SYMPLICITY HTN-3 Fails to Meet Primary Efficacy Endpoint

The SYMPLICITY HTN-3 trial — the critical U.S. trial in renal denervation for treatment-resistant hypertension — failed to meet its primary efficacy endpoint, according to an announcement made Jan. 9 by the trial’s sponsor Medtronic, Inc.

Additional Resources
  • Trial Summary SYMPLICITY I
  • Percutaneous Renal Denervation in Patients With Treatment-Resistant Hypertension: Final 3-Year Report of the Symplicity HTN-1 Study
  • Looking into the Crystal Ball for Renal Denervation
  • SYMPLICITY HTN-3 was the first blinded, randomized, and controlled trial designed to evaluate the safety and effectiveness of renal denervation with the investigational Symplicity renal denervation system in patients with treatment-resistant hypertension and systolic blood pressure higher than 160 mmHg. The study had randomized 535 treatment-resistant hypertension patients in 87 U.S. medical centers. Patients that that received the investigational treatment were compared with a sham-control group that did not receive treatment, with all patients continuing to take their regular blood pressure medications. The primary endpoints of the study were the change in office blood pressure from baseline to six months and incidence of major adverse events.

    “SYMPLICITY HTN-3 met its primary safety endpoint related to the incidence of major adverse events one month following randomization and renal artery stenosis to six months,” said Deepak L. Bhatt, MD, MPH, FACC, co-principal investigator of SYMPLICITY HTN-3. “Importantly, however, the trial did not meet its primary efficacy endpoint.”

    “While it's disappointing the trial did not meet its primary efficacy endpoint, this is the most rigorous renal denervation clinical trial conducted to date, and the first of its kind to include a sham-control group,” adds George Bakris, MD, co-principal investigator of SYMPLICITY HTN-3. “We look forward to advancing these data into the peer-review process and will submit these findings for presentation and scientific discussion at an upcoming scientific congress.”

    Medtronic is current evaluating the carrying value of the renal denervation assets. Based the trials results, the company believes a one-time impairment charge in the future is likely.

    Keywords: Incidence, Denervation, Blood Pressure, Kidney, Hypertension, Therapies, Investigational

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