The CardioFit system works by stimulating the vagus nerve, a key pathway to the brain. Vagus nerve stimulation has long been used to treat epilepsy, but its potential in the treatment of congestive heart failure is a more recent development. CardioFit has already been tested in a pilot study in Europe with positive results.
“Congestive heart failure, when the heart becomes weakened and cannot pump as much blood as it should, is the most rapidly growing cardiovascular disorder in the United States,” said George Sokos, DO, a heart failure cardiologist at AGH and principal investigator for the new clinical trial, known as INOVATE-HF. “We treat most of our patients with medications that can help relieve their symptoms but do not always stop the heart’s deterioration. We are very eager to learn through the INOVATE-HF study whether the CardioFit system offers patients with this disease a new therapeutic option that will improve and extend their lives.”
The main purpose of the study is to determine if the CardioFit system is beneficial and safe for the treatment of heart failure. The study will continue for a total of up to 5½ years. During that time period, patients will visit a physician or research nurse regularly. They will also be required to complete questionnaires and undergo tests similar to those taken during the evaluation stage.
The INOVATE-HF study is recruiting patients who will be randomly placed into two groups: one will have the CardioFit system implanted, and one will not. The study will determine whether the combination of the implanted device and medical therapy is more effective than medical therapy alone in treating congestive heart failure.
Eligible patients must be age 18 or older, diagnosed with congestive heart failure and suffering from heart failure symptoms such as shortness of breath or fatigue despite treatment with a combination of medicines. Up to 650 patients at 30 centers in the United States and Europe will be enrolled in the trial, which is being offered in the Pittsburgh area only at AGH.
“The results of earlier studies have indicated that vagus nerve stimulation may have added therapeutic value beyond traditional heart failure treatments,” said Dr. Sokos. “With INOVATE-HF, we can investigate CardioFit’s potential benefits among a large group of patients. By treating the parasympathetic nervous system, CardioFit has the potential to deliver a paradigm-shifting improvement to our existing capabilities.”
The CardioFit System is designed to stimulate the vagus nerve in the neck to stimulate the parasympathetic branch of the autonomic nervous system, which may lessen the workload on the heart.
The CardioFit system comprises three parts: a sensing lead, or standard pacemaker-type insulated wire to the heart, a stimulator that is similar to a pacemaker, and a stimulation lead, a specialized wire placed on a nerve in the neck that helps send signals that regulate the heart.
CardioFit is developed and marketed by BioControl Medical, a medical technology company based in Yehud, Israel and New Hope, Minn. Results of INOVATE-HF will be used to support a Premarket Approval Application to the U.S. Food and Drug Administration (FDA) for market clearance of CardioFit.
The CardioFit system may decrease heart failure symptoms and slow the disease’s progression, but the benefit is not guaranteed. BioControl is committed to ensuring that the trial provides invaluable information that will help create better treatments for heart failure patients.
“At AGH and throughout West Penn Allegheny Health System (WPAHS), we are proud of our leadership role in providing advanced care for patients with complex diseases of the heart and blood vessels, said Srinivas Murali, MD, Director of the Division of Cardiovascular Medicine and Medical Director of the Cardiovascular Institute at WPAHS. Our cardiovascular research teams are continuously pushing the boundaries of conventional medicine through cutting edge clinical trials like the INNOVATE-HF study.”
For more information, talk to your heart failure physician or call Sarah Sherry, research coordinator, AGH, at 412.359.3253.