NEW BRUNSWICK, N.J.,
Feb. 25, 2020 /PRNewswire/
-- Johnson & Johnson (NYSE: JNJ) today announced that the
Janssen Pharmaceutical Companies of Johnson & Johnson, in
collaboration with Apple, opened enrollment for the Heartline
Study. The study is designed to explore if the Heartline Study app
on iPhone and heart health features on Apple Watch can improve
health outcomes, including reducing the risk of stroke, with
earlier detection of atrial fibrillation (AFib). AFib, a common
form of irregular heart rhythm, is a leading cause of stroke in the
U.S. To enroll in the Heartline Study, individuals must be age 65
or older, a U.S. resident, have Original (traditional) Medicare,
own an iPhone 6s or a later model, and agree to provide access to
their Medicare claims data. To learn more, determine
eligibility to participate, and download the app, visit
Heartline.com.
Experience the interactive Multichannel News Release here:
https://www.multivu.com/players/English/8693251-heartline-study/
"Heartline is a study that has the potential to
fundamentally change our understanding of how digital health
tools, like the ECG app and irregular rhythm notification feature
on Apple Watch, could lead to earlier detection of AFib,
helping patients understand and directly engage in their heart
health, prompting potentially life-saving conversations with their
doctors, and improving health outcomes," notes
Dr. C. Michael Gibson*, Co-Chair of the Heartline
Executive Committee and Professor of Medicine, Harvard Medical School and CEO, Baim Institute.
CLICK TO TWEET: "The Heartline Study from #JNJ, in
collaboration with #Apple, has the potential to fundamentally
change our understanding of how technology can help improve health
outcomes," says Heartline™ Executive Committee Co-Chair
@CMichaelGibson
Despite the fact that AFib is a leading cause of stroke, people
often do not experience symptoms, making it difficult to diagnose.
More than 33 million people worldwide and up to six million
Americans live with AFib.1,2 Up to 30% don't even
know they have it until a serious cardiovascular event, such as a
stroke, occurs.3 According to the U.S. Centers for
Disease Control and Prevention, AFib, the most common sustained
cardiac arrhythmia, results in 158,000 deaths and 454,000
hospitalizations each year.2
"As we look to tackle some of the greatest health care
challenges, we must bring the best minds and capabilities to the
table," said Paul Burton, M.D.,
Ph.D., FACC, Vice President, Medical Affairs, Internal
Medicine, Janssen Scientific Affairs, LLC, a Janssen Pharmaceutical
Company of Johnson & Johnson. "Through this important
collaboration with Apple, we are pioneering new models that we hope
can break down some of the most common barriers to participation in
clinical studies. Our work continues to develop and deliver
solutions for those impacted by AFib in the areas of detection,
treatment and care, through novel approaches, so that we can
potentially improve their lives today and well into the
future."
One of the key objectives of this nationwide, randomized study
is to assess if a heart health engagement program provided through
the Heartline Study app on iPhone, in combination with the ECG app
and the irregular rhythm notification feature on Apple Watch, can
reduce the likelihood of stroke and improve health outcomes with
the earlier detection of AFib.
- The engagement program, via the Heartline Study app from
Johnson & Johnson, will provide ongoing education, tips,
surveys and questionnaires across many topics related to overall
heart health throughout the two-year active engagement period.
- The ECG app can classify an electrocardiogram as sinus rhythm
or AFib.
- The irregular rhythm notification feature will provide
notifications of irregular heart rhythms suggestive of AFib.
Through the app-based approach, the study will enable
participants to engage in the study remotely, right from their
iPhone and in some cases an Apple Watch, rather than travel to a
clinical trial site. This approach to conducting a clinical
trial, if successful, could potentially save time and cost.
"Apple technology is making a meaningful impact on scientific
research through the powerful capabilities of iPhone and Apple
Watch, all with privacy at the center of the participant
experience," said Myoung Cha, Apple's Head of Health
Strategic Initiatives. "The Heartline Study will help further
understanding of how our technology could both contribute to
science and help improve health outcomes, including reducing the
risk of stroke."
About the Heartline Study
The Heartline Study is a nationwide, randomized, controlled,
app-based, virtual research study sponsored by Janssen
Pharmaceuticals, Inc., a member of the Janssen Pharmaceutical
Companies of Johnson & Johnson. The team worked
with Apple to jointly design the research study and the Heartline
Study app. The study brings together Johnson & Johnson's health
expertise with Apple's expertise in design, technology and privacy.
Evidation Health, a collaborator in the study, provides the
technology and study operations that enable the Heartline Study app
and study experience for participants.
