St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, announced the start of its landmark EnligHTNment clinical study. This is the largest randomized, prospective trial to determine whether renal denervation and medication offers additional health benefits beyond lowering blood pressure in patients with uncontrolled hypertension.
The EnligHTNment study will evaluate the EnligHTN™ Multi-Electrode Renal Denervation System and its ability to reduce the risk of major cardiovascular events such as heart attack, stroke, heart failure and cardiovascular death. Prior to the EnligHTNment trial, the majority of renal denervation studies have only tested the safety and efficacy of this technology in patients with drug-resistant hypertension, which is defined as systolic blood pressure above160 mmHg, despite taking three or more anti-hypertensive medications including a diuretic.
“The EnligHTNment trial will provide key insight into whether renal denervation therapy can reduce common cardiovascular complications of high blood pressure that often leave patients disabled or, in some cases, can even be fatal,” said Professor Thomas Lüscher, chairman, cardiology and cardiovascular center at the University Hospital in Zurich, Switzerland, a principal investigator for the trial. “Learning more about renal denervation’s impact on major cardiovascular diseases will provide critical information on the health effects and potential benefits of the therapy in patients who currently don’t have an adequate treatment option.” Renal denervation represents an important area of research in the management of hypertension for the estimated one billion people globally who live with this life-threatening condition. Hypertension occurs when blood pressure in the arteries is elevated, requiring the heart to work harder than normal to circulate blood through the body. The EnligHTNment study is a prospective, randomized, controlled study of approximately 4,000 patients with a systolic blood pressure greater than 160 mmHg. Patients enrolled around the world at up to 150 sites will be randomized to medical therapy plus renal denervation or medical therapy alone. All patients will be followed for five years under an event-driven trial design. Primary endpoints for the study include major cardiovascular events such as heart attack, stroke, heart failure with hospitalization and cardiovascular death.
Secondary endpoints include the reduction of in-office and ambulatory blood pressure and changes in renal function. Renal denervation therapy in the EnligHTNment study will use the EnligHTN Renal Denervation System. Prior studies of this system have demonstrated that patients with drug-resistant hypertension had a safe, rapid and sustained drop in blood pressure. After thirty days, systolic blood pressure was rapidly reduced by an average of 28 mmHg. At six months, it remained stable with an average reduction of 26 mmHg. It is important to note that the risk of cardiovascular death is cut in half with every 20 mmHg decrease in systolic blood pressure.
“St. Jude Medical is pleased to start the landmark EnligHTNment trial to learn more about the long-term effects of uncontrolled hypertension and to see how we can better assists physicians in treating at-risk patients,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division. “We are committed to being a leader in clinical research and have put in place a team of highly respected thought leaders to run this trial. We look forward to working with the steering committee and study investigators in the coming years.”