April 14, 2006

BIRMINGHAM, AL — UAB (University of Alabama at Birmingham) researchers are enrolling patients to investigate an implantable device that uses a new method called cardiac contractility modulation (CCM) to change how cells use calcium to strengthen heart muscle contractions in patients suffering from heart failure.

If proven safe and effective, the CCM device “could turn out to be one of the most important therapies on the horizon for patients with congestive heart failure,” said UAB’s principle investigator and cardiologist Jose A. Tallaj, M.D.

Unlike conventional pacemakers, which use “excitatory” electrical signals to regulate heart beat, the CCM method employs a new device called the “Optimizer” to deliver non-excitatory electrical impulses that modify heart cell function.

“What we hope to find is that by stimulating more calcium release into the cell, the strength of heart contractions will increase, since calcium is the electrolyte that allows the heart to contract,” Tallaj said. “By helping the heart pump more effectively, we hope patients will ultimately experience an improvement in symptoms.”

The study, sponsored by the device manufacturer, Impulse Dynamics, of Orangeburg, New York, is designed to investigate the effects of the Optimizer System in approximately 420 moderate to severe heart failure patients at up to 50 sites nationwide. Patients will be randomized into either a group that receives the implantable device or a group that receives current standard drug therapy. Investigators will be comparing objective, functional and quality of life measures, and hoping for improvements in all of these areas, Tallaj said.

“The concept of CCM arises directly from the basic laboratory,” Tallaj said. “The data available is quite compelling in terms of adverse remodeling, hemodynamics and symptoms in patients with heart failure, with minimal risk to the patient. As this technique is optimized, I think it will be able to benefit more patients than other therapies on the market such as cardiac resynchronization therapy.”

Heart failure is a disease that affects more than 5 million Americans and an estimated 15 million patients worldwide. The disease can be caused by damage to the heart muscle from injuries such as heart attacks, untreated coronary artery disease or persistent high blood pressure, or result from genetic or molecular abnormalities or infections. Symptoms of heart failure begin to appear as the heart becomes progressively too weak to pump enough blood to meet the energy needs of the body.

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