Many people believe clinical trials are only for the very ill who have no other treatment options. But that’s not the case. In the cardiology field, clinical trials may test new medications to prevent or treat a wide range of diseases. That’s how the drugs called statins came to be widely used to lower cholesterol to prevent a first heart attack or stroke.
Other research studies are designed to identify lifestyle or nutritional support approaches to improving heart health. That’s how Kaiser Permanente researchers learned that medically tailored meals may benefit recently hospitalized patients with heart failure.
And still others compare new surgical approaches and devices for treating structural heart problems. That’s why patients now have the option to have a transcatheter aortic valve replacement rather than open heart surgery.
Alan Go, MD, a senior research scientist at the Kaiser Permanente Division of Research, is the regional medical director for the Kaiser Permanente Northern California Clinical Trials Program. Interventional cardiologist Jacob Mishell, MD, is the medical director of the Structural Heart Program. We spoke with them about the types of cardiology clinical trials and research studies offered to members.
Why does Kaiser Permanente offer clinical trials?
Alan Go, MD: Clinical trials are really about providing enhanced clinical care as a service to our members. Yes, there is a research component, in that we randomize people to a Treatment A versus Treatment B to learn which may be more effective. But it’s really about providing access to novel treatments, elevating our care to give members the opportunity to potentially benefit from the newest treatment options, and to inform the broader medical community about ways to optimize care.
What is structural heart research?
Jacob Mishell, MD: This field came into existence about 12 years ago, and it focuses on fixing mechanical problems with the heart. This might be heart valves that have become too narrow or are leaky, or it may mean repairing holes in the heart. Because the field is so young, and because it is accelerating so quickly, it means that every day we have more questions than answers. I really feel it’s important for us to be involved in the studies trying to answer those questions. Patients, families, and doctors have to make treatment decisions, and the answers we get from these clinical trials give us information that helps guide these decisions.
How can patients learn if they qualify for a clinical trial?
Dr. Go: All of our active clinical trials and research studies are listed on KPStudySearch. We are a trial site for many of the large national studies that are comparing new cardiology treatments. We also have studies designed and led by Kaiser Permanente Northern California. Trials are open to patients throughout Northern California, but, depending on the trial and the type of treatment or procedure it involves, the patient may have to be seen at one of our cardiology subregional hubs, which are in Sacramento, San Francisco, and Santa Clara. But even if that’s the case, there may be follow-up care that can be done in their local facility, so that they don’t have to continue to travel to a specific facility. Also, patients should know they don’t always have to look for these trials on their own. We have active physician investigators who are looking for patients who meet the criteria for the studies that we offer. Our goal is to make sure that every patient has access to all available options for their treatment.
Why should someone take part in a clinical trial?
Dr. Mishell: The most important reason is altruism. We all benefit from those who have taken part in the clinical trials that have led to the treatments we have now that are considered standard of care. Some patients want to be part of what’s less well known and what might have potential advantages. There are other patients for whom uncertainty is hard enough, without adding on participating in a clinical trial. No one is obligated to take part, and if a patient decides they no longer want to participate, they just tell us — and that’s the end of the discussion. We only want people to participate if they feel it is right for them.
Visit the KPStudySearch site for more information.