Ken Mahaffey

Kenneth W. Mahaffey, MD, Professor and Vice Chair of Clinical Research, Department of Medicine, Division of Cardiovascular Medicine; Director, Stanford Center for Clinical Research, Stanford University School of Medicine

Research Description: Dr. Mahaffey leads the design and conduct of multicenter clinical trials and analyses of important clinical cardiac issues using large patient databases. His focus is testing novel anticoagulants and antiplatelet agents for treating acute coronary syndromes (ACS) and atrial fibrillation (AF), the cardiovascular safety and efficacy of treating diabetes and identifying innovative approaches to improve the efficiency and quality of clinical research methods and procedures. These efforts have resulted in the approval of new therapies for the treatment of patients with ACS or AF and defined the current standard approaches for the ascertainment and adjudication of clinical endpoints. He has led or served on the Executive Committees for many cardiovascular outcome trials, over 125 Clinical Endpoint Committees, and multiple Data Safety Monitoring Boards. He has worked with the FDA and is a consultant for the Endocrinologic and Metabolic Drugs Advisory Committee. Dr. Mahaffey is the on the executive committee of the CANVAS and CANVAS R trials and is the Co-Principal Investigator and Co-Chair of the Clinical Events Committee for CREDENCE. These three trials evaluate the effects of canagliflozin on renal and cardiovascular outcomes in subjects with type 2 diabetes mellitus and diabetic nephropathy. He also directs the Clinical Research Units in SPECTRUM, a CTSA-supported program at Stanford. For example, his staff and members of another unit, the Clinical and Translational Research Unit (CTRU) have assisted Dr. Walter Park to develop the CTC Bio-repository, a human tissue biobank for SDRC investigators. 

Selected relevant publications (Stanford DRC members in BOLD):

  1. Perkovic V, Jardine MJ, Neal B, Bompoint S, Heerspink HJL, Charytan DM, Edwards R, Agarwal R, Bakris G, Bull S, Cannon CP, Capuano G, Chu PL, de Zeeuw D, Greene T, Levin A, Pollock C, Wheeler DC, Yavin Y, Zhang H, Zinman B, Meininger G, Brenner BM, Mahaffey KW, CREDENCE Trial Investigators. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy. N Engl J Med. 2019. 380(24):2295-2306. PMID: 30990260.  

  2. Kim SH, Chang TI, Mahaffey KW. A Call for a New Paradigm for Diabetes Care in the Era of Sodium-Glucose Cotransporter 2 Inhibitors (SGLT2i). Cardiol Ther. 2020 Dec;9(2):219-225. doi: 10.1007/s40119-020-00190-7. PMID: 32661684; PMCID: PMC7584703.  

  3. Rhee JJ, Jardine MJ, Chertow GM, Mahaffey KW. Dedicated kidney disease-focused outcome trials with sodium-glucose cotransporter-2 inhibitors: Lessons from CREDENCE and expectations from DAPA-HF, DAPA-CKD, and EMPA-KIDNEY. Diabetes Obes Metab. 2020 Apr;22 Suppl 1:46-54. doi: 10.1111/dom.13987. PMID: 32267076.