NIH Awards $10 Million Grant To NYU Langone Medical Center To Study Management Of Ischemic Heart Disease In Patients With Chronic Kidney Disease
New International Study to Compare Treatment Options for 1,000 Participants
NYU Langone Medical Center announced today it received a $10 million grant from the National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH) to study the best management strategy for patients with stable ischemic heart disease and advanced chronic kidney disease (CKD). The ISCHEMIA-CKD (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches – Chronic Kidney Disease) trial is a multicenter randomized controlled trial that will study approximately 1,000 patients with CKD, which causes impaired kidney function that may ultimately result in kidney failure and dialysis, and at least moderate ischemia (reduced blood flow to the heart caused by narrowed heart arteries).
This international study will involve approximately 300 medical centers in the U.S. and more than 30 other countries worldwide collaborating on this four-year research effort to help a population that is often excluded from cardiovascular trials. The clinical trial is designed to run in parallel with an $84 million NIH grant awarded in 2011 to NYU Langone Medical Center for the ISCHEMIA (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) trial led by Judith Hochman, MD, at NYU Langone Medical Center and David Maron, MD, from Vanderbilt University. ISCHEMIA-CKD differs from the main ISCHEMIA trial in that it targets patients with advanced CKD who are ineligible for ISCHEMIA.
“NYU Langone is excited to extend our current research by comparing strategies to treat patients with advanced CKD, an increasingly common condition often associated with ischemic heart disease,” said principal investigator of the ISCHEMIA-CKD trial, Sripal Bangalore, MD, assistant professor, Department of Medicine, Leon H. Charney Division of Cardiology at NYU Langone Medical Center. “Given the aging population, the dramatic increase in obesity and diabetes - all of which are risk factors for kidney disease - the question of how to best manage patients with kidney disease who also have ischemia is exceedingly important. This NIH grant provides us with the opportunity to work with leaders in cardiology and kidney disease from around the world to compare treatment options for these patients.”
The trial, which will be coordinated by NYU School of Medicine, will determine whether an invasive strategy of routine early catheterization followed by optimal revascularization (either by placing stents (PCI) or bypass surgery), in addition to optimal medical therapy (OMT; lifestyle and medications), will reduce the likelihood of death or heart attack in stable ischemic heart disease patients with advanced CKD in an average four-year time frame compared to an initial conservative strategy of OMT alone with catheterization reserved for those who fail OMT. The study will also evaluate angina-related (chest pain associated) quality of life between the invasive and conservative strategies.
Currently, patients suffering from advanced CKD have a 50 percent mortality rate in four years, which is 15-30 times higher than the mortality rate among the general population diagnosed with cardiovascular disease. Despite this, more than 80 percent of cardiovascular disease trials exclude CKD participants.
“NYU Langone is dedicated to continuing its cutting-edge research with studies such as the ISCHEMIA-CKD Trial, to expand upon our ongoing research in the field and provide physicians with enhanced knowledge as they care for patients,” said ISCHEMIA study chair Judith Hochman, MD, MA, Senior Associate Dean for Clinical Sciences, co-director of the Clinical Translational Science Institute, and the Harold Snyder Family Professor of and Associate Director of Cardiology at NYU Langone Medical Center. “Conducting a trial of this nature not only provides an exciting opportunity to be at the forefront of new treatment practices and create an unmatched level of care for patients who suffer from complex illnesses, but demonstrates NYU Langone’s commitment to interdisciplinary and multi-condition focused research.”
Sponsors and collaborators include New York University; Vanderbilt University; Albany Stratton VA Medical Center; East Carolina University; Duke University; Stanford University; National Heart, Lung, and Blood Institute (NHLBI); Harvard University; University of Missouri, Kansas City; Emory University; Cedars-Sinai Medical Center; Massachusetts General Hospital; University of Calgary; Columbia University; and University of British Columbia.