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SPYRAL HTN program to evaluate renal denervation for uncontrolled hypertension
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Medtronic announced the launch of a clinical trial program that will assess the use of renal denervation in patients with uncontrolled hypertension, according to a press release.
The SPYRAL HTN global clinical trial program comprises two prospective, randomized, sham-controlled trials: SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED. The trials will be conducted simultaneously. In both, participants will undergo renal denervation by experienced operators with the Symplicity Spyral catheter and Symplicity G3 radiofrequency generator (Medtronic).
SPYRAL HTN-OFF MED will evaluate the impact of renal denervation on BP reduction without the use of antihypertensive medications. SPYRAL HTN-ON MED will assess renal denervation in patients with uncontrolled hypertension despite treatment with three antihypertensive medications; these drugs are not required to be prescribed at maximum tolerated medication dosages, a factor which may have contributed to variability in patient adherence and the large number of medication changes during the SYMPLICITY HTN-3 trial, according to the release.
The trials will include approximately 100 patients with moderate- to high-risk hypertension, enrolled at 20 centers worldwide, according to the release.
“Studying patients both on and off medication in a less severe and more homogeneous population than we saw in the SYMPLICITY HTN-3 trial is critical to gaining clarity on the true effect of this therapy,” Raymond Townsend, MD, director of the hypertension program at the University of Pennsylvania and a principal investigator for the new studies, said in the release. “By specifying medication classes and not requiring maximum tolerated doses, we can expect medication variability to be reduced, which will allow for a more controlled assessment of the impact of renal denervation in the presence of medication.”
Depending on the results of these trials, Medtronic may conduct a pivotal study to support a premarket application to the FDA, according to the release.
Disclosure: The SPYRAL HTN global clinical trial program is sponsored by Medtronic. Townsend is a principal investigator for the trials.