MICHR Named Data and Clinical Coordinating Center for $14M REVIVE-IT Heart Failure Study
Updated 2/9/11 - The National Heart, Lung and Blood Institute (NHLBI) has awarded the University of Michigan a five-year contract called REVIVE-IT, which will compare therapy with a left ventricular assist device to optimal medical management in advanced heart failure patients not eligible for heart transplantation. The $14M award combines a $5M grant from the NHLBI with a contract of up to $9.5M from HeartWare, the sponsor of the device that will be used in the study. Michigan Institute for Clinical & Health Research (MICHR) will be the Data and Clinical Coordinating Center for the study, providing support in a variety of areas, including project management and biostatistics.
Principal Investigators of this study are U-M faculty Keith Aaronson, MD, MS, Associate Professor, Cardiovascular Medicine and Francis Pagani, MD, PhD, Professor, Cardiac Surgery. A third PI, Robert Kormos, MD, is Professor of Surgery at the University of Pittsburgh, another Clinical & Translational Science Award (CTSA) institution. Competition for this award included a joint proposal from Duke, Cleveland Clinic, and their clinical research organizations.
“There are many people throughout the Health System who made substantial contributions to the development of our proposal but we particularly want to acknowledge the enormous role that MICHR played in making this possible,” said Aaronson and Pagani. “There is simply no way that we would have been able to put together this proposal without the efforts and outstanding work of MICHR, nor would we be able to perform the planned work without having MICHR’s support.”
REVIVE-IT stands for Randomized Evaluation of VAD InterVEntion before Inotropic Therapy. The goal of the study is to explore the potential benefit of mechanical circulatory support therapy using ventricular assist devices (VADs) in functionally-impaired advanced heart failure patients, not eligible for heart transplantation, who have not yet developed serious consequences from their disease. The study will serve to inform a pivotal trial directed at a large and growing patient population for whom VADs could offer substantial benefit beyond current medical therapies. The VAD to be used in REVIVE-IT is an investigative battery-operated device, called the HVAD (HeartWare Corporation) that is implanted to maintain the pumping ability of a heart that cannot effectively pump on its own.
The study aims to catch these patients earlier, when they would normally be treated with optimal medical therapy, and evaluate whether the use of a VAD can improve their outcomes. “Finding patients to enroll in the study will be based upon severity of illness,” says Kevin Weatherwax, Manager, Project Management and Monitoring at MICHR. “The key is that patients need to be sick enough, but not have advanced symptoms that already make them candidates for the use of a commercially-available VAD.”
Weatherwax will be responsible for overseeing the daily operations of the study, under the supervision of the principal investigators. Several other MICHR teams, including the MICHR IND/IDE Investigator Assistance Program, Project Management & Monitoring, Data Management, Biostatistics, and Informatics, will also provide support for the study. “This is a multi-program effort within MICHR,” Weatherwax says. “This is one of our first real opportunities to collaborate, and it worked very well.” Weatherwax adds that MICHR will hire additional employees to accommodate the scope of this study.
Read the official University of Michigan Health System news release and watch a short video featuring Drs. Aaronson and Pagini.