St Jude Medical, the company behind the Enlightn renal denervation system, has announced that its new study—Enlightnment—will investigate the long-term effects of renal denervation in patients with resistant hypertension to see if the treatment can reduce the risk of major cardiovascular events (such as myocardial infarction) as well as lower blood pressure.
According to a company press release, the Enlightnment trial is the first large-scale study to examine the long-term effects of renal denervation.
“To date, the renal denervation studies that have been conducted only looked at reducing blood pressure in patients with uncontrolled or resistant hypertension,” said Michael Böhm, director and chief of internal medicine and cardiology at the University of Saarland in Homburg/Saar, Germany, a principal investigator for the trial. “What we need to know is if this minimally invasive approach for treating hypertension also correlates to a reduction in major cardiac events such as heart attack, stroke and death, which are the primary risks for patients whose blood pressure is not well controlled.”
“Initial study results have demonstrated that the Enlightn renal denervation system is safe and effective in rapidly lowering blood pressure. If these results extend into the prevention of major cardiac events, there is the potential to dramatically change how we treat these patients,” said Thomas Lüscher, chairman, Cardiology and Cardiovascular Center at the University Hospital in Zurich, Switzerland, a principal investigator for the trial.
The Enlightnment trial will be an international, multicentre, randomised, controlled study examining the safety and effectiveness of renal denervation with the Enlightn renal denervation system in reducing risk of major cardiovascular events.
St Jude Medical is currently conducting two additional renal denervation studies called Enlightn I and Enlightn II that are evaluating the Enlightn system for hypertension. Results to-date from the Enlightn I trial demonstrated that patients with drug-resistant hypertension treated with the St Jude Medical Enlightn system had a rapid and sustained drop in blood pressure.
After thirty days, systolic blood pressure was rapidly reduced by an average of 28mmHg that remained stable with a reduction of 26mmHg points six months after treatment. This is an important finding as the risk of cardiovascular death drops by half with every systolic decrease of 20mmHg. The Enlightn II trial is being conducted at 40 sites in Europe and Australia and will enrol approximately 500 patients with uncontrolled hypertension. The study began enrolment in January 2013 to evaluate the reduction in systolic blood pressure at six months across all enrolled patients after having renal denervation, and within subgroups with varying degrees of kidney functionality.
