To further support the possibility that therapy to resynchronize the
failing heart's beating action may lengthen life span, in addition to keeping
patients more healthy, Medtronic, Inc., today announced enrollment
of the first patients in a major new European study with implications for
thousands of the world's heart failure patients.
The study, called the Cardiac Resynchronization - Heart Failure (CARE-HF)
trial, is the first 18-month study in Europe to evaluate 800 patients for the
effect of the new device-based therapy on hospitalization, death and quality
of life. Positive results would add significant validity to the combination
of device-based therapies with drug regimens in the treatment of heart
Heart failure affects more than 22.5 million persons worldwide, including
six million Europeans, with approximately 500,000 new patients diagnosed each
year. It is a major cost and quality-of-life issue for people with the
disease and is characterized by frequent hospital admissions.
Physicians participating in the CARE-HF trial will study whether patients
whose heart conditions do not require device therapy will benefit from a new,
specialized implantable resynchronization device intended to restore
synchronized beating to the left and right sides of the failing heart for more
efficient pumping action. The new study asks: What is the added effect, if
any, of cardiac resynchronization therapy on the life span and health of heart
failure patients already receiving diuretics and optimal medical therapy?
The CARE-HF study, a randomized controlled trial, is to take place at
approximately 100 heart centers in 12 European countries. Its 800 patients --
400 receiving cardiac resynchronization associated with optimal
pharmacological therapy and 400 who receive optimal pharmacological therapy
only -- will be in New York Heart Association Classes III or IV, indicating
that their chronic heart failure has dramatically progressed. Patients will
be followed for at least 18 months.
The first patients to be enrolled in the CARE-HF trial on January 9, 2001,
were a 70-year-old female at the Centre Hospitalier Universitaire in Rennes,
France, and a 50-year-old male at the University Hospital Skejby in Aarhus,
Denmark. Both suffer from advanced heart failure (New York Heart Association
Classes III or IV) with ventricular conduction delays and are currently on
multiple medications such as diuretics, ACE inhibitors and beta-blockers.
A steering committee of cardiologists are leading the trial, headed by
Chairman Prof. J.G.F. Cleland, of Kingston-upon-Hull, U.K. The committee
includes Prof. Jean Claude Daubert of Rennes, France; Prof. Erland Erdman of
Cologne, Germany; Dr. Daniel Gras, Paris, France; Prof. Lukas Kappenberger of
Lausanne, Switzerland; Prof. Werner Klein, Graz, Austria; Prof. Luigi Tavazzi,
Pavia, Italy, and Prof. Nick Freemantle, Birmingham, U.K.
The committee has noted that previous and concurrent studies are
suggesting the efficacy of cardiac resynchronization but that a direct
comparison to a combination drug/device therapy is essential before physicians
establish its place in the long-term care continuum. "Despite advances in
drug treatment, many patients with heart failure still have severe symptoms,"
said Prof. Cleland. "We feel that a successful, positive conclusion to this
landmark study will help us quantify the effect of resynchronization and allow
us to research it in concert with pharmaceuticals in affecting disease
progression. We know the effectiveness of drugs is highly variable and
patient-specific; now we must ascertain whether device-based therapies can
play the role we think they can."
Four hundred patients randomized to cardiac resynchronization therapy are
to receive one of two implantable systems used with Attain(TM) left-heart
-- Implanted under the skin in the chest area, the
cardiac resynchronization system delivers electrical impulses via two
insulated wires threaded through veins inside the right atrium (upper
chamber) and ventricle (lower chamber). A third wire is maneuvered
through a vein on the heart's surface that leads to the left ventricle.
The device was commercially released to the European market in 1998 and
is currently undergoing clinical evaluation in the United States.
- -- The new implantable cardiac resynchronization
system designed to allow physicians to program and control the beating
action of the right and left sides of the heart independently. It also
includes heart failure-specific diagnostic capabilities intended to
monitor a patient's heart rate trends and activity levels. Clinical
evaluation is under way in Europe.
Data from CARE-HF and other European studies involving Medtronic cardiac
resynchronization therapies will complement those now being collected in the
U.S./Canada Multi-center InSync Randomized Clinical Evaluation (MIRACLE) study
which is also evaluating a comparable group of about 300 patients at about 45
U.S. and Canadian centers.