MINNEAPOLIS–(BUSINESS WIRE)–Medtronic, Inc. today
announced the initiation and first patient enrollment in a clinical study that
will evaluate gaps in the implementation of evidence-based treatment guidelines
among chronic heart failure patients post-hospital discharge. The IMPROVE HF
Bridge Study will analyze approximately 120 patients from four different
centers in the United States
for a period of six months following their initial hospital stay. Patients will
be cared for in the outpatient setting by either a primary care physician
alone, or by both a heart failure specialist and primary care physician
throughout the study.
“With primary care physicians managing the ongoing follow-up
and treatment of heart failure patients once they are discharged from the
hospital, this study will provide new insight on what is happening from a
treatment perspective once this care is transferred,” said Mihai Gheorghiade,
M.D., principal investigator and professor of medicine and surgery, Feinberg
School of Medicine at Northwestern University, Chicago. “It is our hope that
through ongoing collaboration between cardiologists and primary care
physicians, we can increase adherence to treatment guidelines and ultimately
enhance the quality of care and reduce hospital readmission rates among heart
failure patients.”
The prospective, randomized study will also explore the
feasibility of implementing Class I, Level A guideline recommendations set
forth by the American
College of Cardiology and
American Heart Association. These include drug therapy (ACE inhibitors,
beta-blockers), device therapy (implantable cardiac defibrillators, cardiac
resynchronization therapy), heart failure education and anticoagulation for
atrial fibrillation. Findings from this study will inform whether a larger
trial to bridge the gap between guideline recommendations and actual practice
will be initiated.
Each year more than 1 million patients are admitted to the
hospital due to heart failure1, and many of these patients are readmitted
within 30 days due to the complex nature of managing their disease.2 While
numerous evidence-based, life-prolonging drug and device therapies have been
developed and are now widely available to reduce morbidity and mortality and
improve quality of life for heart failure patients, these innovative therapies
continue to be underutilized in both the inpatient and outpatient settings.3
For instance, cardiac resynchronization therapy is broadly underused in
indicated patients despite a growing body of clinical evidence showing its
benefits in reducing heart failure hospitalization and death.4 IMPROVE HF, the
first-of-its-kind, prospective study involving approximately 35,000 heart
failure patients from 167 U.S. cardiology practices, was designed to quantify
and improve quality of care for heart failure patients by promoting the use of
these evidence-based, guideline-recommended therapies.
“The commencement of the IMPROVE HF Bridge Study underscores
our commitment to ensuring that all heart failure patients receive the best
possible care through clinically-validated treatment options based on the
individuals specific disease-state,” said Pat Mackin, president of the Cardiac
Rhythm Disease Management business and senior vice president at Medtronic.
About the IMPROVE HF Bridge Study
Heart failure patients in the study will be randomized post-hospital discharge
to standard of care by a primary care physician (observational arm) or care
directed by a heart failure specialist (assessment arm). The heart failure
specialist will perform a comprehensive assessment of patients in the
assessment arm within one week of discharge, which will include a health care
utilization review and a full physical exam, and may also include specific
diagnostic testing as determined by the study investigators. While heart
failure specialists will not manage patients directly, they will collaborate
with primary care physicians after the one week visit is complete to make
recommendations for care, including medication needs and potential device
therapy indications.
Patients in the assessment arm will be followed by the heart
failure specialist at 30 days, three months and six months for re-evaluation.
The enrollment period is expected to take approximately 15 months from first
enrollment, with total study duration of approximately 22 months.
In collaboration with leading clinicians, researchers and
scientists worldwide, Medtronic offers the broadest range of innovative medical
technology for the interventional and surgical treatment of cardiovascular
disease and cardiac arrhythmias.
About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical
technology – alleviating pain, restoring health, and extending life for
millions of people around the world.
1 Centers for Disease Control and Prevention [CDC], 2006.
2 Jencks, S, et al. Rehospitalizations among Patients in the Medicare Fee-for-Service Program. N Engl J Med 2009;
360:1418-1428.
3 Fonarow GC. Rev Cardiovasc Med. 2002;3:S2-S10.
4 Anand, I, et al. Cardiac Resynchronization Therapy Reduces the Risk of
Hospitalizations in Patients With Advanced Heart Failure. Circulation. 2009;
119: 969-977.
Posted by Sean Fenske, Editor-in-Chief, MDT
