ABBOTT PARK, Ill., May 6, 2021
/PRNewswire/ -- Abbott (NYSE: ABT) today announced a new trial
focused on improving the treatment for people simultaneously
battling both atrial fibrillation (AFib) and heart failure. The
first-of-its-kind trial aims to provide new insights into more
effective treatment for patients with AFib and heart failure, a
complex combination that has historically presented significant
challenges to physicians.
For many patients, cardiovascular disease can be exacerbated by
comorbidities – additional problems requiring simultaneous
management that make treatment of either condition more
challenging. Clinical trials assessing therapies that can be
deployed in tandem to better manage cardiovascular comorbidities
are also rare. Few companies offer therapies across a clinical care
spectrum that allows for the unique trial designs that can best
provide physicians the insight they need to change the course of
future care decisions.
The new TAP-CHF trial (Evaluating the Treatment of
Atrial Fibrillation in Preserved Cardiac
Function Heart Failure) aims to discover better
management options for patients with AFib and heart failure with
preserved ejection fraction (HFpEF) – a type of heart failure in
which the heart cannot relax and fill with blood effectively prior
to pumping. Combined, these conditions can be very difficult for
doctors to control as they put increased pressure on the pulmonary
arteries, which provide blood flow from the heart to the lungs. For
patients, the two conditions increase the risk of stroke,
hospitalization or even death. Abbott is a leader in developing
medical devices for treating both heart failure and arrhythmias
like AFib and is investigating better treatment options for these
patients with the goal of yielding better outcomes and improved
quality of life.
"Cardiovascular patients often have more than one heart
condition. We believe that we can best help those patients live
longer and better lives by providing their doctors improved therapy
approaches that address the entirety of their heart disease," said
Philip Adamson, M.D., chief medical
officer for Abbott's heart failure business. "Trials that look at
complex heart conditions together promise to offer new insights and
will make a tremendous difference in the outcomes of our patients
now and into the future."
EVALUATING PATIENTS IN NEW WAYS
The TAP-CHF trial will
manage patients in two phases to better help physicians understand
the impact of monitoring fluctuations in pulmonary pressure.
- In the first phase, physicians will deploy either cardiac
ablation or medication to control erratic heart rhythms in AFib
patients with a history of heart failure.
- Following treatment for AFib, all patients will receive the
Abbott Confirm Rx™ insertable cardiac monitor to help physicians
monitor for recurrent abnormal heart rhythms.
- In the second phase, physicians will randomize patients to
receive typical clinical management for heart failure based on
symptom changes or to heart failure management guided by data from
Abbott's CardioMEMS™ HF System, a pulmonary pressure sensor that
can provide doctors with an early warning of worsening heart
failure.
Abbott expects the TAP-CHF trial to enroll up to 100 patients at
10 trial sites in the U.S. At the end of the trial, outcomes of
patients who had their heart failure management guided by data from
the CardioMEMS HF System will be compared to those who received
standard of care (medicine) for their heart failure to determine
which patient group had better outcomes based on recurrence of
AFib, hospitalization or death. The trial will also provide
insights into the effect of catheter ablation in patients with
HFpEF.
"Heart failure in patients with preserved ejection fraction is a
major unsolved public health challenge worldwide, with few
effective avenues of treatment. This is compounded by the fact that
AFib affects nearly half of these patients, increasing the risk of
mortality and increased hospitalization," said Sanjeev Saksena, M.D., principal investigator of
the TAP-CHF trial, clinical professor of medicine at the
Rutgers' Robert Wood Johnson Medical
School and medical director at the Electrophysiology Research
Foundation. "In partnership with innovation leaders such as Abbott,
we've made significant progress in how we treat patients battling
AFib, and we've also made progress in how we manage heart failure.
But to continue to treat people more effectively who are facing
both conditions, we need innovative treatment strategies, fresh
insights and confirmation of new therapeutic approaches."
The TAP-CHF trial is an investigator-initiated phase 4,
sequential, randomized, open label and multicenter prospective
comparative study to address the major health challenge presented
by HFpEF and AFib. The trial is administered by the
Electrophysiology Research Foundation and involves worldwide
leaders in deploying innovative therapies for both conditions.
For U.S. important safety information for the CardioMEMS HF
System, visit:
https://www.cardiovascular.abbott/us/en/hcp/products/heart-failure/pulmonary-pressure-monitors/cardiomems/indications-safety-warnings.html
For U.S. important safety information for the Confirm Rx, visit:
https://www.cardiovascular.abbott/us/en/hcp/products/cardiac-rhythm-management/insertable-cardiac-monitors/confirm-rx/indications-safety-warnings.html
About Abbott
Abbott is a global healthcare leader that
helps people live more fully at all stages of life. Our portfolio
of life-changing technologies spans the spectrum of healthcare,
with leading businesses and products in diagnostics, medical
devices, nutritionals and branded generic medicines. Our 109,000
colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn at
www.linkedin.com/company/abbott-/, on Facebook at
http://www.facebook.com/Abbott and on Twitter @AbbottNews.
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SOURCE Abbott