DETROIT — In an effort toward the research and development of new and potentially breakthrough treatment options for patients with congestive heart failure, DMC Cardiovascular Institute has become the first hospital in Michigan and the seventh hospital across the United States to participate in the INOVATE-HF (INcrease Of VAgal TonE Heart Failure) clinical trial.
INOVATE-HF is a global clinical study to determine the safety and efficacy of the CardioFit system, an investigational implantable device designed to stimulate the vagus nerve in the neck, which may lessen the workload on the heart and thereby help alleviate heart failure symptoms.
The study will explore the system’s ability to reduce heart failure morbidity and mortality and will also investigate whether combined treatment with CardioFit and medical therapy is more effective than medical therapy alone.
“Once again, the DMC is leading the way in delivering the best possible care to the people who rely on us for good heart health,” said Randy Lieberman, M.D., principal investigator of the INOVATE-HF clinical trial at DMC Cardiovascular Institute.
Heart failure is a serious condition in which the heart is unable to provide adequate blood flow to the body. Affecting approximately 23 million people worldwide, heart failure is diagnosed in two million new cases each year and is the leading cause of hospitalization in people over age 65. It is also the most rapidly growing cardiovascular disorder in the United States. Heart failure is caused by a variety of factors that result in damaged heart muscle, the most common of which are coronary artery disease, prolonged high blood pressure, alcohol or drug abuse, and heart valve disorders.
In patients with heart failure, the nervous system is out of balance, and this imbalance increases workload on the heart. The CardioFit system is intended to restore this imbalance by stimulating the vagus nerve in the neck to treat a specific part of the nervous system (called the “parasympathetic” nervous system) that is not treatable with current medical therapies. The CardioFit system consists of a stimulator, a sensor lead and a stimulation lead, which are implanted under the skin of the chest. Once activated, the stimulator’s electrical pulses are transferred via the stimulation lead to the vagus nerve in the neck. Like a pacemaker, the CardioFit System can be programmed on and off via external wireless communication with the device.
Patients who may be eligible for enrollment in INOVATE-HF include those who are aged 18 and over, have been diagnosed with heart failure and are being treated with a combination of medicines, but who continue to have symptoms such as shortness of breath and fatigue.
Developed by medical device company BioControl Medical, CardioFit was first implanted in patients in 2005. Results of a European pilot clinical study suggest there may be a therapeutic role for vagus nerve stimulation in the treatment of heart failure symptoms in patients already on standard medical therapies. BioControl Medical received CE mark for CardioFit in 2009.
For more information on BioControl Medical and the INOVATE-HF trial at DMC Cardiovascular Institute, contact INOVATEHF@BioControl-Medical.com or 1 (877) 494-8770.