PI Insights From A Heart Failure Trial: Part 2

By Dan Schell, Chief Editor, Clinical Leader

This is part 2 of my interview with Jennifer Cowger, MD, the co-principal investigator of the Abbott TEAM-HF trial. In part 1, I said I was shocked to find out that Cowger may be the first female in the U.S. to be named co-PI of this large (850 patients at 75 sites worldwide) of a trial. For context, the TEAM-HF trial is designed to measure pulmonary artery pressure data using Abbott’s CardioMEMS HF System to identify advanced heart failure patients at high risk of mortality who could benefit from a HeartMate 3 left ventricular assist device (LVAD, or heart pump) earlier in their disease progression. In part 1, Cowger talked about her role as a PI including trial design and meetings with the FDA. Here, she elaborates more on some of her tasks specific to this trial.

EDUCATION/CONSENT ISN’T ONE AND DONE

There are a few factors that make the TEAM-HF trial a little unusual, and subsequently, affect how Cowger as a PI, is involved. First, the trial is designed for patients early in their disease progression. It’s a proactive step designed for “ambulatory walkie-talkie” patients, as Cowger would say. Participating in the trial means the patient will first have the CardioMEMS sensor implanted into the pulmonary artery, which is not a high-risk procedure. Those who are appropriate to continue in the trial will be randomized to either medical management or an actual surgical procedure of the LVAD. That leads to another of those unusual factors: an increased emphasis on consent and education. Early on, Cowger and the site staff do hands-on training of patients regarding the purpose of the trial, what a LVAD is, and what a patient should expect from being in the trial. If they're still interested in participating, a research coordinator conducts a more formal screening of all the I/E criteria, and then provides additional in-depth education on the trial’s risks and benefits. “In this trial, the term ‘informed consent’ becomes omnipresent, and is probably more important than many of the consents I've ever done,” says Cowger. “We have to make sure, as they go forward, they're comfortable and aware of all aspects of the trial, which is why the education and consent portions of this trial can’t be a ‘one-and-done’ task; they need to be ongoing.” She adds that, to eliminate any bias coming from her as the PI, it’s important that some of that education comes from the facility’s VAD or research coordinators as well as nurses.

All of those separate touchpoints from different people also help ensure the patient fully understands the risks and burdens of the trial as well as their responsibilities. For example, one of the most common questions from any trial participant is how much time they will have to invest. This, Cowger, says, is another one of the unusual aspects of the TEAM-HF trial — there's not a significant added burden for patients to participate. Most of the follow-up actually falls within what she calls “standard of care;” a normal number of visits/frequency that a patient would go through even if they were not in the trial. “I think that's important for patients to hear these days considering there are many trials in which we're adding on unnecessary visits,” Cowger says.

ARE TRIALS TOO COMPLEX?

That unnecessary visits comment led me to ask a question that had nothing to do with this Abbott trial. During the past year, I’ve heard so many people speak about how complex trials have become with so many exploratory endpoints that, supposedly, end up delaying trials or adding burden to patients. Considering I was speaking to a PI with plenty of experience in trial design, I thought I’d ask her opinion on this frequently cited criticism. “Simply put, science is not convenient, easy, or cheap. There is always an opportunity to ‘lean’ things, such as maybe some of the bloodwork we're getting or the complexity of the follow up. But ultimately, it depends on the level of the trial. For example, TEAM-HF is a trial with less-ill patients that requires a surgical intervention. So, there’s no cutting corners. It's not going to be easy, and it's not going to be quick. So, I think it is necessary we ‘dot the I’s and cross the T's’ in trials that are a high enough clinical risk. There are some trials that are of a lower clinical risk, especially non-device trials, which absolutely can be leaned. But this isn’t something we can do for many of the trials I’m involved with.”