Only a fraction of patients who undergo cardiothoracic surgery worldwide participate in clinical trials. Yet, prospective, randomized trials test new and established therapies in a rigorous fashion and can lead to improved care for patients with heart disease. That’s one reason Johns Hopkins Medicine recently joined the Cardiothoracic Surgical Trials Network, says James Gammie, co-director of the Johns Hopkins Heart and Vascular Institute and cardiac surgeon-in-chief for the John Hopkins Health System.
The network is an international consortium, sponsored by the National Heart, Lung and Blood Institute, that provides infrastructure for proof-of-concept studies and interventions to improve outcomes for patients with cardiovascular disease. It is supported by the National Institutes of Health and other research organizations in the United States, Canada and Germany.
Under the leadership of Gammie and Lisa Fornaresio, clinical research program administrator, a team at the Heart and Vascular Institute aims to double its number of clinical trials — from 30 to 60 — and to increase cardiac surgeons from six to 12 within two years.
“Our goal is high-volume, high-quality clinical research that changes practice through prospective randomized trials of surgical interventions,” says Gammie. He notes that the team’s relationships with referring physicians are integral to the program’s success.
“We are grateful to our referring physicians, whom we view as partners in this effort, and we don’t enroll patients without the explicit consent and understanding of their doctors,” says Gammie. “We like to collaborate in the trials with them, and we’ve found that they are incredibly supportive.”
“Our goal is high-volume, high-quality clinical research that changes practice through prospective randomized trials of surgical interventions.” — James Gammie
Best Practices in Cardiothoracic Surgical Trials Research
Membership in the Cardiothoracic Surgical Trials Network has many benefits, says Fornaresio, including the standardization of best practices — from those for screening and enrolling patients to those for setting trial parameters and reporting outcomes. “It’s an excellent organization to connect with, and it helps operationalize research, as there is a wealth of experience across the network,” says Fornaresio, who was previously the director of research and quality for the Heart and Vascular Institute at West Virginia University, where she also had experience with the network. “It’s always helpful to see how other sites are doing things on the ground when you’re running into challenges or jumping hurdles at your own site.”
Gammie and Fornaresio both serve on the network’s Diversity Task Force, which works to further equity and inclusion of underrepresented communities in clinical research studies. The task force is developing processes, educational materials and other mechanisms to help sites address this need, says Fornaresio.
Multisite Randomized Clinical Trials — the Gold Standard of Research
Membership in the Cardiothoracic Surgical Trials Network opens doors to develop and participate in multisite randomized clinical trials. “This is the premier organization — the network of networks,” says Gammie. “It allows for collective outcomes that will teach surgeons around the globe how to take better care of their patients, and it affords the opportunity to answer really pressing clinical questions.”
Before joining Johns Hopkins in 2021, Gammie was involved with multisite clinical trials through the network. He recalls the surprising results in one trial that investigated approaches to mitral valve repair.
“We weren’t sure if we should fix or replace the mitral valve in a certain type of mitral leakage, so we randomized patients in a trial supported by the network,” he says. “We thought that fixing the valve in the traditional way was the way to go. It turned out that at two years, we had failures in almost 60% of patients. That was revelatory! It was amazing, and it stimulated our team to develop a new repair that makes a difference in people’s lives.”
Clinical trials have a history of improving patient care and producing practice-changing innovations, says Jon Resar, director of the adult cardiac catheterization laboratory and of interventional cardiology at The Johns Hopkins Hospital. Resar leads a several clinical trials, including a multisite randomized trial to study the safety and effectiveness of an investigational device for patients with severe mitral regurgitation (mitral insufficiency) from valve degeneration.He wants to tap the opportunities presented by membership in the network.
“Surgeons don’t do a lot of randomized clinical trials, and the cardiothoracic surgery trials network is one of the few organizations that does,” says Resar. “They have a superb track record of doing pivotal studies, and so our involvement is exceedingly important.”
To learn more about clinical trials underway, including those led by Gammie, Resar and others at the Heart and Vascular Institute, search the Johns Hopkins Institute for Clinical & Translational Research website at trials.johnshopkins.edu.
To refer a patient, call 410-955-2800