Clinical trials help advance treatments for heart disease

Research has a place in all aspects of medicine, and cardiovascular medicine is an especially fertile ground for clinical trials.

“Research is the means to advance medicine,” says Ronald Zolty, MD, PhD, an advanced heart failure and transplant cardiologist. “While we have made tremendous progress in advancing the field of cardiology over the past 20 to 30 years, heart disease is still the number one killer of all Americans. That means there is still a lot of room for improvement in treating these diseases.”

Nebraska Medicine heart and vascular specialists are collaborating on a number of clinical trials to improve the treatment of patients with heart diseases such as atrial fibrillation, heart failure, aortic stenosis and peripheral artery disease, to name a few.

“As we have grown to become one of the leading heart centers in the country, the number of national, large-scale clinical trials that we are asked to participate in has also grown,” says Andrew Goldsweig, MD, Nebraska Medicine interventional cardiologist. The medical center is currently involved in more than 70 heart and vascular trials.  “Being involved in these clinical trials allows us to offer the most current and advanced treatments and therapies that are not commercially available elsewhere,” he says.

There are other advantages to going to a medical center that offers clinical trials, notes Dr. Zolty. Not only are you getting the latest and greatest treatments, but as a clinical trial participant, you are being monitored more closely. Clinical trials also provide care at a top medical center, coordinating with the patient’s insurance whenever possible.

One of the trials that Dr. Zolty currently leads involves studying a medication for heart failure patients. Called the Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure (GALACTIC-HF) trial, its goal is to reduce hospital admissions and increase life expectancy for heart failure patients. “The results of the trial have been so positive that the medication is being considered for a fast-track pathway by the Food and Drug Administration (FDA) for rapid submission and early approval,” notes Dr. Zolty.

Another on-going pivotal trial conducted by the heart team is called Assessment of the WATCHMAN Device in Patients Unsuitable for Oral Anticoagulation (ASAP-TOO).  For people with atrial fibrillation, the most common form of arrhythmia, this study is evaluating an implant called the WATCHMAN device, which helps prevent harmful blood clots from forming without the use of lifelong blood thinners. Previously, use of the WATCHMAN required patients to take blood thinners for 45 days after receiving the device. For patients who cannot tolerate blood thinners, the ASAP-TOO trial tests WATCHMAN implantation without blood thinners.

Another current trial, called the Transcatheter Aortic Valve Replacement (TAVR) UNLOAD trial, tests the effectiveness of performing a minimally-invasive valve replacement procedure for people with moderate aortic stenosis. These are patients who otherwise, may have no effective treatment options. The procedure has been highly successful in allowing the heart to pump blood efficiently for people with severe aortic stenosis.

“We have cardiology specialists working together on these trials to bring a deeper level of expertise to every study,” says Dr. Goldsweig. “This ultimately, benefits the patient and advances the field of cardiology as a whole.”