The release of top-line data from the sponsor of SYMPLICITY HTN-3, a large study of renal denervation in hypertension, provided a shock wave to the cardiovascular community.
To some degree, the findings of the study are not surprising. As always, patients who are in clinical trials do well, in this case the sham-operated patients who perhaps at long last were subjected to a focused effort at blood pressure lowering. We will have to wait a while to evaluate the data including subgroup analyses and substudies, but the much ballyhooed effects seen in earlier studies (Lancet 2009;373:1275-81; Lancet 2010;376:1903-9), which did not include a sham-operated arm, now seem to be a series of false leads.
In reading the obituaries, it sounds as if both the company and researchers have quickly opted to move on. But they shouldn’t. There is ample reason to believe that renal denervation may mitigate cardiorenal syndrome, a clinically challenging state that is associated with higher mortality in patients with heart failure. There are a number of small studies underway, the most prominent of which, PRESERVE (Promotion of Renal Sodium Excretion by Renal Sympathetic Denervation in Congestive Heart Failure), is supported by the National Heart, Lung, and Blood Institute. These studies should move forward. It would be a disservice to patients and medical science if one negative study in hypertension, albeit a big one, fails.
Will renal denervation work in heart failure? The studies must go on.
Dr. 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 is an associate editor for Circulation: Heart Failure and blogs while staring out his office window at the Arch.