To be eligible for the study, participants must be age 65 or
older, a resident of the United
States for the duration of the study, have Original
(traditional) Medicare, have an iPhone 6s or a later model (with
iOS version 12.2 or later), and agree to provide access to
their Medicare claims data. Additional entry criteria may apply.
Eligible participants will be randomized to one of two possible
groups. One group will participate by only using the Heartline
Study app on their iPhone. The other group will participate by
using the study app on their iPhone in addition to obtaining an
Apple Watch to use the ECG app and irregular rhythm notification
feature. Participants who already own an Apple Watch may be
eligible to join the study as well, with certain restrictions.
Participation in the study will span a total of three years with
two years of active engagement, followed by one year of additional
data collection. During the active engagement period, participants
will receive heart health education, wellness tips, surveys, and
questionnaires across multiple topics related to overall heart
health in the app each week.
About Johnson & Johnson
At Johnson & Johnson, we believe good health is the foundation
of vibrant lives, thriving communities and forward progress. That's
why for more than 130 years, we have aimed to keep people well at
every age and every stage of life. Today, as the world's largest
and most broadly-based health care company, we are committed to
using our reach and size for good. We strive to improve access and
affordability, create healthier communities, and put a healthy
mind, body and environment within reach of everyone, everywhere. We
are blending our heart, science and ingenuity to profoundly change
the trajectory of health for humanity.
About the Janssen Pharmaceutical Companies of Johnson &
Johnson
At Janssen, we're creating a future where disease is a thing of the
past. We're the Pharmaceutical Companies of Johnson & Johnson,
working tirelessly to make that future a reality for patients
everywhere by fighting sickness with science, improving access with
ingenuity, and healing hopelessness with heart. We focus on areas
of medicine where we can make the biggest difference:
Cardiovascular & Metabolism, Immunology, Infectious Diseases
& Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
Follow us @JanssenGlobal. Janssen Pharmaceuticals, Inc. and Janssen
Scientific Affairs, LLC are both part of the Janssen Pharmaceutical
Companies of Johnson & Johnson.
Cautions Concerning Forward-Looking Statements
This
press release contains "forward-looking statements" as defined in
the Private Securities Litigation Reform Act of 1995 regarding the
Heartline™ Study. The reader is cautioned not to rely
on these forward-looking statements. These statements are based on
current expectations of future events. If underlying assumptions
prove inaccurate or known or unknown risks or uncertainties
materialize, actual results could vary materially from the
expectations and projections of Janssen Pharmaceuticals, Inc., any
of the other Janssen Pharmaceutical Companies and/or Johnson &
Johnson. Risks and uncertainties include, but are not limited to:
challenges and uncertainties inherent in product research and
development, including the uncertainty of clinical success and of
obtaining regulatory approvals; uncertainty of commercial success;
competition, including technological advances, new products and
patents attained by competitors; challenges to patents; changes in
behavior and spending patterns of purchasers of health care
products and services; changes to applicable laws and regulations,
including global health care reforms; and trends toward health care
cost containment. A further list and descriptions of these risks,
uncertainties and other factors can be found in Johnson &
Johnson's Annual Report on Form 10-K for the fiscal year ended
December 29, 2019, including in the
sections captioned "Cautionary Note Regarding Forward-Looking
Statements" and "Item 1A. Risk Factors," and in the company's most
recently filed Quarterly Report on Form 10-Q, and the company's
subsequent filings with the Securities and Exchange Commission.
Copies of these filings are available online at www.sec.gov,
www.jnj.com or on request from Johnson & Johnson. None of
the Janssen Pharmaceutical Companies nor Johnson & Johnson
undertakes to update any forward-looking statement as a result of
new information or future events or developments.
1 Morillo CA, Banerjee A, Perel P, Wood D,
Jouven X. Atrial fibrillation: the current epidemic. J
Geriatr Cardiol. 2017;14(3):195–203.
doi:10.11909/j.issn.1671-5411.2017.03.011
2 https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_atrial_fibrillation.htm
3 Reiffel JA, Verma A, Kowey PR, et al.
Incidence of Previously Undiagnosed Atrial Fibrillation Using
Insertable Cardiac Monitors in a High-Risk Population: The
REVEAL AF Study. JAMA
Cardiol. 2017;2(10):1120–1127.
doi:10.1001/jamacardio.2017.3180.
MEDIA CONTACT:
Kristina
Chang
+1 (201) 213-4115
Kchang12@its.jnj.com
INVESTOR RELATIONS CONTACT:
Lesley Fishman
+1 (732) 524-3922
LFishma@its.jnj.com
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SOURCE Johnson & Johnson