Program delivered via the Heartline app on the iPhone with the Apple Watch Series 5 or later.

Atrial Fibrillation (AF) Cohort
Participants with a diagnosis of AF taking a direct oral anti-coagulant (DOAC) for at least 30 days will be randomly assigned to Apple Watch/iPhone group or iPhone group only.
Device: Anti-Coagulation Adherence Module with the Apple Watch Series 5 or later
No drug will be given as part of this study. Participants with a diagnosis of AF (taking a DOAC for at least 30 days) will be enrolled and an Anti Coagulation Adherence Module delivered via the Heartline app on the iPhone with an Apple Watch Series 5 or later.




Primary Outcome Measures :
  1. Time from Randomization to Clinically Confirmed Diagnosis of Atrial Fibrillation (AF) [ Time Frame: Up to 3 years ]
    Time to a clinically confirmed diagnosis of AF with validation from claims data.

  2. Percent Days Covered (PDC) by Direct Oral Anti-Coagulant (DOAC) Prescription Fills [ Time Frame: Up to 3 years ]
    Percent days of covered prescription DOAC use minus any evidence of no prescription use/refills over the time interval chosen.


Secondary Outcome Measures :
  1. Time to Composite of 2-Point Major Adverse Cardiovascular Events (MACE) (CVA or ACM) [ Time Frame: Up to 3 years ]
    Composite clinical endpoint includes all cause mortality (ACM) and cerebrovascular accident (CVA).

  2. Total Cost of Care Delivery [ Time Frame: Up to 3 years ]
    Total costs of care reported as number of health resource utilization events times the unit cost for each event.

  3. Total Health Resource Utilization [ Time Frame: Up to 3 years ]
    Health resource utilization (HRU) reported as counts of HRU events.

  4. Total Cost Effectiveness [ Time Frame: Up to 3 years ]
    Cost effectiveness to be assessed by including the cost to diagnosis, treatment and reported clinical outcome.

  5. Time to Composite of 3-Point MACE (CVA, MI, or ACM) [ Time Frame: Up to 3 years ]
    A composite 3-point MACE clinical endpoint includes ACM, myocardial infarction (MI) and CVA.

  6. Time to Composite of 4-Point MACE (CVA, MI, non-CNS embolism or thrombosis, or ACM) [ Time Frame: Up to 3 years ]
    A composite 4-point MACE clinical endpoint includes ACM, MI, non-CNS embolism or thrombosis and CVA.

  7. Time to Cerebrovascular Accident [ Time Frame: Up to 3 years ]
    Cerebrovascular accident (CVA) is defined by ischemic CVA.

  8. Time to Myocardial Infarction [ Time Frame: Up to 3 years ]
    Myocardial infarction (MI) is defined as a hospitalization/diagnosis for MI.

  9. Time to non-Central Nervous System (CNS) Embolism or Thrombosis [ Time Frame: Up to 3 years ]
    Non-CNS embolism or thrombosis is defined as hospitalization for non-CNS thromboembolic events.

  10. Time to all-Cause Mortality [ Time Frame: Up to 3 years ]
    All cause mortality (ACM) is defined as deaths from all (reported) causes.

  11. Time to Hospitalization or Emergency Department (ED) Visit for Atrial Fibrillation or Heart Failure [ Time Frame: Up to 3 years ]
    Hospitalization or ED visit for Atrial Fibrillation (AF) or Heart Failure (HF) is defined as an in-patient stay or an outpatient ED visit for AF or HF.

  12. Time to Hospitalization for Bleeding [ Time Frame: Up to 3 years ]
    Hospitalization for bleeding is defined as in-patient stay for a bleeding event.

  13. Time to Hospitalization for Hemorrhagic cerebrovascular accident (CVA) [ Time Frame: Up to 3 years ]
    Hospitalization for hemorrhagic CVA is defined as an in-patient stay for a hemorrhagic CVA.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The study population includes an older age group in whom the risk of developing Atrial Fibrillation (AF) is increased and who may benefit from a broad, health-focused Engagement Program paired with the irregular rhythm notification (IRN) alert (photoplethysmogram [PPG] sensor based) and electrocardiogram (ECG) sensor of the Apple Watch Series 5 or later.
Criteria
  • Medicare beneficiary with Traditional or Original Medicare coverage
  • Medicare beneficiary with Medicare Advantage (waitlisted)
  • Authorize electronic access to their healthcare claims data
  • Authorize sharing of device sensor, health, and Heartline app data from their iPhone and Apple Watch (if applicable). This includes Apple Watch and iPhone sensor data that is not publicly available
  • Willing and able to provide informed consent by electronically signing the remote e-consent directly in the Heartline app prior to any study-related activities. Electronically signing the remote e-consent indicates that he/she understands the purpose of, and activities required for the study and is willing to participate for the 2-year Active Engagement Phase, with continued passive collection of their device and healthcare claims data for an additional 1 year in the Post-Engagement Follow-Up Phase
  • Current resident of the US at the time of eligibility screening, defined by self-reported state of residence within the 50 states or the US or District of Columbia
  • Own an iPhone 6s or later with iOS Version 12.2 or later

Exclusion Criteria:

  • Limited life expectancy and/or current diagnosis of terminal cancer
  • Unable to confirm meeting inclusion criteria, including ability to consent and participate in human participant's research
  • Own an Apple Watch Series 0 paired with an iPhone at the time of screening eligibility (these participants are not eligible for any study cohorts [randomized or observational])
  • Have a confirmed diagnosis of Atrial Fibrillation (AF) at study entry and currently taking a direct oral anti-coagulant (DOAC) for less then (<) 30 days, currently taking other anti-coagulant medication(s) for AF other than a DOAC, or currently not taking medication for AF

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): NCT04276441


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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United States, California
Evidation Health Recruiting
San Mateo, California, United States, 94401
Sponsors and Collaborators
Janssen Scientific Affairs, LLC
Apple Inc.
Investigators
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Study Director: Janssen Scientific Affairs, LLC Clinical Trial Janssen Scientific Affairs, LLC
Additional Information:
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Responsible Party: Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT04276441    
Other Study ID Numbers: CR108633
NOPRODAFL0002 ( Other Identifier: Janssen Scientific Affairs, LLC )
First Posted: February 19, 2020    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes