Heart failure

Multi-institutional project receives $31 million to study promising treatment for heart failure

Virginia Commonwealth University School of Medicine is part of a $31 million multi-institutional study focused on evaluating a new method of cardiac pacing in people with heart failure and heart failure. conduction system disease. Funding was provided by the Patient-Centered Outcomes Research Institute.

The research will be led by Kenneth Ellenbogen, MD, director of clinical cardiac electrophysiology and pacing at the VCU Pauley Heart Center and the Martha M. and Harold W. Kimmerling Chair of Cardiology at the VCU School of Medicine; Mihail G. Chelu, MD, Ph.D., associate professor at Baylor College of Medicine; and Richard Holubkov, Ph.D., professor and biostatistician at the University of Utah School of Medicine.

“We will be evaluating a new way to stimulate the heart that we believe has the potential to revolutionize the way we treat patients with abnormal heartbeats,” Ellenbogen said. “Once the study begins, this will likely be one of the largest cardiac pacing clinical trials to take place in the world in the next few years.”

Heart failure occurs when the heart has difficulty pumping enough blood to meet the body’s needs, often leading to difficulty breathing, lower body swelling and general fatigue. Affecting more than 6 million people in the United States, heart failure is a leading cause of hospitalization and increases the risk of premature death.

About a third of cases of heart failure are due to conduction system disease, when the electrical system that controls heart rhythm and rate is disrupted. In a healthy heart, electrical signals travel from the top of the heart down, prompting the heart to beat. However, when the signals are not produced correctly or follow a different path, the heart begins to beat too fast, too slow, or at an irregular rate.

Biventricular pacing is the standard method for treating patients diagnosed with both heart failure and conduction system disease. This is done through a pacemaker, a small device implanted under the skin that generates electrical impulses to specific muscle sites in the heart to help coordinate regular stimulation.

“Biventricular pacing is a common strategy because it can often improve heart function, reduce hospitalizations, and extend a patient’s lifespan. However, 30-40% of patients with this treatment see no improvement in their condition,” Ellenbogen said.

In this new study, Ellenbogen and his collaborators will evaluate a new method of stimulating the heart, called stimulation of the conduction system. This strategy works by sending electrical impulses from a pacemaker to the heart’s conductive cells, which are responsible for carrying the electrical signals.

“This strategy is advantageous because we’re essentially recruiting the heart’s own conduction system and pacing the heart in a more natural way,” Ellenbogen said. “Conduction system stimulation is also a simpler implantation procedure and should be less expensive for patients with heart failure.”

The idea of ​​conduction system stimulation has been around for about 20 years, but it initially proved difficult to implement. Over the past several years, Ellenbogen has worked with Pugazhendhi Vijayaramon, MD, a cardiologist at Geisinger Medical Center, to develop improved techniques for this strategy.

Previous studies have shown that stimulation of the conduction system is a promising method to safely restore the heart’s natural rhythm and improve patient health. Through this study, researchers have a chance to better understand how the method compares to standard practice.

“More than 100,000 patients are treated with cardiac resynchronization devices each year in the United States,” Ellenbogen said. “This research represents an important step in providing more care options for patients with heart failure.”

For this project, the research team will examine the efficacy and safety of the conduction system and biventricular pacing. Involving more than 2,000 patients at 65 sites across the United States and Canada, the study will assess changes in each patient’s heart function, health outcomes and quality of life. Clinical trials are expected to begin later this year.

As part of the study, Greg Hundley, MD, director of the VCU Pauley Heart Center and chairman of the division of cardiology at the VCU School of Medicine, will lead the Imaging Core Lab for the study. The Core Lab will oversee cardiovascular imaging performed at the 65 partner sites and analyze approximately 10,000 echocardiograms and 1,000 cardiac MRIs as they are collected at enrollment sites. This data will provide the research team with important information about the function and structure of the heart, including size, anatomy, valves, perfusion and blood flow.

The award was approved pending the completion of a review of activities and programs by PCORI staff and the issuance of a formal award contract.

PCORI is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make more informed health care decisions.