Just as spring training has begun, the National Institutes of Health has withdrawn funding for an important clinical trial, "Phosphodiesterase Type 5 Inhibition With Tadalafil Changes Outcomes in Heart Failure," or PITCH.
The role of PDE-5 inhibition in heart failure should be fully explored; the fact that the trial will not move forward now is a blow to the heart failure community and most importantly, patients. Although the details are not fully known, it appears that enrollment was slower than anticipated, a common phenomenon when clinical trials are initiated. (Full disclosure: I was in the process of submission of the regulatory paperwork and contracting to participate as a local principal investigator in PITCH when the trial was terminated.)
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Is there any way for the investigators to get back "on the mound" to test the hypothesis? With patents expiring, don't expect industry support to materialize.
PITCH is an example of translational medicine on steroids. A wealth of basic and preclinical data suggested that nitric oxide–induced vasodilation may impact outcomes in human heart failure. A lot of effort, much of it supported by the National Heart, Lung, and Blood Institute, was expended over the last two decades in this area. Indeed, just ask the Nobel Prize winners of 1998.
Is there any way for the investigators to get back "on the mound" to test the hypothesis? With patents expiring, don’t expect industry support to materialize. This leaves us with an important unanswered question. Quite unfortunate, when you think about how much we have examined inhibition of the renin-angiotensin system from every conceivable angle. PITCH needs a reliever. Who will it be?
Dr. Paul Hauptman is professor of internal medicine and assistant dean of clinical-translational research at Saint Louis University, and director of heart failure at Saint Louis University Hospital. He serves as an associate editor for Circulation: Heart Failure and blogs while staring out his office window at the Arch.