One-of-a-kind Clinical Trial to Study Use of Pacemakers

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Northwestern University’s Feinberg School of Medicine received a $15 million grant to conduct a five-year trial that will investigate whether utilizing pacemakers to administer beta-blocker therapy improves survival in patients.

In February, Northwestern University’s Feinberg School of Medicine announced it had received a $15 million grant from the National Heart, Lung and Blood Institute to conduct a five-year, multicenter randomized trial that will investigate whether pacemaker facilitated administration of beta-blockers improves survival in patients with post-MI bradycardia or heart block.

Jeffrey Goldberger, MD, professor of medicine at Feinberg School of Medicine and director of Cardiac Electrophysiology at Northwestern Memorial Hospital, is the national principal investigator for the study, which is officially called the PACE-MI TRIAL: PACEmaker and Beta-Blocker Therapy after Myocardial Infarction Trial.

The study, which is seeking to enroll more than 1,100 patients, will, according to Goldberger, help clinicians determine the frequency with which low heart rates cause problems in heart attack patients. In a press release distributed to announce the funding award, Goldberger said that “Identifying and enrolling these patients will be challenging for a variety of reasons. These patients represent a small subset of all heart attack patients and they are more elderly with other co-morbidities and personal factors preventing participation. Nonetheless, this research question addresses a significant public health issue.”

Investigators will face other challenges, as well, because pacemaker implantation to facilitate beta-blocker therapy post-MI in patients with asymptomatic bradycardia is not currently covered by Medicare. “We had petitioned Medicare to alter their coverage policy for this indication. Because of the lack of data in this specific cohort, Medicare did not expand their coverage guidelines for this indication,” Goldberger said.

The lack of direct Medicare coverage means PACE-MI is a one-of-a-kind event, claimed Goldberger, who views the study as “our only opportunity ever to address this question.” Goldberger said that if the trial does not meet enrollment goals, “it is unlikely any funding agency would be willing to try again. It is also the only opportunity to gather the data CMS will require to change their coverage policy. We have a call out to all cardiologists to help with recruitment. The success of the study requires collaboration with cardiologists nationwide to identify and refer these patients to a locally enrolling center.”

Cardiologists who are interested in learning more about the trial and how to refer patients for enrollment can visit the official PACE-MI website.

For more information:

Post—myocardial infarction β-blocker therapy: The bradycardia conundrum. Rationale and design for the Pacemaker and β-blocker therapy post-MI (PACE-MI) trial

Entry at ClinicalTrials.gov: Effectiveness of Combining Beta-Blocker Therapy and a Pacemaker Following a Heart Attack (The PACE-MI Trial)

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