On 13 February, Medtronic launched two clinical studies to evaluate the use of its Symplicity renal denervation system for treatment-resistant hypertension across different conditions in a real-world setting.
The studies are the Global SYMPLICITY patient registry which will evaluate the real-world, long-term impact of renal denervation in more than 5,000 patients and the SYMPLICITY-HF which is the first clinical trial to examine renal denervation in patients with chronic heart failure and renal impairment.
“These research initiatives represent part of Medtronic’s broad commitment to partner with the medical community to explore the use of renal denervation in a number of disease states characterised by hyperactive sympathetic nervous system drive,” said Sean Salmon, senior vice president and president, Coronary & Renal Denervation, Medtronic. “Data from the Global SYMPLICITY registry and the SYMPLICITY-HF clinical trial will build upon the substantial renal denervation data Medtronic has generated in patients with treatment-resistant hypertension to date.”
Global SYMPLICITY registry
The Global SYMPLICITY is a multicentre, prospective, open-label, registry that will collect data from 200 centres worldwide of a minimum of 5,000 patients with a number of conditions associated with hyperactive sympathetic nervous system drive, including treatment-resistant hypertension, heart failure, insulin resistance, chronic kidney disease, and sleep apnea. The study will evaluate procedural and long-term safety of renal denervation, as well as efficacy and clinical outcomes.
“Having one comprehensive platform will allow researchers to efficiently and effectively collect robust clinical data and gain important insights into the effects of renal denervation in other disease processes where increased sympathetic tone is believed to be important,” said Michael Böhm, president, German Society for Cardiology, chairman, Department of Internal Medicine, University of Saarland, Homburg/Saar, Germany, and Global SYMPLICITY registry co-chair. “The Global SYMPLICITY registry will allow clinicians worldwide to benchmark procedural practices in diverse patient populations, as well as better understand acute and long-term clinical, quality of life, and cost-effectiveness outcomes.”
SYMPLICITY-HF clinical study
SYMPLICITY-HF is a phase II clinical study designed to evaluate the safety and physiologic response to renal denervation with the Symplicity system in patients with chronic heart failure and renal impairment. The study will enrol approximately 40 adult subjects with chronic heart failure and renal impairment in Europe and Australia. The principal investigators of the study are Professor Henry Krum, director of Cardiovascular Research and Education at the Monash University, Victoria, Australia, and Professor Michael Böhm, director of Klinik für Innere Medizin III and chief of Cardiology at the University of the Saarland, Homburg/Saar, Germany. “In heart failure, reduced cardiac output and renal function are associated with increased sympathetic activity, particularly in the heart and kidneys,” said Krum. “The SYMPLICITY-HF clinical trial will examine whether regulating sympathetic activity through renal denervation may also provide benefit in patients with both heart failure and renal insufficiency, two other conditions characterized by hyperactive sympathetic nervous system drive.”
The Symplicity renal denervation system has been successfully used since 2007 to treat more than 2,000 patients with treatment-resistant hypertension worldwide. It has been commercially available in Europe and Australia since April 2010 but it is not yet approved by the US Food and Drug Administration (FDA) for commercial distribution in the United States. The FDA granted Medtronic approval to conduct SYMPLICITY HTN-3, the company’s US clinical trial of the Symplicity renal denervation system for treatment-resistant hypertension, in August 2011. More information about HTN-3 can be found at www.symplifybptrial.com.