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

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04276441
• Other study ID #: CR108633
• Secondary ID: NOPRODAFL0002
• Status: Active, not recruiting
• Start date: February 25, 2020
• Est. completion date: December 28, 2025

Study information

• Verified date: June 2024
• Source: Janssen Scientific Affairs, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 34244
• Est. completion date: December 28, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Medicare beneficiary either with Original or Medicare advantage

• 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 than (<) 30 days, currently taking other anti-coagulant medication(s) for AF other than a DOAC, or currently not taking medication for AF

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Heart healthy Engagement Program with the Apple Watch Series 5 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.
• 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.

Locations

Country	Name	City	State
United States	Evidation Health	San Mateo	California

Sponsors (2)

Lead Sponsor	Collaborator
Janssen Scientific Affairs, LLC	Apple Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from Randomization to Clinical Diagnosis of Atrial Fibrillation (AF)	Time to a clinical diagnosis of AF obtained from healthcare claims database.	Up to 3 years
Primary	Percent Days Covered (PDC) by Direct Oral Anti-Coagulant (DOAC) Prescription Fills	Percent days of covered prescription DOAC use minus any evidence of no prescription use/refills over the time interval chosen.	Up to 3 years
Secondary	Time to Composite of 6-component Events (Ischemic Stroke/TIA, MI, Non-CNS Embolism or Thrombosis, Hospitalization or ED Visit for HF, CV Hospitalization and ACM)	Time to composite of 6-component events (ischemic stroke/transient ischemic attack [TIA], myocardial infarction [MI], non-central nervous system [CNS] embolism or thrombosis, hospitalization or emergency department [ED] visit due to heart failure [HF], cardiovascular [CV] hospitalization, and all-cause mortality [ACM]), obtained from randomization in the healthcare claims database, will be reported.	Up to 3 years
Secondary	Summary of Total Cost of Care Delivery, Total Health Resource Utilization (HRU), and Cost Effectiveness	Summary of total cost of care delivery, total HRU, and cost effectiveness will be reported. Total costs of care reported as number of HRU events times the unit cost for each event. HRU reported as counts of HRU events. Cost effectiveness to be assessed by including the cost to diagnosis, treatment and reported clinical outcome.	Up to 3 years
Secondary	Time to Ischemic stroke/TIA	Ischemic stroke/TIA is defined as a hospitalization/diagnosis for Ischemic stroke/TIA.	Up to 3 years
Secondary	Time to MI	MI is defined as a hospitalization/diagnosis for MI.	Up to 3 years
Secondary	Time to non-CNS Embolism or Thrombosis	Non-CNS embolism or thrombosis is defined as hospitalization for non-CNS thromboembolic events.	Up to 3 years
Secondary	Time to Hospitalization or ED for HF	Hospitalization or ED visit for HF is defined as an in-patient stay or an outpatient ED visit for HF.	Up to 3 years
Secondary	Time to CV Hospitalization	Hospitalization for CV is defined as an in-patient stay for CV disease.	Up to 3 years
Secondary	Time to all-Cause Mortality	All-cause mortality (ACM) is defined as deaths from all (reported) causes.	Up to 3 years
Secondary	Time to Composite Bleeding Events Resulting in Hospitalization	Hospitalization for composite bleeding events (such as intracranial hemorrhage, gastrointestinal [GI], respiratory, intraocular) is defined as in-patient stay for bleeding events, as reported in the healthcare claims database.	Up to 3 years
Secondary	Time to Hospitalization for Hemorrhagic Stroke	Hospitalization for hemorrhagic stroke is defined as an in-patient stay for a hemorrhagic stroke.	Up to 3 years

External Links

•   Study website