Morton Plant Hospital Joins Worldwide Clinical Trial for Congestive Heart Failure Treatment
CLEARWATER, Fla., (December 10, 2013) - Morton Plant Hospital is one of 80 sites worldwide and the first in the Tampa Bay area to participate in a clinical trial designed for heart failure patients. Called INOVATE-HF, the study uses an electrical stimulation device called CardioFit®, to rebalance the two branches of the autonomic nervous system with the goal of alleviating some of the adverse symptoms related to congestive heart failure.
The clinical trial is a prospective, randomized, controlled study to determine the safety and efficacy of the CardioFit, an implantable electrical stimulation device designed to improve heart function in patients with congestive heart failure. The study will evaluate the system’s potential to reduce hospitalization and death among patients with heart failure, while also exploring whether combined treatment with CardioFit and prescription drug therapy is more effective than drug therapy alone in improving a patient’s quality of life.
In healthy people, there is a balance in the nervous system between the sympathetic branch and the parasympathetic branch. The sympathetic branch activates the “fight or flight” response during stress and increases heart rate and blood pressure, while the parasympathetic branch creates a calming effect on the heart through signals carried by the vagus nerve, which runs down the right side of the neck.
“In congestive heart failure, there is an imbalance between the two branches and the sympathetic branch goes into overdrive while the parasympathetic branch is underactive,” said Jose Gallastegui, MD, electrophysiologist, director of electrophysiology and arrhythmia, Morton Plant Hospital, and co-principal investigator of the study. “This imbalance can lead to added stress on the heart and progressive deterioration of function. The goal of the CardioFit device is to keep the balance in check and prevent the heart from overworking unnecessarily, helping patients to potentially have more heart function and a better quality of life.
“In the past, we’ve been able to slow down an overactive sympathetic branch with medication, but when we can also stimulate the vagus nerve to produce a counter-balancing calm to the heart, we can have a much better chance of alleviating heart failure symptoms and possibly reversing some of the deterioration caused by this condition,” said Dr. Gallastegui.
According to product developer BioControl Medical, the system consists of a stimulator implanted under the skin, with a sensor lead that connects to the right ventricle of the heart, and a stimulation lead which connects to the vagus nerve in the neck. Once activated, the stimulator’s electrical pulses are transferred to the vagus nerve. At the same time, the sensor lead monitors changes in heart activity and turns stimulation on or off accordingly.
“What we hope to learn from this study is how can we best manage heart failure and what combinations of treatment modalities provide the most ideal result,” said John Ofenloch, MD, cardiovascular surgeon, Morton Plant Hospital. The device is implanted into the patient by two physicians – an electrophysiologist and a cardiovascular surgeon in Morton Plant’s hybrid operating suite.
The study team also consists of H. Andrew Hazlitt, MD, electrophysiologist, Morton Plant Hospital and Yves Gabriel, MD, vascular surgeon, Morton Plant Hospital. The study is currently in its third and largest phase. For more information, log on to http://clinicaltrial.gov.
About Morton Plant Hospital
Established in 1916, Morton Plant Hospital is a 687-bed facility. Our commitment to improving the health of everyone we serve is reflected in our community partnerships and many honors. Morton Plant is the only hospital in the United States to have been awarded Top 100 Hospital designations by the Thomson Reuters 100 Top Hospitals: National Benchmarks for Success for a consecutive 13 years. Other hospital honors include: “Baby-Friendly” hospital status from the World Health Organization (WHO) and the United Nations Children’s Fund (UNICEF) for its efforts to support mothers’ decision to breast feed and received Florida Hospitals Association’s Innovation of the Year in Patient Care award. Morton Plant Hospital is located at 300 Pinellas St., Clearwater, Fla.
About BayCare Health System
BayCare Health System is a leading community-based health system in the Tampa Bay area. Composed of a network of 11 not-for-profit hospitals, outpatient facilities and services such as imaging, lab, behavioral health and home health care, BayCare provides expert medical care throughout a patient’s lifetime. With more than 200 access points conveniently located throughout Tampa Bay, BayCare connects patients to a complete range of preventive, diagnostic and treatment services for any health care need.
BayCare’s family of hospitals are: Mease Countryside, Mease Dunedin, Morton Plant, Morton Plant North Bay, St. Anthony’s, St. Joseph’s, St. Joseph’s Children’s, St. Joseph’s Hospital-North, St. Joseph’s Women’s, South Florida Baptist, and Winter Haven. For more information, visit BayCare on the Web at www.BayCare.org.