It's a fact with which doctors in Montefiore's Cardiac Research Institute for Clinical Trials are all too familiar.It's a fact with which doctors in Montefiore's Cardiac Research Institute for Clinical Trials are all too familiar.
"Believe it or not, it's difficult to get patients to enroll in cardiac studies," says Auris Browne, MD, Director, Clinical Trials and Regulatory Affairs, Cardiology. "There's sensitivity with the heart that doesn't exist with other organs."
At any given time, Montefiore is actively recruiting patients for dozens of cardiac trials, including three new studies that began in 2011. The first is a National Heart, Lung, and Blood Institute-sponsored trial that is exploring the safety and efficacy of injecting stem cells into the heart muscle of Left Ventricular Assist Device recipients.
The second study is a Phase III trial called INOVATE-HF, which is aimed at demonstrating the long-term safety and efficacy of vagus nerve stimulation with the CardioFit® system for the treatment of subjects with heart failure. CardioFit® is an implantable congestive heart failure modulator that reduces the heart rate, improves ventricular volumes and restores regular cardiac rhythm.
Through the third study, Montefiore cardiologists are evaluating the effect of 48 hours of IV treatment with omecamtiv mecarbil (a novel, small-molecule, direct activator of cardiac myosin) in subjects with left ventricular systolic dysfunction who are hospitalized for acute heart failure.
"We spend a lot of time with patients, explaining the benefits-both intrinsic and extrinsic-that are associated with their participation in a clinical trial," adds Roger Swayze, RN, BSN, MBA, Director, Clinical and Regulatory Affairs, Department of Cardiovascular and Thoracic Surgery and Department of Surgery. "Once patients better understand the big picture they are more willing to enroll."
Which brings Browne and Swayze to their next challenge -retention.
Swayze explains that they maintain an open line of communication with clinical trial patients-calling them to check in, making sure that they have transportation to appointments, following up after the appointment to see how they are doing.
"We like to say that our clinical trial participants are our 'VIPs,'" he jokes. "After all, they are playing a very important role in advancing the care we deliver."
Browne and Swayze's collective ability to connect with patients and develop strong relationships has worked to Montefiore's benefit.
"We are consistently among the top enrolling sites for all of our clinical trials," says Browne. "This has helped us garner the attention of institutions such as the National Institutes of Health that select sites based upon their ability to enroll and retain participants."
When asked what drives them to come to work each day, both agree that it's both the leadership and personal satisfaction.
"The leadership here is passionate about research and the critical role that it has in improving patients' lives," says Swayze. "It really drives home the importance of what you are doing and makes you want to succeed."
"What I always love to see is the difference in a patient from the start of a trial to completion," says Browne. "A patient may begin a trial unable to take more than a few steps before resting, then months later you see the person and he or she is walking two miles nonstop. It really makes me feel great to know I had a role in that progression."
To learn more about all of the clinical trials that are currently available to patients at the Cardiac Research Institute, visit www.montefiore.org/research-and-clinical-trials.