Someone wearing a lab coat and stethoscope holding an anatomical model of a heart in their hands
A multi-institutional study will be assessing a promising new heart failure therapy that recruits the heart’s own conduction system to pace it in a more natural manner. (Getty Images)

Multi-institutional project awarded $31M to study promising heart failure therapy

The study will assess a new method for pacing the heart that could potentially improve health outcomes for patients diagnosed with heart failure and conduction system disease.

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

The research will be led by Kenneth Ellenbogen, M.D., 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, M.D., Ph.D., an associate professor at the Baylor College of Medicine; and Richard Holubkov, Ph.D., a professor and biostatistician at the University of Utah School of Medicine.

“We’ll be assessing a new way of pacing the heart that we think has the potential to revolutionize how we treat patients who are struggling with abnormal heartbeats,” Ellenbogen said. “Once the study begins, it will likely be one of the largest heart pacing clinical trials happening in the world over the next few years.”

Heart failure occurs when the heart struggles to pump enough blood to support the body’s needs, often resulting in breathing difficulties, swelling in the lower body and general fatigue. Affecting more than 6 million people in the United States, heart failure is one of the leading causes of hospitalization and increases the risk of premature death.

Approximately one-third of heart failure cases are due to conduction system disease, when the electrical system that controls the heart’s rhythm and rate becomes disrupted. In a healthy heart, electrical signals travel from the top of the heart to the bottom, prompting the heart to beat. However, when the signals are not produced properly or travel along a different path, the heart will start to beat too quickly, too slowly or at an irregular pace.

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 pulses to specific muscle sites within the heart to help coordinate regular pacing.

“Biventricular pacing is a common strategy, as it often can improve heart function, reduce hospitalization and prolong a patient’s lifetime. However, 30-40% of patients with this treatment do not experience any improvement to their condition,” Ellenbogen said.

In this new study, Ellenbogen and his collaborators will assess a new method for pacing the heart, called conduction system pacing. This strategy works by sending electrical pulses from a pacemaker to the heart’s conducting cells, which are responsible for carrying 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 manner,” Ellenbogen said. “Conduction system pacing is also a simpler implant procedure and is anticipated to be less costly to heart failure patients.”

The idea of conduction system pacing has been around for about 20 years, but it initially proved to be difficult to implement. Over the last few years, Ellenbogen has been working with Pugazhendhi Vijayaramon, M.D., a cardiologist at the Geisinger Medical Center, to develop improved techniques for this strategy. Past studies have shown that conduction system pacing is a promising method for safely restoring the heart’s natural pace and improving patient health. Through this study, the researchers have a chance to better understand how the method compares to the standard practice.

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

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

As part of the study, Greg Hundley, M.D., director of the VCU Pauley Heart Center and chair of the Division of Cardiology in the VCU School of Medicine, will direct the Imaging Core Lab for the study. The Core Lab will oversee the cardiovascular imaging performed at all 65 partnering sites and analyze roughly 10,000 echocardiograms and 1,000 cardiac MRIs as they are collected from the enrolling sites. This data will give the research team important information about the heart’s function and structure, including size, anatomy, valves, perfusion and blood flow.

The award has been approved pending completion of a business and programmatic review by PCORI staff and 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 better-informed health care decisions.